Pfizer

Skin & localized to injection site symptom reports

Female, 26 - 39 years

Age Reported Symptoms Notes
26 2020-12-31 rash Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat.... Read more
Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously. Patient was monitored in the emergency department for improvement of symptoms. Her throat fullness and pruritus resolved. She feels well and wishes to be discharged home. Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged. She will return to the hospital should symptoms worsen. She returned to the ED the next day and these are notes from that visit: 26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction. Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash. She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms. She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel. She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out. She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone. Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures   MDM   Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday.  
26 2021-01-01 injection site pain Fever of 101, chills, severe body aches, mild headache, nausea, pain at injection site
26 2021-01-01 itchy skin, hives fever and headache 5 hours after taking shot. Fever and headache lasted roughly 30 hours. Three days... Read more
fever and headache 5 hours after taking shot. Fever and headache lasted roughly 30 hours. Three days after taking shot started to itch real bad and have hive like bumps. Currently still have itching bumps 4 days after shot
26 2021-01-03 injection site pain By evening, arm around the injection site grew increasingly painful, to the point where it hurt to m... Read more
By evening, arm around the injection site grew increasingly painful, to the point where it hurt to move or touch (not unbearable but more soreness than any other injection I've ever received). Over night contracted a fever, by the time I was able to get up to measure it (around 3:45 AM) it was 99.5 degrees, and broke by 5 AM. Had fever dreams prior to waking around 3 AM, and had chills for the remainder of the night. Felt achy and a little unsteady for the rest of the day but was fully recovered by 12/31
26 2021-01-03 skin discolouration On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outsi... Read more
On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outside of my car for around 15 minutes during a temperature of about 50 degrees. I realized when sharp pain was felt at the digit. After about 5 minutes the digit felt numb. I got in my car, turned on the heater, and massaged my finger. Sharp pain was felt again as circulation returned to the digit. The event last approximately 10 minutes from the moment I realized the finger was pale until color returned. This occurred again on 12/27 at around 2 PM as I walked from my car into a store at a temperature of about 40 degrees. This time, discoloration occurred bilaterally on my left 3rd, 4th, and 5th digits and my right 2nd, 3rd, 4th, and 5th digits. The event lasted more than 15 minutes with constant massaging. This has occurred two more times since then, both times occurring bilaterally with minimal exposure to cold.
26 2021-01-04 rash I am 20 weeks, 4 days. I am due may 20th, 2021. I got the vaccine at work and felt fine. I was getti... Read more
I am 20 weeks, 4 days. I am due may 20th, 2021. I got the vaccine at work and felt fine. I was getting in my pajamas for the night and my husband noticed a weird rash on my body. It did not itch or hurt. I took a shower and a Tylenol and went to bed. I woke up at 5am the next morning and it was completely gone.
26 2021-01-04 vaccination site pain I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; ... Read more
I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
26 2021-01-04 itchy skin Systemic pruritis (itching) all over body; COVID test type: Nasal Swab and Rapid Antigen and were bo... Read more
Systemic pruritis (itching) all over body; COVID test type: Nasal Swab and Rapid Antigen and were both positive; COVID test type: Nasal Swab and Rapid Antigen and were both positive; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscular on 17Dec2020 16:30 at single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and spironolactone. The patient previously took cefprozil (CEFZIL) and tapazole and both experienced allergies. The patient experienced systemic pruritis (itching) all over body on 22Dec2020 10:00. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has been tested for COVID-19. On 22Dec2020, the patient took COVID test type: Nasal Swab and Rapid Antigen and were both positive. No treatment received for the event "Systemic pruritis (itching) all over body". The outcome of the event "Systemic pruritis (itching) all over body" was not recovered. The outcome of the other events was unknown.; Sender's Comments: BNT162b2 provides protection against COVID-19 after 7 days from the second dose. This case does not match this codition
26 2021-01-05 injection site pain -Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flu... Read more
-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs -General fatigue All symptoms subsided after 48 hrs
26 2021-01-05 hives Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began... Read more
Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration
26 2021-01-05 hives Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would ge... Read more
Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache. I have been taking Zyrtec, Benadryl as needed.
26 2021-01-06 injection site pain 12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- ext... Read more
12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.
26 2021-01-06 rash, hives Initial reaction (within 5 min) was minor chest tightening and at the 15 min mark I started to get ... Read more
Initial reaction (within 5 min) was minor chest tightening and at the 15 min mark I started to get hives, I let the nurses know of my reaction and they provided me with Benadryl, I then stayed for about an hour after. It has now been about a week, hives still present and starting to present as a rash.
26 2021-01-06 pain of skin Skin hurting Restlessness Fever Headache Shortness of breath Seeing flashes Malaise Muscle aches
26 2021-01-06 injection site pain, skin peeling, injection site swelling, injection site rash on 7th day post vaccination, I had left upper arm swelling, rash, and pain where there had previousl... Read more
on 7th day post vaccination, I had left upper arm swelling, rash, and pain where there had previously been none. Freckles on that upper arm scabbed over and peeled. This event lasted less than 2 hours. No medications taken, no medical care received. No further reaction since then.
26 2021-01-07 vaccination site pain Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is ... Read more
Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbe: EK5730), via an unspecified route of administration on the left arm on 31Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included anxiety, and covid prior vaccination: Yes. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced arm pain at injection site, fever of 101, chills, severe body aches, mild headache, nausea on 01Jan2021. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
26 2021-01-07 injection site pain Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of inje... Read more
Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of injection site - painful sore ness Chest pain
26 2021-01-07 hives Hives, started 24 hours after vaccine administration, present for about 1 week after vaccine dose, i... Read more
Hives, started 24 hours after vaccine administration, present for about 1 week after vaccine dose, improved with antihistamine therapy. no lip/tongue swelling, shortness of breath, vomiting, syncope, hypotension
26 2021-01-07 redness ITCHING OF TONGUE AND THROAT; REDNESS OF SKIN ON NECK AND SHOULDERS
26 2021-01-07 skin spots Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet an... Read more
Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet and knee area. Patient got CBC and went to PCP. CBC was normal except platelets low-normal 150,000. No itching, swelling, etc. This occurred about 9 days after vaccination. Improved gradually and mostly normalized 3 weeks out when receiving 2nd dose of vaccine. No other symptoms reported besides sore arm for 2 days.
26 2021-01-07 rash rash on body; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exp... Read more
rash on body; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 04Jan2021 14:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to sulfa drug. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cipro [ciprofloxacin] and experienced allergy to cipro. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's husband noticed a rash on the patient's body when the patient was getting into pajamas for bed. She took a shower and paracetamol (TYLENOL) and went to bed. She woke up in the morning and rash was gone. The mother reported she became pregnant while taking bnt162b2. Last menstrual period date was 13Aug2020. The mother was 20 weeks pregnant at the onset of the event. The mother was due to deliver on 20May2021. Outcome of the rash was recovered. The events were considered non-serious by the reporter.
26 2021-01-08 injection site pain Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my thro... Read more
Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my throat started to hurt, and my chest started to hurt. I was a shot of EpiPen and benadryl before I was wheeled down to the ED and was given dexAMETHasone at 1:02pm and ibuprofen at 2:36pm cause my head started to hurt more . Arm is till hurting at the injection site
26 2021-01-08 injection site hives, rash macular, injection site swelling, injection site bruising, injection site pruritus Right side of face started to swell with blotching. It then went away . Injection site is raised , ... Read more
Right side of face started to swell with blotching. It then went away . Injection site is raised , swelling and itching along with bruising . Hives began again on my arms and injection site .
26 2021-01-08 rash diffuse rash, swelling and wheezing
26 2021-01-09 hives, itchy skin, rash About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bila... Read more
About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bilateral arms and face. Around two hours after the vaccination while on the phone with our covid vaccine team, she developed tachycardia and shortness of breath. She called EMS and was evaluated at home at which time her symptoms were improving. They advised that she was not having anaphylaxis and could stay at home. She went to urgent care and received PO Benadryl.
26 2021-01-09 hives Body wide hives and throat tightening
26 2021-01-09 injection site pain Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sle... Read more
Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache
26 2021-01-09 injection site pain Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm... Read more
Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.
26 2021-01-09 skin warm, pain of skin, redness tennis ball size lump, raised, red, hot to touch, painful
26 2021-01-10 injection site warmth, injection site pain, injection site hardening, injection site redness 1.5 hrs after injection, patient noted redness, mild induration, warmth, tenderness; defined 6cm x 4... Read more
1.5 hrs after injection, patient noted redness, mild induration, warmth, tenderness; defined 6cm x 4cm affected area. No change in 3 days since injection; she presented to Health for assessment; site is defined, mild erythema, mild induration, tender. Recommended to apply cold pack, take ibuprofen as anti inflammatory, consult PCP and monitor, and return in 2 days 1/13/21 for update. Advised that PCP may possibly want to prescribe antibiotics if no improvement/resolution (possible cellulitis? does not appear as such to date)..
26 2021-01-10 injection site pain Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the... Read more
Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the night I began experiencing muscle aches, chills, headache, and just an overall feeling of pain/flu like symptoms. This lasted for approximately 24 hours.
26 2021-01-10 redness, itchy skin Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; ... Read more
Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.
26 2021-01-10 injection site pain I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under m... Read more
I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under my left armpit with fever and chills and felt fatigued. My symptoms lasted two days. I slept a lot during the day and day after the injection . I did not get care from a hospital or doctor.
26 2021-01-11 injection site warmth, injection site redness Heat and redness around injection site - occurred one day after injection and continues to be presen... Read more
Heat and redness around injection site - occurred one day after injection and continues to be present
26 2021-01-11 injection site swelling, injection site pain chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fat... Read more
chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fatigue
26 2021-01-11 redness palpitation, redness and tremulous
26 2021-01-12 redness ?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with h... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Pt also received diphenhydramine and famotidine in ER
26 2021-01-12 vaccination site pain Low grade temperature; myalgias; fatigue; neck pain; injection site tenderness; This is a spontaneou... Read more
Low grade temperature; myalgias; fatigue; neck pain; injection site tenderness; This is a spontaneous report from a contactable physician (patient herself). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (right arm), on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left arm), on 17Dec2020, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021 at 21:00, the patient experienced low-grade temperature, myalgias, fatigue, neck pain, and injection site tenderness. The patient did not receive treatment for the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
26 2021-01-12 redness, rash macular Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyp... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Patient also received diphenhydramine and famotidine in ER.
26 2021-01-12 rash macular Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperve... Read more
Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Diphenhydramine and famotidine given in ER
26 2021-01-12 rash papular, redness Post nasal drip, headaches, chills, hot flashes, and red raised bumps that are raised
26 2021-01-12 rash Rash, body aches, migraine
26 2021-01-12 injection site pruritus, injection site pain Site: Itching at Injection Site, Site: Pain at Injection Site
26 2021-01-12 itchy skin, rash papular Started to feel itchy on right neck area approximately 5:25 5 minutes after receiving . Denies pro... Read more
Started to feel itchy on right neck area approximately 5:25 5 minutes after receiving . Denies problems with breathing. No respiratory distress. Lungs ctabl, no stridor, no jvd. RR 12 unlabored even. CV Blood pressure 143/93 97 99% on RA after deep breaths BP 125/88 96b 99% O2 sat. Consulted with Medical Director called 911 for evaluation. Paramedics called and evaluated employee. They recommended on site observation and Benadryl. One 3-4 mm raised blanched wheal at right neck observed, "itchy" scratched x1 when itched. "Tried to not scratch" Denies any respiratory difficulty. Benadryl 25 mg given 6:21 PM, 6:52 employee doing well 98 % 85 heart rate 132/88 16 referral provided for if needed follow up care.
26 2021-01-12 injection site pain, redness Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, swea... Read more
Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.
26 2021-01-12 itchy skin Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. Thi... Read more
Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching
26 2021-01-13 injection site tingling 10 ' after vaccine, developed roof mouth tingling , dizziness , tachycardia and Left arm tingling .
26 2021-01-13 injection site rash, hives Hives and rash on sites of injection and other parts of body
26 2021-01-13 injection site pain I did okay with the first dose only experienced site pain and fatigue. This second dose has not been... Read more
I did okay with the first dose only experienced site pain and fatigue. This second dose has not been pleasant: I am experiencing injection site pain, headaches, body aches, chills, and back pain.
26 2021-01-13 redness, hives Neck and facial hives with swelling. Face was red and hot to tough. Benadryl taken-symptoms resolve... Read more
Neck and facial hives with swelling. Face was red and hot to tough. Benadryl taken-symptoms resolved by am
26 2021-01-13 itchy skin, hives Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observa... Read more
Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.
26 2021-01-14 vaccination site swelling, vaccination site redness, vaccination site pain 2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swe... Read more
2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.
26 2021-01-14 itchy skin I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart ra... Read more
I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart rate went up to 124 beats per minute. I was having flushing, tingling through my whole body. My blood pressure went up to 139/96. I was having itching and blotchiness on my chest, neck, left arm and thighs.This lasted for 3 hours with my heart rate going up and down. I was sent to the ER by the nurses who gave my vaccine. There they gave me Benadryl. 2 tablets of 25mg each. This helped and I was sent home.
26 2021-01-14 vaccination site redness, vaccination site rash Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spo... Read more
Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spontaneous report from a contactable other health care professional. A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1686), intramuscular on 31Dec2020 07:30 at single dose at arm left for COVID-19 immunization. Medical history included GERD, ovarian cysts, obesity, and anxiety. Concomitant medications included fluoxetine, omeprazole, and folic acid. On 11Jan2021 07:00, the patient experienced Injection site redness, rash on arm near injection site, fever in arm, chills, nausea. The patient did not receive treatment for the events. The outcome of the events was recovering.
26 2021-01-14 itchy skin Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vacc... Read more
Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vaccine on 1/10/2021 at 11:30 AM. She received the Pfizer vaccine. She works at a nursing home. She had some fatigue and tiredness during the day but woke up on the second day without any symptoms. On 1/30/2021, she developed bilateral eyelid swelling. The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus. The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising. She denies any hives anywhere else. She does not have a large local reaction at the injection site. She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis. She used Benadryl with significant improvement. She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation. The reaction lasted for 1 week. She received her influenza vaccination in October 20, 2020. She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool. She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction. She has not had this reaction for more than 6 years.
26 2021-01-14 redness, injection site warmth, injection site redness, injection site pain Redness, tender and warm to touch at injection site, redness streaking down to inner side of right a... Read more
Redness, tender and warm to touch at injection site, redness streaking down to inner side of right arm. Noticed redness and tenderness on day 2. Day 3 has slightly more redness surrounding injection site, 2 inch in diameter circular redness, and increased redness down arm. On day 3, the red streak is approximately 1 inch in width and 3 inches in length.
26 2021-01-15 rash, itchy skin, rash macular 11:01 blotchy rash on L neck w/ pulsing sensation L neck. Anxiety, sense of impending doom. BP 167/9... Read more
11:01 blotchy rash on L neck w/ pulsing sensation L neck. Anxiety, sense of impending doom. BP 167/98. Cap refill slow (recorded at 45 seconds). 11:05 25mg benadryl PO 11:09 mild chest pressure without SOB, no throat tightening or difficulty swallowing. 11:25 new R neck itching/rash and chest rash 11:30 another 25mg benadryl PO 12:00 increased rash across torso and back, BP 173/80 Presented to urgent care by 1:00PM, BP 157/96, increasing chest pressure, rash improving. EKG 12-lead completed (NSR w/ sinus arrhythmia). Instructed to take PO Benadryl 50mg every 4hrs.
26 2021-01-16 injection site pain I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased... Read more
I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased over the course of two days. At approximately 12:30AM on 1/16/2021, extreme nausea, vomiting, fever, chills, and muscle aches began. During the day on 1/16/2021 severe joint pain (specifically bilateral knees and hips, and spine) occurred, somewhat relieved by Tylenol. On 1/17/2021 at 1:15AM, intense nausea, vomiting, and fever occurred again. As of 9:15AM on 1/17/2021, body aches and joint pain are returning and nausea is persistent.
26 2021-01-17 injection site pain, skin warm, injection site hardening, injection site redness, cellulitis 8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection s... Read more
8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection site. Exam notable for 7cm region of erythema, with central induration. region is warm, mildly tender to palpation. no severe swelling. also tender Left axillary adenopathy. no fever, chills. no systemic systems. Pt very well appearing. presentation concerning for cellulitis.
26 2021-01-17 injection site pain Burning when it went in, tingling left arm down to hand, left left foot. Feels like it's gett... Read more
Burning when it went in, tingling left arm down to hand, left left foot. Feels like it's getting worse. Advised to see PCP.
26 2021-01-17 rash, rash macular, itchy skin, redness I started to notice some itching on my arms and chest and behind my ear so I went to the bathroom t... Read more
I started to notice some itching on my arms and chest and behind my ear so I went to the bathroom to check it out and I noticed the right side of my face was getting red and blotchy looking. I went to talk to the doctor and while I was conversing with her my tongue started to get tingly and started to swell. I took 50mg of benedryl and kept an eye on my symptoms and the tongue swelling started going down but the rash is still there.
26 2021-01-18 itchy skin, hives After the first shot of Pfizer, I started to have cold sore ( never have cold sore before). I starte... Read more
After the first shot of Pfizer, I started to have cold sore ( never have cold sore before). I started to take cold sore shield pills one a day and using abreva to treat cold sore. While I am still treating cold sore, I received 2 nd dose of Covid. After exact 1 week of 2nd shot, I had an allergy reaction. I was driving to work and had hive throughout of face, neck and torso. Unknown the cause, no new cream/regime for face, no new food, and no other new medications. Beside hives and itchiness, no other upper respiratory distress s/s. The hives went away after 30 minutes.
26 2021-01-18 itchy skin Patient returned to vaccine center approximately 30 minutes after being discharged(initially waited ... Read more
Patient returned to vaccine center approximately 30 minutes after being discharged(initially waited 15min with no symptoms)-upon return patient c/o initial tingling to lips and then itching across face. Treated with 25mg Benadryl, monitored for 40 min. Vital signs remained stable and patient stated that she felt better upon leaving the center.
26 2021-01-18 rash Shooting pain up L arm, nausea, dizziness, rash, increased BP
26 2021-01-18 itchy skin The patient experienced itching after the first dose of the COVID-19 vaccine. Pre-medicated with dip... Read more
The patient experienced itching after the first dose of the COVID-19 vaccine. Pre-medicated with diphenhydramine prior to the 2nd dose of the OVID-19 vaccine. 9 minutes after the vaccination, the patient felt itchy, flushed and received oral dexamethasone. [atient was sent out with oral dexamethasone home.
26 2021-01-18 injection site pain Vaccine given 1/15/21, on 1/16 and 1/17/21 reports arm soreness "felt like my arm was being ripped o... Read more
Vaccine given 1/15/21, on 1/16 and 1/17/21 reports arm soreness "felt like my arm was being ripped off" on evening of 1/7/21 bad headache, On 1/18/21 symptoms continued and overnight into Tuesday 1/19/21 Temp 101.3 chills and aching body, headache continues.
26 2021-01-18 itchy rash, itchy skin, rash with redness, rash macular generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccin... Read more
generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID. The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.
26 2021-01-19 injection site pain Fatigue, body aches, injection site pain, chills
26 2021-01-19 injection site pain Headache, fatigue, body ache, injection sore soreness
26 2021-01-19 itchy rash, rash with redness, skin warm, hives Hives noted the following morning that were described as red, hot and itchy. Located on chest, head... Read more
Hives noted the following morning that were described as red, hot and itchy. Located on chest, head, hands and arms, side of right hip. Used Claritin and ice packs with some relief. Also experienced numbness on her left shoulder and left chest to navel which subsided by mid day. No breathing issues or any additional signs or symptoms.
26 2021-01-19 injection site pain, hives Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, sor... Read more
Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, soreness at injection site, and chills. Jan 13th- chills and fatigue. Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue, body aches and chills. Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue, body aches, chills, sore throat, left ear pain and nausea. Jan 20th- sore throat, body aches, fatigue, hives
26 2021-01-19 injection site pain Symptoms within first 6-24 hours of receiving 2nd dose: moderate pain at injection site, body/muscle... Read more
Symptoms within first 6-24 hours of receiving 2nd dose: moderate pain at injection site, body/muscle aches, chills, intermittent headache and fatigue
26 2021-01-20 itchy skin, vaccination site pain, vaccination site swelling Itching; Nausea; Headache; Body ache; Site soreness and swelling; Site soreness and swelling; This i... Read more
Itching; Nausea; Headache; Body ache; Site soreness and swelling; Site soreness and swelling; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in right arm, on 21Dec2020 at 19:45, at a single dose, for COVID-19 immunization. The patient's medical history included sciatica. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was a hospital. After the first dose on 21Dec2020 (from the day of injection and for 2 days post), the patient experienced itching, nausea, headache, body ache, and site soreness and swelling. Treatment was received for the adverse events which included paracetamol (TYLENOL) at 500 mg. Since the vaccination, the patient has been tested for COVID-19. Polymerase chain reaction (PCR) nasal swab for COVID-19 that was negative on 04Jan2021. The patient recovered from the events in Dec2020. No follow-up attempts are possible. No further information is expected.
26 2021-01-20 vaccination site pain Sore injection site; This is a spontaneous report from a contactable pharmacist (patient). A 26-year... Read more
Sore injection site; This is a spontaneous report from a contactable pharmacist (patient). A 26-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 08:45 at single dose on right arm for covid-19 immunisation. Medical history included asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No Covid prior vaccination. The patient previously took bactrim and experienced drug hypersensitivity. The patient experienced sore injection site on 24Dec2020 12:00. Outcome of event was recovered. No treatment received. No covid tested post vaccination. Information about Lot/batch number has been requested.
26 2021-01-20 itchy skin, rash Upper chest rash, and itchy
26 2021-01-21 rash vesicular 26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states sh... Read more
26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states she received her vaccine at 3pm, approx 1-2 hrs later started to notice left sided lip numbness that radiated to her left ear and left side of head. No difficulty speaking, no facial heaviness, no changes in vision or hearing. No n/v, no fevers. No previous similar episodes. ED states low suspicion for any stroke, states may be an early bell's palsy vs a pre-rash zoster. Unlikely to be reaction to vaccine. Some slight improvement during ED stay.
26 2021-01-21 rash I got the vaccine in 1/18/21 and started getting a body rash on 1/20/21 and had chest pains.
26 2021-01-21 redness Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 h... Read more
Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 hour later while the charge was eating lunch on plaza and c/o of face swelling/feeling flushed. RN walked patient to ER. In the ED, pt reports bilateral eye swelling, facial redness, scratchy throat. Pt initially felt SOB but breathing ok now. No tongue swelling.
26 2021-01-21 itchy skin, hives Within five minutes I felt very faint and dizzy along with nausea. Then came the shortness of breath... Read more
Within five minutes I felt very faint and dizzy along with nausea. Then came the shortness of breath and the feeling of pins and needles which also brought itching and some minor hives with it. The dizziness, nausea, and feeling of fainting went away after about 10 minutes and I had to go to the Emergency Department to take care of the shortness of breath and hive like reaction. I was given some medications and they diagnosed it as a moderate allergic reaction to the vaccine. I was completely fine with the first one.
26 2021-01-23 injection site pain Pain at site, nausea and chills and fatigue
26 2021-01-24 rash maculo-papular, rash, itchy rash Maculopapular rash presented on neck and jaw approximately 6 hours following vaccination. Slightly p... Read more
Maculopapular rash presented on neck and jaw approximately 6 hours following vaccination. Slightly pruritic, no other symptoms noted. Resolving at the time of this report, following hydrocortisone cream application - approximate duration of 48 hours.
26 2021-01-24 skin warm Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got... Read more
Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got really hot while the rest of my body stayed cold. A small headache began to turn into a migraine. During the night, my body began to hurt beyond achy causing me to toss and turn. When I woke up in the morning, I couldn't stand even the littlest of pressure placed on my body. For example, my cat jumped on my leg and it felt like someone wacked me with a baseball bat because of how sensitive my body was. The only treatment used for myself during this time was Tylenol. It helped with the head aches. Overall, it took me about three nights to actually feel ok again.
26 2021-01-24 itchy skin all over itchiness, no rash or bumps, intermittently itchy all over body when L arm is itchy, a mosq... Read more
all over itchiness, no rash or bumps, intermittently itchy all over body when L arm is itchy, a mosquito bite size bump appears but subsides within 30 minutes after itching area
26 2021-01-25 rash, redness Reported dizziness, cold extremities, redness in left ear and rash on left shoulder noted. Mild anx... Read more
Reported dizziness, cold extremities, redness in left ear and rash on left shoulder noted. Mild anxiety. 25 mg Benadryl po administered. Returned to work at 10:25 am. No reaction to first dose reported.
26 2021-01-26 hives Over the course of 5 days I broke out in hives all over my body
26 2021-01-27 vaccination site swelling, vaccination site redness, vaccination site pain Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; Sw... Read more
Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; body aches; low grade fever; First dose on 21Dec2020, second dose on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 05Jan2021 at single dose for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EH9899 on 21Dec2020 07:45 PM, at age of 26 years old, via Intramuscular in right arm for covid-19 immunization and experienced itching, nausea, headache, body ache, site soreness and swelling. Medical history included sciatica. The patient's concomitant medications were not reported. The patient experienced swelling redness and soreness at injection site, body aches, low grade fever all on 05Jan2021 with outcome of recovered in Jan2021. The patient underwent lab tests and procedures which included PCR nasal swab for COVID-19 negative on 04Jan2021. The patient received paracetamol (TYLENOL) 500mg for treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
26 2021-01-27 vaccination site pain severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib... Read more
severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.
26 2021-01-28 injection site pain Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection si... Read more
Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)
26 2021-01-28 injection site pain Fatigue for 2 and half days. Increased blurred vision while driving and watching television. Tender... Read more
Fatigue for 2 and half days. Increased blurred vision while driving and watching television. Tender at injection site.
26 2021-01-28 injection site pain Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough... Read more
Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough for a fever. I took Bayer for the muscle pain and slept. Developed soreness of injection site approximately an hour after injection. Muscle stiffness and joint pain began that night. Other symptomst started Thursday morning and ended Friday morning.
26 2021-01-28 injection site pain fatigue, body aches, back pain, pain at injection site
26 2021-01-28 injection site mass, injection site hardening in the injection site she has a "large mass hard and stiff"; large mass and it hasn't resolved. The ... Read more
in the injection site she has a "large mass hard and stiff"; large mass and it hasn't resolved. The area was really hard and stiff; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 07Jan2021 07:00 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She received the first dose of the vaccine on Thursday and in the injection site she has a "large mass hard and stiff", she's concerned about this and she would like to know what she can do. In the injection area a large mass and it hasn't resolved. The area was really hard and stiff. Wanted to know if she should be concerned or be seen. Received the first dose on 07Jan2021 and kind of had this issue with the injection arm all week and maybe noticed it Tuesday because she was afraid to sleep on that side. No history of problems with vaccines in past. She is due for the second dose on 28Jan2021. Caller later provides that she is breastfeeding at the moment, but no further details provided. The events did not result to a physician office and emergency room visit. Vaccination Facility Type was hospital. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done and no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event was reported as non-serious. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051752 mother/baby
26 2021-01-29 injection site pain Muscle ache localized to the right arm, shoulder and neck. Significant tenderness in R deltoid (inje... Read more
Muscle ache localized to the right arm, shoulder and neck. Significant tenderness in R deltoid (injection site).
26 2021-01-29 itchy skin Pfizer COVID- 19 Vaccine Pt received Pfizer COVID vaccine lot #EL3249. Pt sat for about 10 minutes, ... Read more
Pfizer COVID- 19 Vaccine Pt received Pfizer COVID vaccine lot #EL3249. Pt sat for about 10 minutes, arm became itchy, gave diphenhydramine x 1 dose. Pt continued to sit for assessment for another 15 min. Pt stated she felt hot, but is typical for her to feel warm. No chest pain, SOB, blurred vision. Pt cleared to leave facility.
26 2021-01-30 hives hives/welts /Nausea / Back pain
26 2021-01-31 rash, redness Following 1st COVID-19 vaccination she began having generalized fever, body aches, fatigue, and near... Read more
Following 1st COVID-19 vaccination she began having generalized fever, body aches, fatigue, and near syncope prompting her to go to the ED, 2 days after the vaccine. She also began having diffuse swelling of the LUE and L chest wall. Swelling down to elbow prior with erythema and mild rash, which I visualized in a photo. Unsure if blanched. Resolved over several days and was without symptoms when I saw her. Had IV in AC area for IVFs on impacted side but denied symptoms of infiltration.
26 2021-01-31 injection site pain I experienced sweating, chills, fatigue and sore at the injection sight. I was sore at the injection... Read more
I experienced sweating, chills, fatigue and sore at the injection sight. I was sore at the injection site right after it was administered. I then experienced severe chills in the evening, starting at about 7pm. The next morning I woke up fatigued and alternated between sweating and having the chills and shaking.
26 2021-01-31 itchy skin Intense itching palms, soles of feet, axilla, inner forearms, wrists. Lasting from 1/23/21 to prese... Read more
Intense itching palms, soles of feet, axilla, inner forearms, wrists. Lasting from 1/23/21 to present and has not resolved. No change in laundry detergent/soaps/lotions, no known allergies, no medication changes recently.
26 2021-01-31 hives, redness, itchy skin, rash Patient's reaction(s) noted during COVID vaccine observation period: hives and redness/itching to s... Read more
Patient's reaction(s) noted during COVID vaccine observation period: hives and redness/itching to sides of abdomen. No sob, chest pain noted. Actions Taken: Vital signs taken, observed for 30 minutes. Advised to monitor rash at home and take antihistamines as needed. Patient verbalized understanding. Disposition: Home
26 2021-01-31 itchy rash Pt presented 24 hours post COVID-19 vaccine (Pfizer) with systemic rash which was pruritic. Multiple... Read more
Pt presented 24 hours post COVID-19 vaccine (Pfizer) with systemic rash which was pruritic. Multiple lesions on trunk, axilla, groin which appeared pus pustular seen at clinic, prescribed Zyrtec, antifungal cream and hydrocortisone cream. I discontinued the creams and placed on oral steroid burst. still no improvement.
26 2021-01-31 injection site pain headache, body aches, chills, left arm pain, fatigue
26 2021-01-31 vaccination site pain tenderness at injection site; This is a spontaneous report from a contactable nurse (patient). A 26... Read more
tenderness at injection site; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK5730, unknown expiration), via an unspecified route of administration in left arm on 16Dec2020 at 06:30 AM at a single dose for COVID-19 immunization in a hospital. Medical history included asthma and allergy to sulfa drugs. Concomitant medications included albuterol, montelukast sodium (SINGULAIR), and unspecified multivitamin. The patient reported that she has no reaction after receiving the first dose other than slight tenderness at injection site in Dec2020. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was tested for COVID post vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 06Jan2021. Outcome of the event was unknown.
26 2021-02-01 hives, rash papular A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; A few hours... Read more
A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; woke up with bumps on both of the arms; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 16Jan2021 12:30 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, osteoarthritis, allergies: general anaesthesia. The patient was not pregnant. Concomitant medication included phentermine and vitamin D3. On 17Jan2021 at 10:00 am the patient woke up with bumps on both of the arms. A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives. Patient began to take Benadryl twice a day. On 18Jan2021 at 6:00 am the hives began to appear on both arms again and back. On 19Jan2021 the patient woke up at 6:00 am and the hives appeared on both arms, back, chest, stomach, both legs, neck and parts of the face. Therapeutic measures were taken as a result of rash papular and urticaria which included Benadryl, while no treatment received for skin disorder. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Facility type vaccine was other. No other vaccine in four weeks. No COVID prior vaccination. Not COVID tested post vaccination. Information on lot/batch number has been requested.
26 2021-02-01 blister Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest... Read more
Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
26 2021-02-01 itchy skin Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that nig... Read more
Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that night into Sunday and Monday. Chills and muscle aches
26 2021-02-01 injection site pain Muscle aches, weakness, fever, chills, slightly swollen face and lymph nodes, injection site pain, f... Read more
Muscle aches, weakness, fever, chills, slightly swollen face and lymph nodes, injection site pain, feeling unwell, fatigue.
26 2021-02-01 itchy skin The patient experienced itching after the first dose of the COVID-19 vaccine.; This is a spontaneous... Read more
The patient experienced itching after the first dose of the COVID-19 vaccine.; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), intramuscularly on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itching after the first dose of the covid-19 vaccine in Dec2020 with outcome of unknown.
26 2021-02-02 injection site tingling I am a pharmacist for pharmacy and received my first dose of Pfizer Covid-19 vaccine while at work b... Read more
I am a pharmacist for pharmacy and received my first dose of Pfizer Covid-19 vaccine while at work by another pharmacist. Vaccine given around 2:15 PM on 2/2/21 Less than 5 minutes after vaccine - arm tingling at site of injection, arm tingling spread from injection site to fingers, tingling and pins/needles traveled through underarm area and moved across left side of chest, slight chest pain on left side, whole body started tingling, dizziness, racing heart. While experiencing all of these symptoms, I sat on the ground, took two tablets of 25mg Benadryl, drank water, and tried to breath steady to make dizziness go away. Working in this healthcare setting, I was aware I was having an adverse reaction to the vaccine and was prepared with an epi-pen in case of any severe anaphylaxis shock - I did NOT have to use the epi-pen. Less than 15 minutes after vaccine - the chest pain, arm pins/needles stopped, I felt lightheaded still, another co-worker checked my blood pressure which had risen to 178/120 and pulse of 120. About 1 hour after vaccine - still felt light headed, blood pressure still elevated at 158/107, pulse of 107. Around 5:45 PM - After consulting personal friend physicians, I was instructed to go to ER and have an EKG of my heart since my blood pressure and pulse had spiked so high and suddenly. I was able to find coverage at work so that I could leave my shift and get a ride to the emergency room. After 6 PM (admitted into ER) - upon admission blood pressure of 176/117 and pulse of 113
26 2021-02-03 vaccination site pain Mild injection site soreness; more tired than usual which extended into the following day; This is a... Read more
Mild injection site soreness; more tired than usual which extended into the following day; This is a spontaneous report from a contactable consumer (patient's parent). A 26-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 12Jan2021 11:00 to 12Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON). On 12Jan2021, the patient had mild injection site soreness and 3-4 hours after receiving the vaccination and noted being more tired than usual which extended into the following day. The events were assessed as non-serious as per the reporter. The patient did not received any treatment for the events. The patient is not pregnant at the time of the report. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
26 2021-02-03 vaccination site redness, vaccination site mass, vaccination site itchiness small bump at site with redness and mild itchiness; small bump at site with redness and mild itchine... Read more
small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old female patient was administered the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular (left arm) on 17Jan2021 16:30 at single dose for Covid-19 immunization. The patient was administered the first dose of BNT162B2 (lot number: EL0140) on 29Dec2020 at left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient previously took Amoxicillin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 (also reported as "day 6 post vaccine"), the patient experienced small bump at site with redness and mild itchiness. There was no treatment received for the adverse event. The outcome of events was unknown. The outcome of events was unknown. The patient has not been tested for COVID-19 since the vaccination.
26 2021-02-04 itchy skin, hives Hives all over body, facial swelling, rapid heart rate, itching. Reaction lasted 20-30 minutes. Flu-... Read more
Hives all over body, facial swelling, rapid heart rate, itching. Reaction lasted 20-30 minutes. Flu-like symptoms (fatigue, chills, runny nose) followed.
26 2021-02-04 sensitive skin Sore arm a few hours after getting the shot Next morning, sore arm, very sensitive skin, temperature... Read more
Sore arm a few hours after getting the shot Next morning, sore arm, very sensitive skin, temperature of 99.7
26 2021-02-04 vaccination site pain arm pain at the injection site; fever (100 degrees F) later that night lasting into the next day; Th... Read more
arm pain at the injection site; fever (100 degrees F) later that night lasting into the next day; This is a spontaneous report from a non-contactable consumer. A 26-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EK9231) intramuscularly on 20Jan2021 (at the age of 26-years-old) at 0.3 mL as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received dose 1 of BNT162B2 intramuscularly on 30Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 21Jan2021 at 00:00, the patient experienced arm pain at the injection site and fever (100 degrees Fahrenheit (F)) later that night lasting into the next day. The patient did not receive any treatment for the events. There was no hospitalization for the events and the reporter assessed the events as non-serious. The clinical outcomes of arm pain at the injection site and fever (100 degrees F) were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
26 2021-02-04 vaccination site pain, vaccination site mass hard large lump that hurts at the injection site /Left arm has a knot in it from injection site; ha... Read more
hard large lump that hurts at the injection site /Left arm has a knot in it from injection site; hard large lump that hurts at the injection site; chest pain; shortness of breath; This is a spontaneous report from contactable consumer (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration into the upper left arm on 05Jan2021 at single dose as a precaution because she works in nursing home (COVID-19 immunisation). Medical history included Covid positive back in Oct2020. Concomitant medication included biotin and one a day women's vitamin. Family members have medical issues. Dad has heart tumors, seizure, sleep apnea and osteoporosis. Mom has asthma, diabetes, has had cancer, neuropathy and macular degeneration. The patient received first dose of the covid vaccine on 05Jan2021 and had some symptoms after the vaccine. On unspecified date in Jan2021, the patient hard large lump that hurts at the injection site, chest pain and shortness of breath; similar to when she had Covid positive back in October. She still has a lump at the injection side which has gotten smaller in size but still hurts to touch. Left arm has a knot in it from injection site; does not reuired ER or visit to physician's office. It feels like a bump with something in her arm. She doubts that is the case. She wanted to see if that was normal and when it might go away, especially since she should be getting second dose on 26Jan2021. She is a speech therapist. There is no prescriber. They came and gave to everyone all at once. It was really big at first. It felt like someone punched her. It was a big giant lump, but it is getting better. The injection was given in the upper left arm and it felt like it went into the muscle. The outcome of the event vaccination site mass was recovering, and the outcome of the remaining events was unknown.
26 2021-02-04 itchy skin, vaccination site hardening, vaccination site swelling, vaccination site warmth, vaccination site redness, vaccination site pain itchiness; Injection site reaction of firmness beneath skin; Injection site reaction of swelling; In... Read more
itchiness; Injection site reaction of firmness beneath skin; Injection site reaction of swelling; Injection site reaction of redness; Injection site reaction of warmth; Injection site reaction of soreness; This is a spontaneous report from a non-contactable pharmacist (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unknown route of administration in the left arm on 19Jan2021 at 16:30 (at the age of 26-years-old) as a single dose for Covid-19 immunization. Medical history included skin of upper arm is affected by mild eczema/atopic dermatitis, keratosis pilaris, hypertrophic scarring all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to latex which causes a rash/ swelling. The patient's concomitant medications were not reported (did have other medications in two weeks, unspecified). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 20Jan2021 reported as for first day, the patient experienced Injection site reaction of firmness beneath skin, swelling, redness, warmth, soreness and on the second day also experienced itchiness. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pain was not recovered; pruritus was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
26 2021-02-06 hives, itchy skin Hives, diffuse over body. Intense itching on hands, legs, stomach, scalp, chest, and neck. Would wel... Read more
Hives, diffuse over body. Intense itching on hands, legs, stomach, scalp, chest, and neck. Would welt up then disappear and then reappear. Start time 3:00pm 2/5/21 and is ongoing. Antihistamines and IM 4mg decadron shot taken. Helped for a time but symptoms have proceeded.
26 2021-02-07 rash Description of adverse event - Upon disrobing in order to shower for the evening, I noticed a rash, ... Read more
Description of adverse event - Upon disrobing in order to shower for the evening, I noticed a rash, primarily on my torso, but also on my arms. I had not noticed it before this time. I had not noticed itching or any other side effects other than the (expected) arm pain. Treatment - 50 mg of Benadryl Outcome - rash is still present at this time (11:05 PM, Monday 2/8)
26 2021-02-07 hives Event #1: I experienced a small outbreak of hives on my left cheekbone within 15 minutes of receivin... Read more
Event #1: I experienced a small outbreak of hives on my left cheekbone within 15 minutes of receiving the vaccine. The staff gave me an injection of Benadryl into my right arm. The spot reduced in size over the duration of an hour and I was sent home with instructions to take OTC Benadryl until the swelling disappeared completely later that evening. Event #2: Shortness of breath and chest tightness beginning exactly 74hrs after the vaccination (Sunday, 01/31/2021 at 2:15pm). This side-effect continues to persist and is not due to a true Covid-19 infection.
26 2021-02-07 redness Felt fine until 12 hours after 2nd dose - extreme nausea and vomiting, high fever, alternating chill... Read more
Felt fine until 12 hours after 2nd dose - extreme nausea and vomiting, high fever, alternating chills and sweats for ~6 hours. 40 hours after dose, woke up and had several painful bumps on vulva and labia- small and white, slight redness around them. No history of STDs, more than a year since last sexual activity. Did some googling to figure out what it was and closely matched what was described/photos in this paper .Searched "aphthous ulcers vulva" to confirm using more photos, and determine treatment/if I needed a doctor, and came across a web site, which then led me to believe they bumps were related to the vaccine. Treated with over the counter hydrocortisone 1% every 12 hours for a total of 4 applications, and bumps are mostly painless and reduced in size.
26 2021-02-07 hives Hives all over back and hips.
26 2021-02-07 vaccination site swelling Nausea; Fever; Chills; Body aches; Lethargy; Injection site inflammation and swelling; Injection sit... Read more
Nausea; Fever; Chills; Body aches; Lethargy; Injection site inflammation and swelling; Injection site inflammation and swelling; This is a spontaneous report from a non-contactable healthcare professional reporting for self. This 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9261) on 20Jan2021 10:00 AM at single dose (vaccine location=left arm) for COVID-19 immunisation. Medical history was none. No known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=EL0140) on 30Dec2020 07:15 PM at single dose (vaccine location=left arm) for COVID-19 immunisation. The were no other vaccine in four weeks, patient did not have COVID prior vaccination. Patient was not pregnant. The patient experienced nausea, fever, chills, body aches, lethargy, injection site inflammation and swelling on 21Jan2021. No treatment received. Patient did not test COVID post vaccination. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.
26 2021-02-07 hives, injection site redness, injection site pruritus Patient had itching/redness at the injections site (Left arm). Developed hives on the right arm. No ... Read more
Patient had itching/redness at the injections site (Left arm). Developed hives on the right arm. No itching in throat. Patient was given diphenhydramine 12.5 mg.
26 2021-02-07 hives, injection site hives, injection site redness, redness Pfizer-BioNTech COVID-19 Vaccine EUA: Patient vaccinated at COVID-19 Vaccine Center. They were broug... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient vaccinated at COVID-19 Vaccine Center. They were brought to observation area and proceeded to have hives and reddening of face, neck and injection site. BLS (EMS) treated patient on site and patient escorted out via wheelchair.
26 2021-02-07 rash rash going down her arms; This is a spontaneous report from a contactable consumer. A 26-year-old f... Read more
rash going down her arms; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash going down her arms on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.
26 2021-02-08 injection site hardening, injection site warmth, injection site redness Local reaction - skin surrounding vaccine site erythematous, warm, and indurated for 3-4 days.
26 2021-02-08 injection site pain Soreness at injection site as well as anterior shoulder pain. Soreness at injection site resolved., ... Read more
Soreness at injection site as well as anterior shoulder pain. Soreness at injection site resolved., but continues to have anterior shoulder pain.
26 2021-02-08 rash papular, hives, itchy skin These symptoms started the evening of my vaccine and lasted for 4 days (1/28/2021 through 1/31/2021)... Read more
These symptoms started the evening of my vaccine and lasted for 4 days (1/28/2021 through 1/31/2021). Uncontrollable chills, severe body aches, upper/middle back pain, neck pain/stiffness, extreme fatigue, ear aches, raging frontal and occipital headache, and hives (white in color on both legs - inner knee area), itchy neck and chest. Benadryl taken for hives. Ibuprofen taken for other side effects. No treatment/OTC medication provided real relief until late evening of day 3 after vaccine. Hives and side effects resolved entirely after 4-5 days post-vaccine. White hives turned into red healing rash-like bumps and eventually disappeared entirely.
26 2021-02-11 rash papular, hives Hives on lips - tiny red bumps on outer edge of top and bottom lips, swollen lips - both top and bot... Read more
Hives on lips - tiny red bumps on outer edge of top and bottom lips, swollen lips - both top and bottom, both lips bright red
26 2021-02-14 rash, hives, itchy rash Abdominal rash/hives that is itchy, hives on neck, back and Left elbow crease. SOB with daily activi... Read more
Abdominal rash/hives that is itchy, hives on neck, back and Left elbow crease. SOB with daily activities. Lightheadedness. Symptoms began 3 days post 2nd vaccine and continue to progress.
26 2021-02-14 itchy skin, hives, rash Chills- night of vaccine all the way through the next day 2/13 Muscle aches & exhaustion- 2/13/21 la... Read more
Chills- night of vaccine all the way through the next day 2/13 Muscle aches & exhaustion- 2/13/21 lasted all day for one day. Required extra sleep + acetaminophen & ibuprofen Hives- Woke up 2/14 will small itchy patches all over the body (shoulders, back, stomach, legs, hands, feet). Took benadryl for treatment. Still itching all day 2/15/21 Sharp chest pain 2/14. Pain started halfway through the day and throughout the night. OTC pain medication had no effect. Disappeared after sleeping and waking up on Monday 2/15 Swollen lymph node in the left armpit (vaccine arm)- slight pain/tenderness. Started 2/14 in the morning. Still slightly tender as of end of the day 2/15
26 2021-02-14 hives I developed cold urticaria the day following receiving the second dose of the COVID vaccine, I know ... Read more
I developed cold urticaria the day following receiving the second dose of the COVID vaccine, I know develop hives when outside in temperatures <37 degrees Fahrenheit and swelling and hives when touching cold objects. I was seen by a doctor who diagnosed this condition, and he believes it is directly related to the COVID vaccine.
26 2021-02-15 redness I received my COVID19 vaccines on 12/31/2020 and 1/21/2021. On 2/3/2021 I woke up with pain, swellin... Read more
I received my COVID19 vaccines on 12/31/2020 and 1/21/2021. On 2/3/2021 I woke up with pain, swelling, redness, and decreased range of motion in my R elbow at the site where I had hardware (wires, pins, tension band) placed during a surgical repair of my olecranon process in 2013. I have never had any issues with this elbow since the surgery, and no illnesses/dental work/medication changes in the months before this. The only change was getting my COVID vaccine. I went to see my PCP Dr. who advised me to go to the ER due to fear of a potential infection based on these symptoms. I went to the ER and after extensive testing they ruled out this being an infectious cause, though I was put on PO doxycycline as a precaution. An orthopedic specialist came to see me and determined that my body is essentially rejecting the hardware and I need to have surgery to have it removed. Since then, the swelling has decreased, however I still have persistent pain in my elbow along the site where the hardware is inserted and limited mobility due to pain with certain movements that put tension on this joint. I will need to have surgery eventually to have the hardware removed but am hoping to wait a couple months so that I can complete nursing school. I was advised to report any potential side effects from this vaccine and am choosing to do so as I do not know of any other reason this could be happening.
26 2021-02-21 injection site rash, itchy skin Area of red raised bumps in the shape of a square directly below injection site with accompanying pr... Read more
Area of red raised bumps in the shape of a square directly below injection site with accompanying pruritus. Onset is not known however, first noticed it 2 days after injection.
26 2021-02-22 itchy skin Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER ... Read more
Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.
26 2021-02-22 itchy skin, hives Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadry... Read more
Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadryl PO. At 7 minutes post vaccination had c/o feeling warm and having a headache. Vitals taken, vitals repeated 5 minutes later, still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back. At 11:15 an additional 25 mg tablet of Benadryl PO was given.
26 2021-02-22 itchy skin, hives Pt came in to have 2nd vaccine pt started to notice her arm itching and saw hives PT alerted us and ... Read more
Pt came in to have 2nd vaccine pt started to notice her arm itching and saw hives PT alerted us and was taken in medical evaluation room where she was given 50 mg of benadryl Pts hives went away with no other reaction Pt left via POV
26 2021-02-23 redness Orange-ish yellow color appeared on hands (color of iodine) was noticed on Saturday Night 2/20/21 ... Read more
Orange-ish yellow color appeared on hands (color of iodine) was noticed on Saturday Night 2/20/21 and lump developed above left clavicle noticed Sunday Morning 2/21/21. No treatment was performed.
26 2021-02-23 injection site pruritus Patient complained of tingly lips, itchy left arm (near vaccine site). Patient waited 30 minutes wi... Read more
Patient complained of tingly lips, itchy left arm (near vaccine site). Patient waited 30 minutes with improvement of symptoms and left the site.
26 2021-02-24 hives Facial hives/hives on the face; might have caused a flare of my kidney disease; might have caused a ... Read more
Facial hives/hives on the face; might have caused a flare of my kidney disease; might have caused a flare of my kidney disease; This is a spontaneous report received from a contactable consumer (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 27Jan2021 09:45 on left arm at single dose for COVID-19 immunisation. Medical history included liver transplant and kidney disease. The patient previously took amoxicillin and had allergies. The patient did not receive other vaccine in four weeks prior to vaccination but received other medications (unspecified) in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27Jan2021 12:00, the patient experienced facial hives/hives on the face and reported that it might have caused a flare of my kidney disease. The seriousness of the events was considered as non-serious by the reporter. Therapeutic measures were taken as a result of event facial hives/hives on the face included Benadryl. The outcome of the event hives was recovering, whereas unknown for other events.
26 2021-02-26 itchy skin 830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensati... Read more
830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensation internally. Medications to stop allergic reaction given by IV. Discharged home. Slight fever currently, muscle and body aches and pains. Joint pain. Headache.
26 2021-02-26 injection site warmth, injection site swelling, injection site redness Swollen muscle where injection was given, hot to touch, redness around Injection mark
26 2021-02-28 injection site mass Bumps in inner upper arm
26 2021-02-28 vaccination site pain Slight pain at the injection site; muscle and joint aches (mostly in shoulders and back) which caus... Read more
Slight pain at the injection site; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; Slight nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 26Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA), valacyclovir, cyanocobalamin (B12), iron, and colecalciferol (D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021, the patient experienced slight pain at the injection site, muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night, and slight nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
26 2021-02-28 bruising Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding i... Read more
Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at the left arm on 21Jan2021 09:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has previously been vaccinated with the first dose of BNT162B2 (lot number: Pfizer 1284) on 30Dec2020 11:00 at the age of 26-year-old, intramuscular at the left arm for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient experienced swollen Lymph nodes following second dose for five days, large lump underneath left armpit expanding into left breast formed and caused limited ROM, immense pain, and bruising on 21Jan2021. The patient did not receive any treatment for the events. The patient has recovered from the event swollen lymph nodes on 26Jan2021 and recovered on an unspecified date for the rest of the events.
26 2021-02-28 vaccination site pain fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the ar... Read more
fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the armpit underneath the injection site; pain and tenderness at injection site as well as in the armpit underneath the injection site; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis (not yet clear if Hashimoto's or Graves), appendicectomy and pyelonephritis. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride (VALACYCLOVIR HCL), ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium. The patient did not receive other vaccine in four weeks. The patient previously took azithromycin but drug allergy. The patient received the first dose of of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 05Jan2021 02:15 PM at a single dose for covid-19 immunization but had pain and tenderness at the injection site. It was reported that the patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine in a hospital on 26Jan2021 12:15. On 27Jan2021 12:00 AM, the patient had fever, chills, headache, overall fatigue, pain and tenderness at injection site as well as in the armpit underneath the injection site. The events required treatment which included acetaminophen. The outcome of the events was recovering. Information on the lot/batch number has been requested.
26 2021-03-01 injection site pain I got the shot on February 5th, 2021. On the day of my injection, I immediately felt a stiffness in ... Read more
I got the shot on February 5th, 2021. On the day of my injection, I immediately felt a stiffness in my arm within 10 minutes of receiving the shot. I didn't think too much of it because I had some stiffness in my arm with the first shot. But this Friday - March 5th will be a month and I am still having arm issues and they have gotten worse. I never had a rash or bruise on the injection site but from the injection site I have a tenderness on my arm and a constant dull and achy pain - sometimes sharp and painful - that starts at the injection site then travels down through my elbow and into my hand. My hand will get tingly and numb as well. My arm will sometimes randomly fall asleep as well. I went to the doctor but they gave me ibuprofen and that didn't do much. I am going back to the doctor soon.
26 2021-03-01 vaccination site swelling It seems like she was drunk; it was almost like disorientation like; Had trouble processing like for... Read more
It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer. Medical history was none. There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine "it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much." No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
26 2021-03-02 vaccination site swelling Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; S... Read more
Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.
26 2021-03-02 vaccination site pain, vaccination site swelling Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right ... Read more
Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right arm); Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). This 26-year-old non-pregnant female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via unspecified route of administration in the right arm on 27Jan2021 at 11:00 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have COVID-19 prior to vaccination, and did not receive any other vaccines in the 4 weeks prior to vaccination. Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; ibuprofen (ADVIL) from an unknown date for an unknown indication; and ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unknown indication. On 27Jan2021 at 21:00 the patient experienced soreness and swelling at injection site (right arm), fatigue, nausea, and headache, all lasting 24 hours after inoculation. No treatment was received for the events. The clinical outcomes of soreness and swelling at injection site (right arm), fatigue, nausea, headache, were recovered on 28Jan2021 at 21:00. It was also reported the patient did not test for COVID-19 post vaccination.
26 2021-03-02 injection site pain headache, body aches, injection site pain, GI upset and severe swelling of lymph nodes under my L ar... Read more
headache, body aches, injection site pain, GI upset and severe swelling of lymph nodes under my L arm (axillary region) at this time I have a golf ball sized lymph node in my L armpit that is tender to the touch
26 2021-03-03 hives, itchy skin hives on arms, neck on day 1. burning sensation. still hives on 3/4/21 but resolving with Benadryl, ... Read more
hives on arms, neck on day 1. burning sensation. still hives on 3/4/21 but resolving with Benadryl, limited to arms. itchy but less severe.
26 2021-03-04 rash Rash on neck and chest that lasted about 10-12 days ? No itching or irritation, just lots of spots. ... Read more
Rash on neck and chest that lasted about 10-12 days ? No itching or irritation, just lots of spots. Fatigue.
26 2021-03-04 hives, itchy skin, rash Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 mi... Read more
Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 minutes I had hives on my chest in back. I had high blood pressure 180/120, facial puffiness and mild bottom lip swelling. I developed an onset of increased mucus in my throat causing me to clear my throat frequently. RN on site reported no throat swelling, but increased thickness due to mucus. I received a Benadryl injection on site within 30 minutes and almost immediately symptoms began to lessen. The next day I had mild bottom lip swelling, body itchiness, chest rash, headache and fatigue. Today (24 hours after vaccine) I have a headache, fatigue and body itchiness.
26 2021-03-05 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain Intermittent Chills Intermittent headache I... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain Intermittent Chills Intermittent headache Intermittent dizziness Fatigue Soreness in arm of injection
26 2021-03-06 hardening Hard swollen lymph node under left side of neck, began 3 days post injection and still ongoing.
26 2021-03-07 hives Day off, hives up entire arm and loss of strength in right arm. Took Benedryl to calm it. Next day, ... Read more
Day off, hives up entire arm and loss of strength in right arm. Took Benedryl to calm it. Next day, very weak and sore arm. Very little movement or strength. Third day, weak but able to slowly lift arm above head.
26 2021-03-07 injection site warmth, injection site redness, injection site rash Red, hot to touch rash around injection site that continues to grow.
26 2021-03-08 injection site pain, itchy rash, hives, rash papular, rash with redness, injection site reaction I developed a red, itchy, raised and tender welt/rash around my injection site. "Covid Arm."
26 2021-03-09 cellulitis, injection site pain, injection site redness Increased pain and redness at injection site greater than 24 hours after vaccine. Fevers and chills.... Read more
Increased pain and redness at injection site greater than 24 hours after vaccine. Fevers and chills. Diagnosed as cellulitis, treated with a 10 day course of antibiotics.
26 2021-03-09 injection site pain, injection site pruritus Temporary burning/itching at injection site, headache, tiredness, upset stomach
26 2021-03-10 injection site pain Fatigue, injection site pain
26 2021-03-10 injection site pain, injection site swelling, injection site pruritus Pain and swelling at injection site, muscle of injected arm is achy, hard to lift even to shoulder-h... Read more
Pain and swelling at injection site, muscle of injected arm is achy, hard to lift even to shoulder-height, itching at injection site, body aches, headache, upset stomach/nausea (but no vomiting or diarrhea)
26 2021-03-11 hives 5:28pm received 1st Covid-19 vaccine. At 5:40 c/o slight throat tightness. O2 sat 99, Pulse 100, B/P... Read more
5:28pm received 1st Covid-19 vaccine. At 5:40 c/o slight throat tightness. O2 sat 99, Pulse 100, B/P 128/80. At 5:45pm c/o tongue tingling. 5:49pm hives on chest and c/o chest tightness. Denies SOB. O2 sat 99, pulse 130, B/P 124/72. 5:50pm 0.5 mg Epi administered IM left thigh and EMS activated. 5:50pm pulse 110, B/P 130/82, O2 sat 98%. Transported to hospital at 6:02pm per ambulance.
26 2021-03-11 itchy rash, rash A week after my shot and I'm still having strange reactions. The day after the shot I started gettin... Read more
A week after my shot and I'm still having strange reactions. The day after the shot I started getting really bad cramps and other PMS symptoms like bloating and tenderness (even though I'm on a type of birth control that means I don't get a period). Then a few days later I started my period and has continued. I also have developed the kind of rash that I get when I eat wheat--all over my body and itchy and it hasn't gone done. Finally, it also caused a lot of digestive issues and bloating and gas. it makes me very nervous to get my next shot.
26 2021-03-11 rash macular, itchy skin Red splotches, itching, tingling in face and lips Given Benadryl
26 2021-03-12 hives Patient had a minor reaction - reported feeling flush and hives. Patient developed symptoms at 30 m... Read more
Patient had a minor reaction - reported feeling flush and hives. Patient developed symptoms at 30 min waiting period. She was given 50mg of diphenhydramine and observed for additional time. Patient reported feeling better after receiving diphenhydramine.
26 2021-03-13 injection site pain Pain at injection site an entire month after the second dose
26 2021-03-14 itchy skin Mild/moderate itchiness all over the body set in after a few hours and has persisted to the current ... Read more
Mild/moderate itchiness all over the body set in after a few hours and has persisted to the current time.
26 2021-03-14 rash with redness, blister, shingles, rash papular Within 8 hours of receiving dose #2 of the Covid 19 vaccine, developed shingles rash on left waist,... Read more
Within 8 hours of receiving dose #2 of the Covid 19 vaccine, developed shingles rash on left waist, left lower back and buttock and left abdomen. The rash was red, raised with blisters. She had no fever. She was given Tylenol, and Benadryl to prevent pain and itching. At this point (10 days post vaccine) the rash appears to be healing, blisters have scabbed over and some scabs falling off.
26 2021-03-16 rash, itchy rash Mildly itchy, rash on back of arms/armpits
26 2021-03-16 itchy skin, redness Redness and itching noted after injection. Advised to take PO Benadryl once home. Patient has a hist... Read more
Redness and itching noted after injection. Advised to take PO Benadryl once home. Patient has a history of itching after vaccinations
26 2021-03-16 hives, redness, itchy skin Within 10 minutes of observation post-Pfizer COVID vaccine. Pt c/o itching to lower back. The RN vis... Read more
Within 10 minutes of observation post-Pfizer COVID vaccine. Pt c/o itching to lower back. The RN visualized redness along pant line, approximately palm sized. Waited 5 minutes with continued observation and patient stated continued itchiness but h/o multiple allergies. Denies SOB, no oral swelling noted, RR even and unlabored. Assessed torso with no further significant hives but previous still visible. Pt given 25 mg po Benadryl. Pt requested to go home, denied acute distress, states she has Zyrtec at home. Pt with coworker who stated pt will remain with them for next few hours and they would monitor her symptoms. Pt given s/s to monitor for, when to go to ED if acute symptoms, and to notify MD of possible allergy. Pt agreed with Plan of Care.
26 2021-03-18 injection site pain Injection site pain (immediate), muscle pain (12 hours after), dizziness (15 hours after).
26 2021-03-18 rash, injection site rash The night of the vaccine: body aches 24 hours later: chills, body aches 42 hours later: morbillifo... Read more
The night of the vaccine: body aches 24 hours later: chills, body aches 42 hours later: morbilliform rash on neck, injection site, stomach, and back
26 2021-03-21 injection site pain 103 degree fever, headache, fatigue, muscle and joint pain, injection site pain, chills, fever, and ... Read more
103 degree fever, headache, fatigue, muscle and joint pain, injection site pain, chills, fever, and nausea. Developed symptoms starting at about noon the day after vaccination and progressively got worse throughout the afternoon and evening. Symptoms made it impossible to conduct normal activities but have mostly resolved in the second day.
26 2021-03-21 injection site swelling, injection site pruritus, injection site redness, injection site pain, injection site warmth ?COVID arm? - red, painful, swollen, hot, itchy skin around injection site, about 3 inches in diamet... Read more
?COVID arm? - red, painful, swollen, hot, itchy skin around injection site, about 3 inches in diameter. Painful to sleep on.
26 2021-03-21 injection site pain, itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain tiredness headache stuffiness muscle pain, ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain tiredness headache stuffiness muscle pain, pain at base of head and top of neck, hip pain, knee pain chills fever (2 days at 100F) nausea dizziness itchiness
26 2021-03-22 injection site pain I was 34 weeks at the time of vaccination. Initially, I only had pain at the injection site. I woke ... Read more
I was 34 weeks at the time of vaccination. Initially, I only had pain at the injection site. I woke up the next day with diarrhea that lasted about 6 days. I had no other symptoms besides dehydration and back pain. On Day 3, I was instructed to take Imodium, which I took for about 2 days, but it didn't help. Around Day 5, I was given fluids, my urine was tested and multiple GI tests were run. I was placed on antibiotics for a UTI. PVCs were also discovered at visit, but it's not connected to the vaccine.
26 2021-03-22 rash, itchy skin, hives Patient described itching and rash on skin. She would scratch her skin and break out in hives where ... Read more
Patient described itching and rash on skin. She would scratch her skin and break out in hives where she scratched. The itching would intensify and then go away and move to a different area of her body. 80% of the itching is on her back, neck, shoulders, and legs. She shared that the injection site is unremarkable. At time of call, she was trying to get a hold of her health care provider.
26 2021-03-22 rash, redness, skin warm Sore throat starting the next day possibly connected to the high pollen count rash no itching just w... Read more
Sore throat starting the next day possibly connected to the high pollen count rash no itching just warm and red skin
26 2021-03-23 bruising Monday I received the vaccination (1st of the 2). Tuesday I started seeing bruises on my right side ... Read more
Monday I received the vaccination (1st of the 2). Tuesday I started seeing bruises on my right side (I was vaccinated in my right arm). I can see 5 bruises. 1 on my right arm. 4 on my right thigh. All are various shapes (dime sized to quarter size) but they are all more of a darker yellowish bruise. I did test positive for Covid back in November 2020 and didn't need any medical treatment. I was told that 90 days out was okay for receiving the vaccination.
26 2021-03-23 bruising Night sweats, body aches, disrupted sleep, bruised/very sore arm
26 2021-03-23 rash Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Medium
26 2021-03-24 rash I developed a rash ten minutes after receiving the second dose. On my neck and it trailed down to ch... Read more
I developed a rash ten minutes after receiving the second dose. On my neck and it trailed down to chest area. They took me to Urgent Care and they gave me Benadryl and the Rash went away.
26 2021-03-24 redness Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minu... Read more
Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minutes after leaving 11:30 I could taste the vaccine in my mouth. I immediately felt intense sharp tingling in my lower lip, it felt hot and swollen (upper lip never had a reaction). I instantly felt a lump in my throat and had a hard time swallowing. I started with chest pain that resolved itself in a minute or two. A few minutes later a family member noticed my face was red and flushed and said I looked like I had a sun burn. Swelling in throat resolved within an hour. Lip never visually looked swollen but I could feel the tightness, burning and tingling that resolved within the hour. Redness on face resolved within a couple hours. Had tiny blisters about 3 show up above upper lip I still have them the next day with a couple more but they aren't causing problems. My airway was never blocked I never had a hard time breathing. I did have a sore throat this morning March 25 day after vaccine. All other symptoms seem normal.
26 2021-03-25 injection site pain Fever, chills, body aches, muscle and joint pain, nausea, vomiting, diarrhea, trouble concentrating ... Read more
Fever, chills, body aches, muscle and joint pain, nausea, vomiting, diarrhea, trouble concentrating , headache. These symptoms lasted about 30 hours. Headache, trouble concentrating, pain at injection site have lasted almost 48 hours and continue to exist but have been reduced over time
26 2021-03-25 skin warm Vision change 20-30 seconds Nausea/vomiting Lightheaded Sweaty Warm Paresthesia in hands
26 2021-03-27 itchy skin Less than 3 minutes after administration, I began having tingling in my throat. My heart began to ra... Read more
Less than 3 minutes after administration, I began having tingling in my throat. My heart began to race. I grabbed a medically professional who assessed me, she stated I was beginning to flush and then had EMS respond. Vital signs indicated a peak heart rate in the 160?s, O2 Sats were in the 80?s. I also had a metallic taste in my mouth and a tightness in my airway. Later in my hour observation I had a period of facial flushing and itching. I had ice packs placed on my skin, given a fluid bolus and monitored by an RN and EMS personal. A Doctor assessed me and contemplated transporting to the ED for management but I was slowly feeling improvement. I was monitored for an hour and felt okay when I left the clinic.
26 2021-03-28 injection site pain Employee reports after second dose onset on chills, and soreness to injection site. sxs resolved on ... Read more
Employee reports after second dose onset on chills, and soreness to injection site. sxs resolved on own. Employee reports having both Pfizer vaccines 1st dose 12/23/20, 2nd dose 1/12/21. Employee became symptomatic and tested Covid positive 3/25/21. BWH Infection contact tracing team has identified the employee as contracting Covid by a Community Contact. Employee quarantining at this time.
26 2021-03-30 vaccination site pain Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a ... Read more
Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered. The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.
26 2021-04-04 rash, itchy rash, rash macular, rash with redness I developed a Severe rash (blotchy, red, itchy ) all over both arms and back 36 hours post 2nd dose ... Read more
I developed a Severe rash (blotchy, red, itchy ) all over both arms and back 36 hours post 2nd dose Pfizer vaccine. I had a high fever of 103 and massive headache too and body aches
26 2021-04-15 itchy skin After receiving first COVID vaccine patient reported tasting metal, itchiness in right leg. Patient ... Read more
After receiving first COVID vaccine patient reported tasting metal, itchiness in right leg. Patient was monitored for an additional 10 minutes, no additional symptoms were noted during while being monitored.
26 2021-04-24 redness, itchy skin, rash About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, ... Read more
About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; My throat was also just a little bit tight and breathing was labored/Little tightness around the throat; My throat was also just a little bit tight and breathing was labored; allergic reaction; rash all over my face; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm at the age of 26-year-old on 07Apr2021 14:40 (Lot Number: 7131121) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included lung transplant from 2016 (recipient of double lung transplant in 2016), Slight damage to the windpipe, Asthma, immunocompromised. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prednisone; metoprolol; magnesium chloride. The patient previously took cefdinir (OMNICEF) and experienced drug allergy, clarithromycin (BIAXIN) and experienced drug allergy. Patient got her shot at 2:40 pm. Seemed fine, waited at the star for 15 minutes and went on her way. About an hour after patient looked in the mirror and saw that her entire right cheeck was bright red, hot, and itchy on 07Apr2021 15:30. Her throat was also just a little bit tight and breathing was labored on 07Apr2021 15:30. Patient went to the emergency room and was given 25mg of oral Benadryl, 20mg of famotidine, and a dexamethasone shot. Patient was then observed and released once her reaction started to calm down. Consumer stated, she was calling because she had a allergic reaction to her first dose of the Pfizer Vaccine yesterday (07Apr2021). It did occur just after half an hour of the Vaccine on 07Apr2021 15:10. She broke out in a rash all over her face in Apr2021. Little tightness around the throat. Therapeutic measures were taken as a result of 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored'. Adverse events 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored' result in Emergency room/department or urgent care. The outcome of events rash all over my face and allergic reaction was unknown. The outcome of other events was recovered in Apr2021. No follow-up attempts are possible. No further information is expected.
26 2021-04-25 rash I received my second dose of Pfizer around 3pm on Sunday, April 4 2021. By about midnight, I had a f... Read more
I received my second dose of Pfizer around 3pm on Sunday, April 4 2021. By about midnight, I had a fever and the fever/headache and exhaustion persisted throughout Monday. I did not take any medicine. By Tuesday morning, my fever broke, but I developed a large 6 inch rash under my left armpit (my second shot was in my right arm as I am left handed). By Tuesday afternoon, I had developed a bad cough. Given that I work remotely, and had only been to a grocery store (double masked) with my mother a few days prior to the second dose, I assumed the cough was a result of the second dose. My cough become worse, and by Wednesday it sounded like bronchitis so I went to my doctor. She believed that it was a bronchitis cough, had me tested for viral infections, and put me on a variety of medications from antibiotics to steroids and inhalers. I tested negative for all the respiratory illnesses I was tested for, as well as COVID-19. The medications did not seem to help, and my doctor added another inhaler and medication to the mix. After about 2 weeks of medications and no improvements, my doctor had me get a chest X-ray to make sure I didn?t have pneumonia or any other obstruction in my lungs. I also stopped all medication on Tuesday, April 20. My chest X-ray came back clear later that week, and I decided to just stay off all medications and hope that my body would self heal, since this seemed to be a self created bronchitis, as my parents did not get sick. Finally, after 2 weeks and 4 days, my cough has improved significantly to the point where I can now talk almost normally, without going into coughing spasms and feeling as though it was difficult to breathe.
26 2021-04-26 injection site pain Severe headache, sinus congestion, dizziness, nausea, diarrhea, heavy menstrual period, fatigue, dro... Read more
Severe headache, sinus congestion, dizziness, nausea, diarrhea, heavy menstrual period, fatigue, drowsy, muscle pain, injection site soreness
26 2021-04-29 hives 10 minutes after shot throat was itchy, 30 minutes after shot throat was more itchy and broke out in... Read more
10 minutes after shot throat was itchy, 30 minutes after shot throat was more itchy and broke out in hives across chest and outside of throat
26 2021-05-04 injection site pruritus, injection site hives, injection site warmth, injection site pain, injection site hardening Exactly a week after receiving the shot, a bright red welt appeared on the injection site. It was ho... Read more
Exactly a week after receiving the shot, a bright red welt appeared on the injection site. It was hot to the touch, hard, tender, and was itchy if scratched. It stayed hard, tender, bright red, and hot to the touch for three days before disappearing on its own. Having taken the second shot over a week ago, the welt hasn't reappeared. If you want to reach out to me, I have photographs.
26 2021-05-05 bruising I had a couple of bruises to pop up but I didn't known if I hit my leg on something or not. Still th... Read more
I had a couple of bruises to pop up but I didn't known if I hit my leg on something or not. Still this is the longest I've ever had bruises to last on my leg. It feels over worked. Also, my body feels shaky sometimes. I'm not sure if it's my nerves since I just lost someone close to me or from this shot. I've never felt shaky at random like this. It feels like my heart races when that occurs, too. It never last long, either.
27 2020-12-31 injection site pain, injection site warmth I woke up with significant right-sided facial and eye swelling currently still present although impr... Read more
I woke up with significant right-sided facial and eye swelling currently still present although improved in severity. Other symptoms included pain/heat at injection site, myalgias, fatigue.
27 2020-12-31 itchy skin, redness, skin warm shoulder redness/itching/warmth starting 7 days after injection. Advised to use warm compress/Tylen... Read more
shoulder redness/itching/warmth starting 7 days after injection. Advised to use warm compress/Tylenol/Benadryl. Advised f/u in UC or ED for any new/worsening symptoms of any kind
27 2021-01-03 hives I experienced hives to my abdomen and back.
27 2021-01-03 itchy rash, injection site rash Patient started develop itchy rash on arm near injection site. The diameter of the rash was about 4 ... Read more
Patient started develop itchy rash on arm near injection site. The diameter of the rash was about 4 inches and developed in about 20 minutes after injection. We gave her an ice pack to apply over the area and a tablet, crushed of Benadryl.
27 2021-01-03 rash The Sunday after I received the vaccine I had increased hip pain and Sunday night I had a rash anon ... Read more
The Sunday after I received the vaccine I had increased hip pain and Sunday night I had a rash anon the L2 and L3 dermatome. I thought it was shingles and made an appt. Overnight the rash spread and it was very painful, On Monday I got Volcite for 7 days and I still have rash (improving) and pain today.
27 2021-01-03 rash with redness, skin warm dime size reddish bump, warm to touch
27 2021-01-03 skin warm, rash, skin warm, rash received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakene... Read more
received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00
27 2021-01-04 injection site redness Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was test... Read more
Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.
27 2021-01-05 rash, itchy rash 12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone cr... Read more
12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone creme Outcome as of 1/4, fever gone, rash continues.
27 2021-01-05 hives, redness Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly as... Read more
Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.
27 2021-01-05 hives I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and ... Read more
I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and felt like their was acid in my stomach (burning sensation). I had a headache. Was in the ED 12/31/20. Symptoms continue to happen at random.
27 2021-01-05 hives I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I fe... Read more
I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I felt nauseated and there was a burning in my stomach. I had a headache. I have been experiencing these symptoms at random since the vaccine.
27 2021-01-05 injection site pruritus, vaccination site warmth, vaccination site pain, rash Patient developed acute pain, itching and warmth at site of vaccine administration. She developed a ... Read more
Patient developed acute pain, itching and warmth at site of vaccine administration. She developed a rash extending to the top of the LEFT shoulder into the LEFT earlobe
27 2021-01-05 injection site pain sore injection site the next day, next day at 10am began experiencing aches in my joints and achey m... Read more
sore injection site the next day, next day at 10am began experiencing aches in my joints and achey muscles all over, mild headache, fatigue. At around 1pm experienced chills and fever. Experienced 3 episodes of diarrhea that started about 5 hours after the vaccine.
27 2021-01-05 injection site pain tenderness at injection site; mild swollen lymph nodes
27 2021-01-06 shingles, rash Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days la... Read more
Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days later I had an area of papules on my anterior thigh the size of a half dollar. The right sided back pain then began to radiate around to my hip and the rash began to be painful. My right thigh eventually began to tingle and and the pain increased in severity. On Jan 7th I presented to the acute care clinic at the Clinic and was diagnosed with shingles.
27 2021-01-06 injection site warmth, injection site redness, injection site swelling Redness, warm to touch, and swelling at injection site. Treatment-Benadryl and cold compresses
27 2021-01-06 injection site pain Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back,... Read more
Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021
27 2021-01-07 injection site mass Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomit... Read more
Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.
27 2021-01-07 skin mass, skin swelling Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. ... Read more
Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. About 24 hours after the 2nd dose, I noticed the area around my left collar bone was swollen . The area is painful to touch and contains a lump about the size of a dime. Pain is experienced when I attempt to cross my left arm over my body. Lump and pain still remains 51 hours after vaccination.
27 2021-01-07 injection site swelling Body Aches, Chills, Vomiting, Extreme tiredness, Swelling at the injection site.
27 2021-01-07 itchy skin, injection site mass Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: i... Read more
Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches
27 2021-01-07 itchy skin, hives, redness Hives, Redness, itchy, leg tremors, nervous 25 mg Benadryl PO administered
27 2021-01-07 hives Hives; This is a spontaneous report from a contactable other health professional. A 27-year-old fema... Read more
Hives; This is a spontaneous report from a contactable other health professional. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, Expiry Date: Mar2021, NDC number: 5926710001), via an unspecified route of administration on 30Dec2020 08:11 at a single dose in right bicep (right arm) for COVID-19 immunisation. Medical history included urinary tract infection from 21Dec2020 to Dec2020 which was resolved and fine after the antibiotic, ongoing eczema (had this condition basically her entire life), ongoing sensitive skin (always had pretty sensitive skin). Concomitant medication not reported. The patient previously took nitrofurantoin (MACROBID [NITROFURANTOIN]) from 24Dec2020 to 28Dec2020. The patient experienced hives on 01Jan2021 09:00 (also reported as "got it last Wednesday morning and broke out in hives the next day"). Patient stated, "I have a question to you. I got the Covid Vaccine, the Pfizer Vaccine on Wednesday morning like around 8 o' clock and this morning I woke up and I broke out hives. I didn't know if in two days, I just want to report my symptoms just to make sure everything is okay." The hives were bad on Friday and took Benadryl and Cortisone cream and it is better now. The hives are not worse; not as bad as it was on the first day. She took about 5 Benadryl throughout the first day: 01Jan2021. Over the last few days she has continued to get small breakouts of hives on pretty much every single spot on her body except for her face; the hives seem to kind of take turns in different areas of the body but have not gone away. She has used Hydrocortisone, lotion and Benadryl for the hives. The outcome of the event was recovering. She is both a sonogram technologist as well as the patient. She asked if she should or should not receive the second dose of Pfizer COVID- 19 Vaccine in response to the hives. She is supposed to get second dose on 19Jan2021; unknown if she will or will not change dose scheduling in response to event at this time.
27 2021-01-07 vaccination site pain I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was develop... Read more
I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.
27 2021-01-07 injection site swelling, skin discolouration, injection site warmth injection site was swollen and hot and doubled in size also reports fatigue and slight discoloration... Read more
injection site was swollen and hot and doubled in size also reports fatigue and slight discoloration.
27 2021-01-07 vaccination site redness, vaccination site pain, vaccination site warmth, vaccination site swelling lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, pai... Read more
lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious. Information on the Lot/Batch Number has been requested.
27 2021-01-07 hives swollen left eye, hives on arms and legs, stuffy/runny nose
27 2021-01-08 injection site pain Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the ... Read more
Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.
27 2021-01-08 hardening side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by feve... Read more
side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by fever and muscle aches. Highest fever was 101.7 F. side effects were bad enough to affect ability to do ADLs and to be able to go to work. Swollen lymph node in left clavicle since first dose got bigger and firmer. since symptoms have resolved swollen lymph node still there.
27 2021-01-10 injection site pain, injection site bruising, injection site swelling Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain a... Read more
Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***
27 2021-01-10 injection site rash, injection site redness, itchy rash, rash papular I had redness injection site and little rash. I notice little red spots. The 2nd day I receive bumps... Read more
I had redness injection site and little rash. I notice little red spots. The 2nd day I receive bumps on both arm, which was very itchy. The 3rd day my whole body was fill with the bumps. The bumps lasted for a week.
27 2021-01-10 injection site redness, cellulitis, injection site swelling, injection site hardening, injection site pain, injection site warmth Medication was administered subcutaneous not intramuscular. Cellulitis occurred, site was warm, red,... Read more
Medication was administered subcutaneous not intramuscular. Cellulitis occurred, site was warm, red, swollen, painful and hard. Was prescribed keflex by ID DR on Saturday, 1/9/2020. Site continued to grow until Monday, 1/12/2020.
27 2021-01-10 injection site redness, injection site rash Once I receive the shot; my arm became red. I start seeing red bumps around the area I receive the s... Read more
Once I receive the shot; my arm became red. I start seeing red bumps around the area I receive the shot. My next day I had itchy bumps on both arms. By the 3rd day my whole body was covered with bumps. That lasted for a week.
27 2021-01-10 rash Tachycardia and palpitations within 5 minutes of administration. Lasted for about 5 minutes then re... Read more
Tachycardia and palpitations within 5 minutes of administration. Lasted for about 5 minutes then resolved. Approximately 20 mins after administration of vaccine minor swelling of the throat and limited rash on the throat present. 50 mg oral Benadryl taken an hour after vaccination.
27 2021-01-10 itchy skin numbness in toes itchy arm hurts face swelling all over swelling of the body
27 2021-01-10 injection site swelling, injection site redness, injection site redness, itchy skin swelling redness at injection site, itching, muscle pain, not feeling well-all resolved
27 2021-01-11 itchy skin Itching 2 days after it was given.
27 2021-01-11 hives, skin irritation, itchy skin Patient complained of itching dermatitis throughout torso and face with visible hives. Patient compl... Read more
Patient complained of itching dermatitis throughout torso and face with visible hives. Patient complained of throat "feeling funny". Patient immediately transported by wheelchair 300 ft to ED.
27 2021-01-11 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA: 1. Injection site tenderness x 2-3 days, no treatment 2. Fatig... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: 1. Injection site tenderness x 2-3 days, no treatment 2. Fatigue, severe headache, muscle pain, fever x 8-10 hours (started about 10 hours after getting the vaccine), Tylenol
27 2021-01-11 hives Urticaria; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female pat... Read more
Urticaria; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular on 18Dec2020 at a single dose on the left arm as vaccine. Medical history was not reported. There were no concomitant medications (did not receive other vaccines within four weeks to the COVID vaccine and did not receive other medications within two weeks of vaccination). The patient had no known allergies to medications, food, or other products. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). The patient experienced urticaria on 18Dec2020 assessed as non-serious which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not pregnant at the time of vaccination. She was not diagnosed with COVID-19 prior to vaccination. She had Covid tested post vaccination (had been tested for COVID-19 since vaccination)- nasal swab result negative on 31Dec2020. Treatment for the event included Benadryl. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.
27 2021-01-11 vaccination site pain body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection si... Read more
body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection site was extremely sore; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ek9231/expiration date unknown), dose number 1, via an unspecified route of administration on 03Jan2021 14:15 at a single dose on the left arm for COVID-19 immunization. Medical history included migraines. Concomitant medications were not reported. The patient was fine the day she got the vaccine, but when it came to the night of 03Jan2021, she wasn't able to sleep due to the pain throughout her arm. On 04Jan2021 04:00, she woke up with a headache that was intense, fever, and body chills. The injection site was extremely sore to the point where she took some Tylenol and slept it off. On 05Jan2021, she felt a lot better, but still with mild body aches. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 since the vaccination. The vaccine was received in a hospital. No other vaccines were given in four weeks. The outcome of the events was not recovered for body aches, and recovering for the other events.
27 2021-01-11 hives developed hives on arm along with fever, chills and muscle aches. Self treated and symptoms resolve... Read more
developed hives on arm along with fever, chills and muscle aches. Self treated and symptoms resolved
27 2021-01-11 injection site redness, injection site swelling, injection site vesicles, injection site pruritus immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness sh... Read more
immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness she says. on questioning if BP was checked, she said BP was not checked. Denies ever getting lightheaded or dizziness with other types of vaccinations or immunizations so probable not vasovagal. Headaches she also reported arm aching at this vaccination site. initially said in 1/2 hour later she says 2 hours. She looked at the vaccination site on her arm for first time 8 hours after this vaccination. Found redness and blisters first time treated with diphenhydramine 5 mg. barely move arm next day. swelling arm lasted 2 days. photos of arm vaccination site she sent were reviewed. had video visit with Family Medicine Physician and later with video visit with Allergy Physician
27 2021-01-12 injection site pain Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fati... Read more
Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fatigue. Sore injection site, tender to the touch. Moments of Dizziness and zoning out.
27 2021-01-12 itchy skin, injection site redness, rash PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVI... Read more
PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVID CLINIC WHEN HER REACTIONS STARTED. SHE APPEARED FLUSHED, AND WAS DEVELOPING A RASH ON BOTH HER ARMS, ITCHING. HER INJECTION SITE WAS RED AS WELL AS THE SURROUNDING AREA, ABOUT 1INCH IN DIAMETER. SHE REPORTS NO DIFFICULTIES BREATHING, BUT SOUNDED LIKE SHE WAS BREATHING A LITTLE ON THE HEAVIER SIDE. SHE SAID THAT IT FEELS LIKE THE LOWER HALF OF HER THROAT IS A BIT BIG AND STARTING TO SWELL. SHE WAS WALKED TO ED BY ANOTHER NURSE. ED MD FELT THE INJECTION SITE WAS INFECTED. PATIENT RECEIVED ANTIBIOTICS AND BENADRYL FOR THE ITCHING.
27 2021-01-12 injection site rash, rash Rash on top of right thigh day after. Rash on left ankle and injection site 2 days after
27 2021-01-12 injection site pain Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection sit... Read more
Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection site, body chills, body aches and a fever of 102 F. Symptoms subsided after Motrin was administered (in about an additional 8 hours to recover fever). Body aches, pain at injection site and lingering headache still present 24 hours after vaccination.
27 2021-01-12 rash, shingles left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on n... Read more
left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine). The patient experienced face was numb on left side since 02Jan2021. The patient also experienced pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved. The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.
27 2021-01-12 rash rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is ... Read more
rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over; a lot of muscle pain; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 24Dec2020 09:30 at single dose for preventative. Medical history included none. There were no concomitant medications. The patient previously took influenza vaccine (FLU) for immunization and experienced sick (Flu shot if it contains egg she gets really sick). Patient reported experiencing a rash 2 weeks on 06Jan2021 after getting her first dose of the vaccine. Caller stated ''I'm concerned because I'm getting this rash on my face and everywhere and I'm due for my booster on 13Jan2021." Caller questioned if others had reported this. She had a lot of muscle pain on 24Dec2020 and could not sleep from the pain in Dec2020. Reports the pain is gone now and lasted till 28Dec2020. She has a rash and it is breaking out her face and now it is all over. States nothing has changed and the vaccine was the only new thing. States the rash started two weeks since she got the vaccine. Vaccination facility type was Hospital. Vaccine administered at military facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE not require a visit to emergency room. Therapeutic measures were taken as a result of rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over (Doctor ordered steroids for her today she is a CNA). The outcome of the event a lot of muscle pain was recovered on 28Dec2020. The outcome of the event rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over was not recovered. The outcome of the event could not sleep was unknown. Information about lot/batch has been requested.
27 2021-01-13 injection site pain After receiving my second dose of the Pfizer COVID-19 Vaccine on the morning of 1/13/21, I had arm s... Read more
After receiving my second dose of the Pfizer COVID-19 Vaccine on the morning of 1/13/21, I had arm soreness at the injection site. Later in the day, I experienced fatigue, which progressed to body chills and aches. Overnight, I developed a fever of 101.5 F. Fever was managed with ibuprofen taken throughout the following day, 1/13/21. On 1/13/21 at night, I had another fever of 101.6 F but did not taken any antipyretics before bed. On the morning 1/14/21 body aches, body chills, and fevers were resolved without antipyretics. Arm soreness still present on 1/14/21.
27 2021-01-13 hives Hives on chest, neck, and face, headache, diaphoresis five min after COVID vaccine A & O x4, ambulat... Read more
Hives on chest, neck, and face, headache, diaphoresis five min after COVID vaccine A & O x4, ambulates. Administered Benadryl 50mg PO. symptoms persist after 20min. Called 911, evaluated and transported to Emergency Dept.
27 2021-01-13 injection site pain My injection was at 4:08 pm on 1/13/21. I woke up from a dead sleep at 2:30am on 1/14/21 and starte... Read more
My injection was at 4:08 pm on 1/13/21. I woke up from a dead sleep at 2:30am on 1/14/21 and started vomiting for about 20-25 minutes. Also muscle pain at injection site.
27 2021-01-13 rash, itchy skin Patient reported having a rash/itching hands and feet about 2days after the vaccine. Took Benadryl 4... Read more
Patient reported having a rash/itching hands and feet about 2days after the vaccine. Took Benadryl 4 times a day and resolved two days later. was told to contact primary care physician before getting the second dose
27 2021-01-13 vaccination site pain injection site pain; This is a spontaneous report from a non-contactable pharmacist (patient). A 27-... Read more
injection site pain; This is a spontaneous report from a non-contactable pharmacist (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730, expiry: unknown), via an unspecified route of administration on 17Dec2020 12:00 at single dose (Left Arm) for COVID-19 immunization. Medical history reported as none. Patient had no known allergies. Patient is not pregnant. The patient's concomitant medications were not reported. Other medications within 2 weeks of vaccination was reported as oral contraceptives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Only adverse event related to first dose was injection site pain from an unspecified date. The outcome of the event was unknown. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
27 2021-01-13 vaccination site swelling, vaccination site redness redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; ... Read more
redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), via intramuscular route of administration on the left arm on 18Dec2020 17:15, then the second dose via an unspecified route of administration on the left arm on 07Jan2021, both at single dose for COVID-19 immunization administered at hospital facility. Medical history included asthma, anxiety, vitamin d deficiency, eczema and rosacea, and known allergies: nickel and latex. Concomitant medications included influenza vaccine (FLU) on 11Nov2020 received within 4 weeks prior to the COVID vaccine; minocycline, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, norgestrel (CRYSELLE), colecalciferol (VITAMIN D) , calcium, and vitamin b complex received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced redness and mild swelling at injection site, sore arm on 19Dec2020. The events were reported as non-serious and no treatment was given. The patient underwent COVID test/ nasal swab: negative on 24Nov2020. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
27 2021-01-14 injection site pain After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could n... Read more
After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp contacted employee heatl
27 2021-01-14 rash macular, itchy skin, redness After administering the first dose, patient became itchy and blotchy all over body. At 11:04am gav... Read more
After administering the first dose, patient became itchy and blotchy all over body. At 11:04am gave patient Benadryl 50mg. By 11:12am redness was going away.
27 2021-01-14 skin tightness Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pa... Read more
Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pain. Unable to life arm to dress next morning. Increasing pain, felt like a circulation problem - cold, numb, limp used ice and tylenol and aleve, day two slightly better
27 2021-01-14 hives hives after first shot; This is a spontaneous report from a non-contactable healthcare professional ... Read more
hives after first shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, via an unspecified route of administration, the first dose on 15Dec2020 (lot number: EH9899) at a single dose, then the second dose on 08Jan2021 (lot number: EK9231) at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient experienced hives after first shot on 15Dec2020. No treatment received. Outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.
27 2021-01-15 itchy skin Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, ... Read more
Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, medicated with Benadryl P.O., started with throat itching, medicated with Benadryl IM, EPI IM, EMS called, placed on O2, diminished breath sounds bases, slight stridor, EPI IM, Solumedrol IM, EMS transported to local ED. Patient called NP later in day and said she was admitted to the hospital.
27 2021-01-17 itchy skin, itchy rash Itchy hands and small rash on upper midline abdomen
27 2021-01-17 hives, itchy skin Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my ... Read more
Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.
27 2021-01-17 injection site swelling, itchy skin, redness Vaccination was on Wednesday: about a half hour after vaccine, I experiences increased heart rate, v... Read more
Vaccination was on Wednesday: about a half hour after vaccine, I experiences increased heart rate, vision going black like I was going to pass out, it passed in about 5-10minutes of laying down; also had metallic taste in mouth the rest of that day. Thursday I just felt red, itchy, swollen L arm due to vaccination site. Friday morning my bottom lip was severely swollen with numbness and tingling. It went down by the next day and after taking Benadryl. I have not had an allergic reaction to anything in my life before. Was instructed to not get second vaccine as I may have a more increased reaction to it.
27 2021-01-17 injection site bleeding, injection site mass When I went to get the shot, I had a firm bump with what looked like a white head on my left arm fr... Read more
When I went to get the shot, I had a firm bump with what looked like a white head on my left arm from the first shot. When she injected the 2nd dose, the bump was painful and grew twice in size on my arm and started bleeding. The technician rubbed the area for a fews minutes and the swelling went down. The bump went down, but the whole day, I felt a little sick. At around 7pm, I felt feverish, with muscle aches and chills. My skin was sensitive to touch, I felt nauseous, and I could barely walk. The bottom of my left eyelid also became a little swollen. The symptoms resolved the next morning.
27 2021-01-18 rash, rash maculo-papular About 10-15 minutes after vaccination, patient reported that she was feeling dizzy and was breaking ... Read more
About 10-15 minutes after vaccination, patient reported that she was feeling dizzy and was breaking out in a rash. Upon examination, a maculopapular rash was observed on upper chest and arms. No localized symptoms at injection site were reported. No breathing abnormality was reported. Patient was placed under further observation and vitals were taken by RN at facility (BP: ~113/100, HR: 105). Patient was observed for another 15 minutes, patient reported her dizziness was still present, rash was not worse at this time. No breathing abnormality was reported at this time either. Medical services (which were called for a different patient) also evaluated this patient and the patient was then taken to local ED for further evaluation.
27 2021-01-18 injection site swelling, injection site pain, injection site redness, injection site warmth Arm pit sore - to injection site, warm to touch, red area, tender to touch, swollen denies any fever... Read more
Arm pit sore - to injection site, warm to touch, red area, tender to touch, swollen denies any fever Started on abx - cephalexin
27 2021-01-18 injection site hives Fifteen minutes following injection, the left arm broke out in hives and had numbness and tingling. ... Read more
Fifteen minutes following injection, the left arm broke out in hives and had numbness and tingling. Then I became dizzy and pale. I was laid down and vital signs were taken. My heart rate was in the 110s and 120s and stayed elevated for about four hours. The hives resolved and did not spread to the bilateral arm or anywhere else. The following two days I felt incredibly weak and had urinary frequency. I was told to go to the hospital by the health clinic staff but I declined.
27 2021-01-18 injection site redness, injection site pain, injection site pruritus, injection site warmth Large red circle around injection site, hot, itchy, painful that continues to expand even at day 4
27 2021-01-18 injection site redness Significant arm soreness, limited muscle rotation for 3 days. Redness around injection site and redn... Read more
Significant arm soreness, limited muscle rotation for 3 days. Redness around injection site and redness of bandaid mark 3 days later with multiple washes.
27 2021-01-18 vaccination site swelling injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weak... Read more
injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.
27 2021-01-18 vaccination site pain tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report fr... Read more
tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report from a non-contactable other healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration (left arm) on 01Jan2021 10:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that immediately after receiving vaccine (01Jan2021), the patient felt tingle in throat, severe left arm pain, dizziness, weakness, and migraine. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible. No further information is expected.
27 2021-01-19 skin warm 1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning ... Read more
1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning to go to a 30 min obs seat. Did not strike head, sat on buttocks and propped self with left arm; No medical Hx. BP 140/100 P 96 R 12 SpO2 100%; LOC A&O x3, did not lose consciousness; skin warm pink and sweaty; hot at back of neck; HR regular; Resps unlabored; Lungs clear; assisted to a supine on floor and legs elevated; ice pack for comfort; EMS notified 1420 BP 152/104 P 70 R 12 SpO2 99% Resps continued unlabored; EMS arrived; Handoff report given; EMS assessed; client sitting; ; client offered transport to local ED and declined 1430 Client moved back into chair; BP 136/94 P 94 R 12 SpO2 99% 1440 Client stated she was starting to feel light headed again. Moved to floor and legs elevated again. BP 140/90 P 87 R10; Resps unlabored; A&O x3; skin cool pink dry; 1445 BP 136/108 P 85 R 10 ; continues supine with legs elevated; requested that client find someone to drive her home rather than drive self; client contacting boyfriend 1450 BP 140/108 Client states she feels fine but would like to remain on the floor sitting up. 1500 Client moved to chair for further observation; VS assessment discontinued 1530 Client remains in obs and waiting for ride
27 2021-01-19 hives, rash I had side effects (fevers, myalgias, headaches) the day after. However, starting Saturday 1/9 I beg... Read more
I had side effects (fevers, myalgias, headaches) the day after. However, starting Saturday 1/9 I began having urticaria all over my body. I took Benadryl 4 times over the course of the day, and the rash goes away but comes back. Went to Urgent Care on Sunday. Advised to take Benadryl and Pepcid
27 2021-01-19 itchy skin Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizz... Read more
Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizzy. Had patient lay down, monitored VS every 10 minutes. 1750 - BP 114/70, P 85, R18, O2 100 1800 BP 127/65, P78, R16, O2 100. Drinking water. After 10 minutes heart rate felt better but c/o itching, flushed chest. Gave oral Benadryl 25mg liquid. VS 1810 BP 120/67, P 70, R 16, O2 100%. VS at 1830 BP 115/61, P70, R 15, O2100%
27 2021-01-20 rash 30 minutes after vaccine pt developed rash on arms and had tingling in right arm. No other symptoms... Read more
30 minutes after vaccine pt developed rash on arms and had tingling in right arm. No other symptoms. Gave 1 dose of 50mg benedryl and within 15 minutes the tingling had stopped and the rash went down. Monitored for 30 minutes and the pt was then released.
27 2021-01-20 rash Chills, fever, body aches, headache started about 12 hours after injection. About 24 hours after inj... Read more
Chills, fever, body aches, headache started about 12 hours after injection. About 24 hours after injection I developed a rash and swollen lymph nodes on the arm the shot was given to me
27 2021-01-20 vaccination site pain Fever (103 lasting a day and a half); Nausea; Chills; Muscle aches and soreness; Malaise; Lymphadeno... Read more
Fever (103 lasting a day and a half); Nausea; Chills; Muscle aches and soreness; Malaise; Lymphadenopathy; Arm/under arm/pec soreness in vaccine arm; Fatigue; Sore throat; Dry cough; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 07Jan2021 07:45 at single dose in left arm for covid-19 immunization. The patient had no medical history and no known allergies. Concomitant medication in two weeks included birth control. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 21Dec2020 10:15 at single dose in left arm for covid-19 immunization. The patient had no other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough on 07Jan2021 19:00. The patient did not receive any treatment for these events. The outcome of the events fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough was recovered in Jan2021. Information on the lot/batch number has been requested.
27 2021-01-20 injection site reaction First started off with a cold feeling around injection site. Around 11:30 at night I felt muscle ach... Read more
First started off with a cold feeling around injection site. Around 11:30 at night I felt muscle aches in my calves. 30 minutes later my legs were having severe muscle aches and joint pain in my ankles. I was having cold chills and aches the whole night along with sweating. On 1/20/2021 (the next day) the muscle aches, chills, and joint pain continued through the whole day. I was nauseous at times and did not have an appetite. Around 5 o clock I felt some relief with my leg pain but it started again around 9 o clock. I continued switching Tylenol extra strength and ibuprofen. I went to bed on 1/20 at midnight with little leg pain but major neck and back aches. I did not have cold chills through the night or sweating. Today (1/21/2021) leg pain is near gone, but joint pain is still there in my left ankle and knee. My legs feel heavy and strange and is causing me to walk slowly because I feel like my legs are very fatigued and off balance. I have had neck and back aches all day. I have not had chills today
27 2021-01-20 injection site pain, injection site swelling I was asymptomatic for about 6.5 hours after the vaccine was given. At about 6pm on the day I receiv... Read more
I was asymptomatic for about 6.5 hours after the vaccine was given. At about 6pm on the day I received the vaccine I noticed some injection site tenderness, minimal swelling; has been present since. Symptoms are very mild. I started having chills and hot flashes intermittently, more hot flashes than chills, have been present since 6pm yesterday. About 9pm I had a headache, muscle aches, joint pain as well. I felt feverish but temperature was 98.6F. I also noticed some axial lymph node swelling as well on the Left side where I received the vaccine. Tender to touch, not too painful though. Since received the vaccine I have had intermittent dizzy spells as well all throughout the day. I decided to go to sleep at 10:30pm and all night I tossed and turned with a headache and hot flashes. I woke up at 7:30am and was so stiff I could barely get out of bed. I called into work as I could not stand up without have dizziness. All day so far I have had dizziness upon standing, headache, myalgia, arthralgias, hot flashes/felt feverish, swollen axial lymph nodes and all I have wanted to do today is sleep. I took a nap and when I woke up I had been sleeping for 6 hours. I finally was able to get up and drink a 32ounce cup of water and take some ibuprofen. Ate some cereal. I still have a headache and dizziness upon standing that limit my ability to do normal daily functions.
27 2021-01-20 injection site inflammation Patient reported swelling of lymph nodes in armpit, inflamed injections site, pain. Recommended ici... Read more
Patient reported swelling of lymph nodes in armpit, inflamed injections site, pain. Recommended icing the area, take diphenhydramine and some Tylenol and/or ibuprofen for pain and inflammation.
27 2021-01-20 rash Rash on upper body; This is a spontaneous report from a contactable healthcare professional (patient... Read more
Rash on upper body; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2, intramuscularly in right arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were unspecified. On 10Jan2021 15:00, patient experienced rash on upper body. Treatment was not received for this event. Outcome of the event was unknown. Information on the lot/batch number has been requested.
27 2021-01-21 redness, hives Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10... Read more
Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10 minutes after vaccine- cough, shortness of breath, tongue itchy, lips swelling. Epi pen in L thigh, 50 mg benedryl IM in R deltoid. Brought to emergency room, 1 liter normal saline, pepcid, solu-medrol, 25mg benadryl IV. D/c to home around noon. 1/22/2020- secondary anaphylactic reaction at 945am. Epi pen to r thigh, 50mg PO benadryl, 20mg prednisone. Drove to hospital ER received 1 liter of normal saline, pepcid, 25mg benadryl IV, 40mg prednisone. D/C at 3pm on prednisone taper.
27 2021-01-21 rash Patient developed diffuse rash on 01/20/2021, 2 weeks after COVID-19 vaccine administered on 0/06/20... Read more
Patient developed diffuse rash on 01/20/2021, 2 weeks after COVID-19 vaccine administered on 0/06/2021. Rash erythematous and raised with no hives. Rash started on chest and has spread to bilateral arms, bilateral legs, and back. Face, palms, and soles spared. Reports cough and shortness of breath for an hour when rash first appeared that resolved and has no returned. Since rash has started has taken OTC Benadryl every 6-8 hours. Patient presented on 01/22/2021 for evaluation of the rash.
27 2021-01-21 rash, itchy rash Patient received vaccine on 01/06/2021 and developed a diffuse rash on 01/20/2021. Rash started on t... Read more
Patient received vaccine on 01/06/2021 and developed a diffuse rash on 01/20/2021. Rash started on the chest and then spread to the bilateral arms, bilateral legs, and her back. Her face, palms, and soles are spared. Rash is mildly pruritic and not painful. Patient reports at the time the rash started she had a cough and SOB for 1 hour that has resolved and not returned. Patient has been taken OTC Benadryl PRN every 6-8 hours since the rash presented. Patient presented to Clinic for evaluation on 01/22/2021.
27 2021-01-21 redness, itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA: Approximately three days after vaccine administration patient ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Approximately three days after vaccine administration patient developed itching and redness of face and body. Went to urgent care and prescribed hydroxyzine which patient took and immediately relieved symptoms. No other medications administered and no other symptoms reported.
27 2021-01-21 shingles Shingles on my face and in eye
27 2021-01-21 injection site pain, injection site hardening, injection site swelling hard and painful bump on and around the injection site.
27 2021-01-22 injection site pain Fatigue, dizziness, pain at injection site, muscle pain
27 2021-01-22 injection site rash, injection site pruritus Had itching at site immediately rash above site developed later in the day. About 10 minutes after i... Read more
Had itching at site immediately rash above site developed later in the day. About 10 minutes after injection developed nausea then felt very hot became clammy and sweaty. Felt lightheaded became pale had to played down on the ground.
27 2021-01-22 injection site pain, hives, rash, itchy skin, redness I received my vaccine yesterday. I waited at the location for 15 minutes with no issues. After about... Read more
I received my vaccine yesterday. I waited at the location for 15 minutes with no issues. After about 20 minutes, I developed a burning sensation at the injection site. Approximately 30 minutes following the vaccine, I began experiencing an intense itching and hives of my opposite forearm. Then shortly after, my shins and front of ankles started itching. I began getting little bumps with an itch to several other areas of my body, also including redness and itchiness of one side of my face. At about 40 minutes, I also experienced a cold sensation felt at the injection site, almost like what it feels like after removing an ice cube from the skin. The itching of my skin on several areas of my body persisted for about an hour and a half. The welts and itchiness almost completely subsided at about the 2 hour mark. I did take two benedryls once I got home which was about an hour and a half after the injection. Today, the following day after injection, the bumps and itchiness are still no longer present. I have been experiencing a very sore arm at injection site and extreme exhaustion today though.
27 2021-01-22 injection site warmth, injection site redness, rash, injection site hardening, injection site swelling Within 5-10 minutes of receiving the vaccine my heart starting racing a little bit, I got a little l... Read more
Within 5-10 minutes of receiving the vaccine my heart starting racing a little bit, I got a little light headed, and had a weird taste in my mouth. The morning after my vaccine (1/22/2021) the Injection site of the vaccine is swollen, hot to the touch, and red/hard. The following day (1/22/2021) around 3:45 pm I broke out in a rash on my face and neck
27 2021-01-23 injection site pain Pain at site, headache, chills, fever 102, muscle and body aches
27 2021-01-24 injection site redness, injection site swelling Nausea (2-3 days) Constant headache Swelling in injection site Redness at injection site Feeling ... Read more
Nausea (2-3 days) Constant headache Swelling in injection site Redness at injection site Feeling unwell
27 2021-01-24 rash with redness, rash Raised red rash covering upper, lower trunk, back, stomache and legs.
27 2021-01-24 injection site pain Two hours after the vaccine was given, I developed a headache and the injection site was sore. I tre... Read more
Two hours after the vaccine was given, I developed a headache and the injection site was sore. I treated it with ibuprofen. Approximately 48 hours after the vaccine was given, I experienced a sore throat and fatigue that has lasted for two days and counting.
27 2021-01-25 itchy skin Warm sensation all over and itching 25 minutes after vaccine given
27 2021-01-26 rash Bilateral forearm bumps/rash
27 2021-01-26 vaccination site pain Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at i... Read more
Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021. Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.
27 2021-01-26 rash macular, rash with redness, itchy skin Red rash on my face about 24 hours after initial dose- went away with Benadryl Rash was itchy and b... Read more
Red rash on my face about 24 hours after initial dose- went away with Benadryl Rash was itchy and blotchy
27 2021-01-26 hair loss sweating; chills; fever; major fatigue; Major hair loss starting 1.5 days following the vaccination;... Read more
sweating; chills; fever; major fatigue; Major hair loss starting 1.5 days following the vaccination; This is a spontaneous report from a contactable other health care professional. A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 12Jan2021 16:30 at SINGLE DOSE at Arm Left for covid-19 immunisation. Medical history included covid-19; covid prior vaccination: yes. Concomitant medication included escitalopram oxalate (LEXAPRO). Major hair loss starting 1.5 days following the vaccination on an unspecified date in Jan2021, in addition to sweating, chills, fever, and major fatigue on 13Jan2021 22:30. The patient did not receive treatment for the events. The outcome of the events was not recovered.
27 2021-01-27 redness Previously enlarged lymph node (after first COVID 19 vaccine) became larger and red for 3 days. It t... Read more
Previously enlarged lymph node (after first COVID 19 vaccine) became larger and red for 3 days. It then went back down to the size it was after the first injection.
27 2021-01-27 shingles Reported back pain, headache, nausea and treated for shingles. PCP prescribed Valtrex
27 2021-01-27 injection site swelling, vaccination site redness, vaccination site pain, vaccination site itchiness, vaccination site warmth swelling at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness... Read more
swelling at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; body aches; fatigue; fever 100.2; This is a spontaneous report from a contactable Nurse. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), intramuscular on 13Jan2021 10:45 at single dose for covid-19 immunisation. Vaccine location was left arm. Medical history included covid-19. Historical vaccine included first dose of BNT162B2 lot number EK5730 on 22Dec2020 10:15 AM. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), cetirizine hydrochloride (ZYRTEC). The patient experienced body aches on 14Jan2021 05:00, fatigue on 14Jan2021 05:00, fever 100.2 on 14Jan2021 05:00, pain, itching, redness, warmth at injection site on 15Jan2021. The patient underwent lab tests and procedures which included body temperature: 100.2 on 14Jan2021, and 99.8 on 15Jan2021. No treatment received. The events recovered in Jan2021.
27 2021-01-28 injection site redness, injection site swelling Local skin allergic reaction at the injection site; Swelling (about the size of a quarter) at the in... Read more
Local skin allergic reaction at the injection site; Swelling (about the size of a quarter) at the injection site; Red dots (about the size of a pencil eraser) that appeared around the injection site; some spots around the area approximately the size of pencil erasers; This is a spontaneous report from a contactable pharmacist (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), intramuscular in the left upper deltoid muscle, on 13Jan2021 at 10:30, at a single dose, for COVID-19 vaccination. The patient had no medical history and concomitant medications. On 13Jan2021, the patient received first dose of vaccine and immediately (about 5 minutes after she received the vaccine at 10:35) developed non-severe local skin allergic reaction and swelling at the injection site, and some spots around the area approximately the size of pencil erasers. The patient had swelling (about the size of a quarter) at the injection site, along with red dots (about the size of a pencil eraser) that appeared around the injection site. The patient's vital signs were normal, her breathing was fine, and she had no swelling in her throat or lips. The patient took diphenhydramine hydrochloride (BENADRYL) 25 mg tablet, and a minute or two after taking the diphenhydramine hydrochloride tablet, all the symptoms went away. The patient was calling to see if she should receive the second dose of the vaccine. The patient asked if she should get the second COVID-19 vaccine dose, based on her adverse reactions after receiving the first dose. The patient recovered from the events on 13Jan2021.
27 2021-01-29 redness While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling... Read more
While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling, and tingling of tongue and lips. Redness was in face, chest and right arm. Client denied difficulty breathing or throat tightness. Client reported at this time "significant hx of anaphylactic reaction." This was not noted clearly on screening form signed by client. Client given 50 mg Benadryl per standing order due to symptoms. Epinephrine was not given. 911 was called. Client vitals remained stable with slightly elevated blood pressure ate 140/102. EMS arrived before repeat vitals were taken. Lung sounds were clear and equal bilaterally. Report was given to EMS and care transferred.
27 2021-01-30 injection site pain Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as ... Read more
Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as time passed, started hot flashes , cold flashes and shakes around 11am, right kidney (?) area on back started to hurt around 11:30am pain increasing as well. All persistent until about 5:30pm where the kidney (?) pain subdued followed by the hot and cold flashes around 7pm. Nausea and shakes passed by 1/30/21 am after I woke up. Full Left arm pain continued all day 1/30/21.
27 2021-01-30 rash c/o rash, throat felt "weird", lips felt "tingly"
27 2021-01-31 injection site redness ?Pfizer-BioNTech COVID-19 Vaccine EUA? Pt had red streaking to arm near injection site approximatel... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? Pt had red streaking to arm near injection site approximately 10 minutes after injection, then also had chest tightness and felt like her voice had changed. Was given 50mg of benadryl by EMS with near immediate improvement of her symptoms but pt referred to ED. Pt arrived at ED and felt improved, no redness noted to site, no hives or rash noted on exam. Discharged home
27 2021-01-31 hives, itchy skin, injection site pruritus, rash I started breaking out in hives/rash on January 27th at church. I was itching all over. I took a ben... Read more
I started breaking out in hives/rash on January 27th at church. I was itching all over. I took a benadryl to help. Since then I have continued to break out in spurts. The site will start itching on my body and not stop until I itch it, then it goes away and pops up somewhere else. I have not changed laundry detergent, eating habits or environments. The only thing new to me would be the vaccine. with it being almost 8 days onset from vaccine, I didn't think that would be the problem. I can't figure it out though. I spoke with Doctor this morning and she said it was best to report because it could be an adverse reaction.
27 2021-01-31 rash, dry skin, rash papular Patient sitting in chair of observation area. Suddenly felt dizzy. Observation staff RN brought pa... Read more
Patient sitting in chair of observation area. Suddenly felt dizzy. Observation staff RN brought patient to triage. Patient states she felt dizzy. Lightheaded, nauseated, started vomiting, vomited two times. Slightly diaphoretic. She is warm and dry BP elevated. Patient started to scratch back, lower and mid back. noted with scattered raised red rash. Patient drowsy and altered mental state gave Benadryl. Patient to triage cot, cold pack applied V.S and N.S. measured. Charge nurse present. Benadryl 50mg IM given per protocol. EMS activated. report given to paramedic crew. No further vomiting. V.S.S. SR on monitor O2 sat 99%. Remains orientated to name, place and date. Cannot open her phone or recall family emergency number. Patient sent to hospital with EMS.
27 2021-01-31 skin burning sensation Skin feels like she rubbed icy hot all over her body /it feel like her face is on fire /She felt lik... Read more
Skin feels like she rubbed icy hot all over her body /it feel like her face is on fire /She felt like she was running a fever but was not. She was hot and cold during the night; it burns; felt hot and cold; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 17Jan2021 at single dose at left arm for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. On 17Jan2021, the patient experienced skin feels like she rubbed icy hot all over her body, like if she scratched or touch it, it burns. There is no redness or rash. Her work just sent her home because she is required to wear an N95 mask. Her breath against the mask makes it feel like her face is on fire and she cannot wear it. She felt like she was running a fever but was not. She was hot and cold during the night, but her temperature was 98 degrees Fahrenheit. She just took Benadryl and they sent her home. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination. Information on lot/batch number has been requested.
27 2021-01-31 vaccination site redness, vaccination site pain, vaccination site swelling two inches of redness and swelling at the injection site that is tender to touch; two inches of redn... Read more
two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 13Jan2021 at 16:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was reported as none. The patient has no known allergies. Concomitant medication included topiramate (TOPAMAX). The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient had two inches of redness and swelling at the injection site that is tender to touch. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was unknown. Information on the lot/batch number has been requested.
27 2021-01-31 injection site bleeding vaccine administration error- left deltoid injection site bleeding moderately immediately following ... Read more
vaccine administration error- left deltoid injection site bleeding moderately immediately following administration, the bleeding stopped with approx 30 seconds of pressure to site. No other adverse reactions. Evaluated by the medical provider at the site and injection appeared to be in the correct area.
27 2021-02-01 itchy skin, hives All over body hives with severe itchiness, medicated with Benadryl, took 2 doses of Benadryl and sti... Read more
All over body hives with severe itchiness, medicated with Benadryl, took 2 doses of Benadryl and still feeling itchiness and hives. Symptoms started around 10 am and lasted all day
27 2021-02-01 rash Moderate rash for 24 hours, headache for 24 hours and fever for 48 hours along with nausea, addition... Read more
Moderate rash for 24 hours, headache for 24 hours and fever for 48 hours along with nausea, additional notes not sure if rash is due to shrimp allergy
27 2021-02-01 itchy skin the patient felt itchy; flushed; This is a spontaneous report from a contactable pharmacist. A 27-y... Read more
the patient felt itchy; flushed; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 10Jan2021 at single dose for COVID-19 immunization; and diphenhydramine hcl, via an unspecified route of administration from an unspecified date at unknown dose for premedication. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously had first dose of BNT162B2, lot number: EL0140, via intramuscular in left arm on 20Dec2020 at single dose for COVID-19 immunization and experienced itching. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was pre-medicated with diphenhydramine prior to the second dose of the COVID-19 vaccine. 9 minutes after the vaccination on 10Jan2021, the patient felt itchy and flushed then received oral dexamethasone as treatment for the events. The patient was sent out with oral dexamethasone home. The outcome of the events was recovering. The action taken in response to diphenhydramine hcl for the events was unknown.
27 2021-02-02 itchy skin, hives severe itchiness to upper body hives
27 2021-02-03 hives Dermatographia, hives with pressure. Benadryl. Still happening two weeks later
27 2021-02-03 vaccination site pain, vaccination site redness, vaccination site swelling Fever 99.9; body aches; Injection site tenderness, swelling, redness x 10 days; Injection site tende... Read more
Fever 99.9; body aches; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration at left arm, on 22Dec2020 10:15 at single dose for covid-19 immunisation. Medical history included having COVID prior vaccination. Patient has no known allergies. Patient is not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), vitamins nos (MULTIVITAMIN). Patient did not receive other vaccine in four weeks. Patient experienced fever 99.9, body aches, Injection site tenderness, swelling, redness x 10 days, all on 23Dec2020 08:00. No treatment received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered.
27 2021-02-03 redness Scattered Diffuse erythematous plaques ~ 5 days after receiving second Pfizer vaccine + with syste... Read more
Scattered Diffuse erythematous plaques ~ 5 days after receiving second Pfizer vaccine + with systemic body aches. Treated with topic steroid and PO steroids
27 2021-02-04 hives, itchy skin Hives all over body, itchy all over body, fever
27 2021-02-04 vaccination site pain Pain at injection site; muscle pain; fatigue; dizziness; This is a spontaneous report from a contact... Read more
Pain at injection site; muscle pain; fatigue; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient (unknown if pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on left arm on 23Jan2021 13:15 at single dose for covid-19 immunisation. Medical history included Migraines with aura, vasovagal syncope, PCOS, environmental allergies/hay fever, eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cefixime (FLEXERIL), ibuprofen (ADVIL), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), inositol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain at injection site, muscle pain, fatigue, dizziness, all on 23Jan2021 1400. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.
27 2021-02-04 redness, injection site swelling The next day following the vaccine, I experienced muscle aches, headache, fatigue, febrile temp bef... Read more
The next day following the vaccine, I experienced muscle aches, headache, fatigue, febrile temp before taking antifebrile medication at 100.8 F. At the site of injection on my left arm there was a red mark and slight swelling, left arm felt weak and sore. Overall sense of unwell lasted for two days.
27 2021-02-05 skin warm, redness Client upper arms flush red and chest. Is complaining of feeling warm and headache. EMS evaluated B... Read more
Client upper arms flush red and chest. Is complaining of feeling warm and headache. EMS evaluated Bp122/90, lung sounds clear. Instructed to either see PCP or go to ER. Client called Dermatologist and showed her doctor her chest in between EMS check. Derm. doctor instructed her to take benadryl Client to be driven home by family. Instructed if does not improve with benadryl to go to ER.
27 2021-02-05 injection site pruritus Muscle sore and itchy around injection site. No redness. EMS evaluated and removed band aid. Had ... Read more
Muscle sore and itchy around injection site. No redness. EMS evaluated and removed band aid. Had client do arm stretching exercised and felt better.. BP 120/82 P72 O2 98% lung sounds clear
27 2021-02-06 injection site reaction Mild site reaction, chills and fever
27 2021-02-06 redness Tingling beginning at thumb and pointer finger, progress to forearm and upper arm over 3 days. Swell... Read more
Tingling beginning at thumb and pointer finger, progress to forearm and upper arm over 3 days. Swelling began near elbow, redness and pain followed and immobility. Visited ER on 2/3/21 and diagnosed with superficial thrombophlebitis
27 2021-02-07 vaccination site pain After second dose pain at injection site; chills; diarrhea; GI upset; unwell feeling; This is a spon... Read more
After second dose pain at injection site; chills; diarrhea; GI upset; unwell feeling; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration left arm, on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. No reported allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered as at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient is not pregnant at vaccination time. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 on the left arm. The patient experienced after second dose, pain at injection site, chills, diarrhea, GI upset, and unwell feeling on 20Jan2021 21:00. No treatment was given for the events. Outcome of the events was unknown. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
27 2021-02-07 itchy skin Left eye is swollen and the left side of her neck and left shoulder feel itchy Took oral Benadyrl
27 2021-02-07 rash Rash on inside of elbow on same arm as injection; This is a spontaneous report from a non-contactabl... Read more
Rash on inside of elbow on same arm as injection; This is a spontaneous report from a non-contactable consumer report for self. This 27-year-old not pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm on 20Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced rash on inside of elbow on same arm as injection on 22Jan2021. Event recovered on 24Jan2021. No follow-up attempts are possible. No further information is expected.
27 2021-02-07 injection site redness Within an hour, I was having severe pain in my shoulder. I took off the bandaid and noticed the inje... Read more
Within an hour, I was having severe pain in my shoulder. I took off the bandaid and noticed the injection point was way higher than it should have been. I had redness in the area (about 1-1.5 inch diameter) too that I have a picture of to show the injection location. I have limited range of motion, severe pain, and shooting pain down the back of my arm. I am unable to use my arm or lift anything that has any weight to it.
27 2021-02-08 hives Hives on arms, appeared 10 minutes after injection. No breathing issues. Dosed two 25mg diphenhydram... Read more
Hives on arms, appeared 10 minutes after injection. No breathing issues. Dosed two 25mg diphenhydramine capsules. Pt had no hives 1 hour later. Told to follow up with emergency department if hives returned
27 2021-02-09 rash, itchy skin Patient stated that had an itchy throat and developed a rash through the body. She also reported it... Read more
Patient stated that had an itchy throat and developed a rash through the body. She also reported itchiness through the body.
27 2021-02-09 rash Rash to face started 2/9/21 evening incontinence of urine, 2/9/21 overnight nausea, stomach pain 2... Read more
Rash to face started 2/9/21 evening incontinence of urine, 2/9/21 overnight nausea, stomach pain 2/8/21 daytime/afternoon
27 2021-02-09 itchy skin Very intense itching all over the top of my scalp; This is a spontaneous report from a contactable c... Read more
Very intense itching all over the top of my scalp; This is a spontaneous report from a contactable consumer reporting for self. This 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) on 20Jan2021 at 9 O'clock in the morning at single dose for COVID-19 immunization. Medical history included anxiety depression. Concomitant medication included escitalopram oxalate (LEXAPRO) for anxiety depression. The patient previously received oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) and experienced intense itching. The patient experienced very intense itching all over the top of her scalp for about an hour (as reported) on 20Jan2021 at 2 O'clock in the afternoon. Patient did not receive any treatment, it did go away on it's own, and only lasted about 2 hours (as reported). The outcome of event was recovered on 20Jan2021.
27 2021-02-09 itchy skin, rash first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles... Read more
first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day. was diagnosed with modified bells paulsey. with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb. FaceTime with the INT to gather this info
27 2021-02-10 itchy skin She reported having profuse itching all over her body. No hives noted.
27 2021-02-10 rash Three days after both doses of the Pfizer Covid 19 vaccine, I experienced hand pain throughout the n... Read more
Three days after both doses of the Pfizer Covid 19 vaccine, I experienced hand pain throughout the night that traveled up my forearms. On a scale from 1-10 the pain was about a 7. After the first dose, the pain went away in the morning and I was fine. On the third day after the second dose, I woke up with a rash all over my body and again had pain throughout the night only this time I woke up with swollen hands. It?s now been two weeks since my second dose and I am still experiencing hand pain, though improving. My hands feel sore and tight.
27 2021-02-11 redness, itchy skin Facial redness, and itching
27 2021-02-13 hives Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephri... Read more
Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephrine drip, receiving three epinephrine injections and Benadryl from EMS. Likely will be kept for observation given epi drip.
27 2021-02-14 injection site pain 8/10 pain at the injection cite. Started 12 hours following the vaccine administration and resolved ... Read more
8/10 pain at the injection cite. Started 12 hours following the vaccine administration and resolved around 24 hours following administration of the vaccine.
27 2021-02-14 hives hives, within 30 minutes of injecton, given benadryl 25mg every 6 hours, pt went to home
27 2021-02-15 rash 3:30 Rash w/ 25mg of Benadryl. Director of nurses observed rash; Observed til 4:30 - reviewed with... Read more
3:30 Rash w/ 25mg of Benadryl. Director of nurses observed rash; Observed til 4:30 - reviewed with director of nurses - was fine to go home
27 2021-02-15 skin irritation, sensitive skin Skin sensitivity that feels like a sunburn from elbow to middle of back (covering the shoulder blade... Read more
Skin sensitivity that feels like a sunburn from elbow to middle of back (covering the shoulder blade on the side where the vaccine was injected). Painful sunburn sensation for the first day or two after presentation, but has lessened to more of an irritation 11 days later. Definitely still present though. No visible rash or marks.
27 2021-02-18 blister Patient had onset of blistering to ears, armpits, back of legs and groin. Patient decided to not ge... Read more
Patient had onset of blistering to ears, armpits, back of legs and groin. Patient decided to not get 2nd dose after reaction to 1st dose.
27 2021-02-21 shingles, rash vesicular, rash 8 days post completion of the COVID-19 Pfizer 2 vaccine series, herpes zoster (shingles) outbreak be... Read more
8 days post completion of the COVID-19 Pfizer 2 vaccine series, herpes zoster (shingles) outbreak began on the left forehead with ocular migraine and hypersensitivity of the left medial portion of the face. Valacyclovir 1000mg TID x10 days was initiated within 24 hours of onset, and rash continued to progress down the face to the left eyebrow, left nostril, and left upper lip. Pain and hypersensitivity of the left upper jaw and teeth began on day 3 of zoster outbreak, and ocular migraine increased in intensity. The rash began to blister on day 4, and is continuing to blister and weep currently (day 5).
27 2021-02-21 injection site pain Climbing Fever starting around 9:00 pm with current temp of 102.2 as of 10:50 pm (body temperature u... Read more
Climbing Fever starting around 9:00 pm with current temp of 102.2 as of 10:50 pm (body temperature usually <97). Severe chills onset around 9:30 pm. Mild Soreness at injection site starting approximately two hours after vaccination.
27 2021-02-21 rash Generalized Rash
27 2021-02-21 itchy skin, rash Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 2... Read more
Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 20, Administer Epi injector right thigh. Given IM Benadryl. Transported to ER.
27 2021-02-23 rash, itchy rash, rash with redness, rash maculo-papular Rash appeared on the trunk, small red maculopapular spots, bright red in color, slightly itchy, wit... Read more
Rash appeared on the trunk, small red maculopapular spots, bright red in color, slightly itchy, with clusters of a few at each spot. Majority of the spots appears within the bra line of the patient, started about a week and a half after the first done (1/22/21) but became increasingly worse two days after the second dose (was received on 2/12/21). First there were many more on the trunk with some patches increasing in size and rash starting to appear on arms and legs as well. Tried benadryl, fexofenadine, and hydrocortisone which helped minorly. Sought medical advice in the clinic (5 days post second dose) and couldn't identify other source of rash (no new product, no bugs bites, etc). Was prescribed triamcinilone acetate cream to help relive itching and redness, which as of 2/24/2021 is improving slowly.
27 2021-02-23 itchy skin Swollen lymph node and itching
27 2021-02-24 itchy rash I have an itchy rash all over my body; little white bumps; This is a spontaneous report received fro... Read more
I have an itchy rash all over my body; little white bumps; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient (not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number; E19269) via an unspecified route of administration on right arm on 03Feb2021 18:30, at single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included unspecified birth control within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she had an itchy rash all over her body, they were little white bumps on 04Feb2021. The patient was not received any treatment for the events. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Seriousness of the events was assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.
27 2021-02-24 injection site swelling, injection site pain I received the 2nd dose of the Pfizer COVID-19 vaccine around 9:15 am on 2/23/21. Initially, my only... Read more
I received the 2nd dose of the Pfizer COVID-19 vaccine around 9:15 am on 2/23/21. Initially, my only symptoms were injection site soreness and minor swelling. Gradually throughout the day, my entire left arm become more and more sore. By 5:00pm, I felt exhausted and dizzy and was having chills. My temperature was 99.8 degrees Fahrenheit. I took a dose of Extra Strength Tylenol, but felt no change. My joints and muscles began to ache around 6:00pm on 2/23/21 and did not stop aching until around 9:00pm on 2/24/21. During the evening of 2/23/21, my dizziness increased and I felt as if I would pass out any time I sat up or stood. My temperature had returned to 98.2 degrees Fahrenheit by 10:00pm on 2/23/21. I then took a dose of Motrin to help with my soreness. On 2/24/21 from morning until 8:30pm, I had no fever or chills, but still felt exhausted and had minor muscle/joint achiness. I took 3 doses of Motrin on 2/24/21 to help with the soreness. Throughout the day, I had some difficulty breathing (felt like a mild asthma attack) and used my emergency inhaler once. At 8:30pm on 2/24/21, my temperature was 100.5 degrees Fahrenheit. I took another dose of Motrin and went to sleep. Around 3:00am on 2/25/21, I woke up drenched in sweat, but feeling better. My temperature was normal then. When I woke up at 7:00am on 2/25/21, I no longer felt achy, dizzy, or tired. I still feel (now at 1:30pm on 2/25/21)as though my asthma is aggravated, but am not having difficulty breathing.
27 2021-02-25 sensitive skin Dermal Hypersensitivity after 1st dose on1/21/2021. It got better and then I had the 2nd dose on 2/1... Read more
Dermal Hypersensitivity after 1st dose on1/21/2021. It got better and then I had the 2nd dose on 2/14/2021 and it is back
27 2021-02-25 vaccination site itchiness, vaccination site rash Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freez... Read more
Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.
27 2021-02-25 itchy skin, redness anaphylactic like reaction immediate flushing, redness, itching, disseminated, irregular breathing, ... Read more
anaphylactic like reaction immediate flushing, redness, itching, disseminated, irregular breathing, nausea, dizziness,
27 2021-02-26 injection site redness, injection site pain, injection site pruritus Persistent and painful lymphadenopathy in left armpit that started T+36 hours after vaccination. At ... Read more
Persistent and painful lymphadenopathy in left armpit that started T+36 hours after vaccination. At 7 days after administration of the vaccine, lymphadenopathy in left armpit persists and remains painful. At 7 days post vaccination a 2 inch patch of swollen skin appeared at the injection site. This is accompanied by redness, itchiness, and pain.
27 2021-02-27 injection site pain, rash, itchy skin Fatigue - 4 PM - 02/26/2021-Present Nausea - 5 PM - 02/26/2021-Present Headache - 5 PM - 02/26/2021-... Read more
Fatigue - 4 PM - 02/26/2021-Present Nausea - 5 PM - 02/26/2021-Present Headache - 5 PM - 02/26/2021-Present Inject Site Soreness - 5 PM - 02/26/2021 Increase in Abdominal pain - 5 PM - 02/26/2021-present 101.2 Fever - 5 PM - 02/26/2021-02/27/2021. Lowered to 100.1 2/28/2021-present. Muscle aches - 6 PM - 02/26/2021 - lasted through the night only Dizziness - 10 PM - 02/26/2021-present Dry throat and mouth/unquenchable thirst - 10 PM - 02/26/2021-present Loss of voice (no sore throat) - 11 PM - 02/26/2021 Heart racing - 02/27/2021 since waking up - lasted about 30 hours Rash on left shoulder and arms. Itchy. 2/28/2021 - 9 AM to present
27 2021-02-28 injection site reaction Left armpit lymph began to swell to beyond normal measures stretching my Brachial artery and plexus ... Read more
Left armpit lymph began to swell to beyond normal measures stretching my Brachial artery and plexus causing loss Of blood flow to my hand and feeling
27 2021-02-28 rash Rash on chest, neck, back the day after vaccine given
27 2021-02-28 vaccination site pain Sore arm where injected within an hour or so, became more sore over the next day followed by chills,... Read more
Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient (not pregnant) received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3247), intramuscular on left arm on 27Jan2021, 10:00 AM at single dose for COVID-19 immunization. Relevant medical history included minor allergies to avocados, almonds, and kiwis. Concomitant medications in two weeks included birth control and Vitamin D NOS (vitamin D supplement). No other vaccine was received by the patient within four weeks. On 27Jan2021 at 11:30 AM, the patient experienced sore arm where injected within an hour or so, became more sore over the next day (28Jan2021) followed by chills, body aches, headache and slight fever starting the morning after vaccination on 28Jan2021. No treatment was received by the patient. The patient was not tested COVID prior and post vaccination. On 03Feb2021, the patient stated that on 27Jan2021, the patient received the vaccination and first had the soreness. The patient reported on 29Jan2021 when patient had recovered from symptoms. The outcome of the events was recovered on 29Jan2021. No follow-up attempts are possible. No further information is expected.
27 2021-02-28 hives URTICARIA, THROAT TIGHTNESS, EYELID SWELLING
27 2021-03-01 redness Pt states "I received my second covid vaccine at 3:30pm on 02/25/2021 and I started feeling really t... Read more
Pt states "I received my second covid vaccine at 3:30pm on 02/25/2021 and I started feeling really tired about 20 minutes later at approx. 3:50pm. I started getting really hot and sweaty. I had my temperature taken and it was fine 97.6. My chest turned really red, and I got really sleepy. By the time I got home at 5:00pm my temperature was at 99.0. I had a headache, muscle aches all over, and chills. That evening my temp was 99.6. I took 500mg Tylenol around the clock. It hurt to move and to get up to go to the bathroom. The body aches have went away but I am still feeling really fatigued today 03/02/2021. I don't feel 100%."
27 2021-03-01 injection site pain UNKNOWN COVID VACCINE BRAND; chief complaint of generalized body aches and increased heart rate onse... Read more
UNKNOWN COVID VACCINE BRAND; chief complaint of generalized body aches and increased heart rate onset today. Per the patient, symptoms are beginning in the context of having received the second dose of her COVID-19 vaccine. Patient reports similar symptoms after her initial dose; however, these resolved shortly after. Patient states that she went to an urgent care for her symptoms but was sent to the ED for further evaluation. Back pain is describes as achy and constant.This initially began at the injection site but began to involve the back. Patient reports taking Tylenol around 1000 today without improvement in symptoms. Administered acetaminophen, magnesium (hypomagnesemia), 1 L NS bolus
27 2021-03-02 hives, itchy skin My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke ou... Read more
My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke out in hives/were itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Jan2021 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On Friday, 30Jan2021 at 11:00, the patient's face broke out in hives. They were itchy and hot, and it was sudden, over the course of 15 to 30 minutes after the itching, they appeared. The patient took cetirizine hydrochloride before bed and applied cooling balm. The hives were gone this morning. The events were considered non-serious. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
27 2021-03-04 injection site pain Headache, Injection Site Pain
27 2021-03-04 injection site swelling Light-headness within forty five minutes - a little dizzy; tiredness; nauseous; swelling on injectio... Read more
Light-headness within forty five minutes - a little dizzy; tiredness; nauseous; swelling on injection site - it was a little worse then on the first dose (I forgot to mention that I had swelling on the injection site after the first dose, too). These symptoms lasted for about two weeks. I took Benadryl to help with the symptoms - it helped the symptoms to let me to sleep. A week and a half before I took the second COVID vaccine, I had a TB test done. Exhaustion is still there and I still have nausea. Dizziness has been gone since second week of the 2nd dose of vaccine. Swelling on the injection site is gone. I had a doctor visit - Video visit with clinic and the dr recommended bedrest - February 11th or 12th - no meds given. I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy.
27 2021-03-06 injection site pain Occasional soreness at injection site. Continued experience of tiredness, sleeping at 7 or 8 PM, whe... Read more
Occasional soreness at injection site. Continued experience of tiredness, sleeping at 7 or 8 PM, when normally sleeping at 12 or 1 AM.
27 2021-03-06 injection site pain Soreness at injection site throughout day. Experiencing unusual tiredness, sleeping at 7 or 8 PM, b... Read more
Soreness at injection site throughout day. Experiencing unusual tiredness, sleeping at 7 or 8 PM, but normal sleep time is 12 or 1 AM.
27 2021-03-07 itchy rash First day: chills, headaches, muscle aches, joint aches, second day: itchy rash on hands, feet, and ... Read more
First day: chills, headaches, muscle aches, joint aches, second day: itchy rash on hands, feet, and breasts, itchy eyes and nose, sneezing
27 2021-03-08 injection site pain Pain in left arm near injection sight; pain when pressed or when arm raised and using the muscles in... Read more
Pain in left arm near injection sight; pain when pressed or when arm raised and using the muscles in that area. Slight tickle in back of throat.
27 2021-03-08 injection site pain, skin warm, injection site warmth Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+ hours as well.
27 2021-03-09 hives Approximately 90 minutes after vaccination, patient reports noticing 1 hive on left cheek, then wit... Read more
Approximately 90 minutes after vaccination, patient reports noticing 1 hive on left cheek, then within another hour developed hives on face, neck, back, and progressed to chest. Then patient reports tingling and itchiness on lips and in an around her mouth. At this point the patient took benadyl (diphenhydramine) OTC 25mg tablets. Hives resolved post-benadyl within 60 minutes and continued itchiness on skin until next morning. All symptoms/hives/itchiness resolved by next morning.
27 2021-03-09 itchy skin Nausea, fatigue, arm pain, and intense itchiness on arm
27 2021-03-10 injection site pain First, I had moderate pain in my right arm and near the injection site. After the first dose, my rig... Read more
First, I had moderate pain in my right arm and near the injection site. After the first dose, my right arm and hand became numb with loss of feeling or touch. This lasted for most of the evening, about 12 hours after vaccination. The injection site and the muscle were in a lot of pain, which climbed up into my neck muscle. I did not have any fever or chills. For the past several days, I have become fatigued very easily. Lastly, my lower abdominal area has become sore with discomfort. I have never experienced this before, and I am not currently menstruating either. Tylenol makes it better, and resting on my back and excess movement makes it worse.
27 2021-03-10 itchy skin I was nauseous after the shot but it may have been hunger and nerves. I had itchy skin for a little ... Read more
I was nauseous after the shot but it may have been hunger and nerves. I had itchy skin for a little bit on my face and arms. Then it went away. I got home around six pm. I had to go to the bathroom and first go was a mix of diarrhea and solid stools. Then as soon as I left the bathroom, I had to go back. It was fully blown diarrhea. Then I kid you not, my period came on at the same time. It is usually unpredictable but I wanted to add it just in case. And my arm became really really sore around 8pm and last night I could barely move it from the pain, or lift it. This morning it is still sore...and hurts to put pressure on .
27 2021-03-11 injection site reaction, rash, injection site rash Red eye lids, itchy, inflammation of eye lids. Soreness of arm and skin rash/slight breakout near po... Read more
Red eye lids, itchy, inflammation of eye lids. Soreness of arm and skin rash/slight breakout near point of injection on left arm only.
27 2021-03-12 dry skin Patient discharged from vaccine event asymptomatic at 1645, returned to work, then came back to vacc... Read more
Patient discharged from vaccine event asymptomatic at 1645, returned to work, then came back to vaccine tent at 1800 stating she had a "splitting headache, was cold, clammy and nauseated." Vital signs SPO2 99% HR 72 and regular, Blood pressure 148/98, skin dry, hands cool, at this time denying nausea, still with complaints of headache. At 1830 HR 75 regular heart rate remains regular, SPOS 99%, denies any airway issues, declined water or crackers, wanted to go home.
27 2021-03-12 rash with redness, rash Reaction: Red dots on bilateral arms, no itchiness or warmness Outcomes: Observed for an additional ... Read more
Reaction: Red dots on bilateral arms, no itchiness or warmness Outcomes: Observed for an additional 15 minutes, gave Benadryl 25 mg PO x1. Decreased redness after 5 min of Benadryl
27 2021-03-12 injection site pain Stiff and sore neck. Extreme pain at the injection site.
27 2021-03-13 injection site swelling, injection site redness, injection site hives, injection site pruritus Redness, swelling, itching, and hive like appearance at injection site
27 2021-03-14 itchy skin Itching all over body (but no visible rash at this time)
27 2021-03-15 hives, itchy skin I was vaccinated with the first dose of the Pfizer vaccine on 3/3/21. I started experiencing itching... Read more
I was vaccinated with the first dose of the Pfizer vaccine on 3/3/21. I started experiencing itching on my chest and back on 3/4/21. The itching sensation increased and I broke out in hives on the evening of 3/5/21. I took an antihistamine and the hives subsided. The itching and hives started near the vaccine injection site on my left arm and spread across my chest, back, and to my right arm.
27 2021-03-15 skin discolouration, skin warm, redness Warm and red skin, bloodshot eyes, dropping blood pressure, fainting, dizziness, nausea, purple feet
27 2021-03-16 injection site pain ?Dizziness almost immediately and still ongoing ?Tongue tingling about 30 minutes after shot and su... Read more
?Dizziness almost immediately and still ongoing ?Tongue tingling about 30 minutes after shot and subsiding around 1:51 ?Pain at injection site ?overall out of it ?off? feeling ?Feeling of panic ?Fatigue ?Chest feeling heavy at about 12pm on day of vaccine lasting about an hour
27 2021-03-16 itchy skin, hives, rash, dry skin Chronic hives, excessive itching, swelling of lymph nodes, skin rashes, extremely dry skin, constant... Read more
Chronic hives, excessive itching, swelling of lymph nodes, skin rashes, extremely dry skin, constant muscle spasms.
27 2021-03-16 itchy skin Pt with hx of anaphylactic reaction to several medications. After 30 minutes, pt feels tingling and ... Read more
Pt with hx of anaphylactic reaction to several medications. After 30 minutes, pt feels tingling and itchy skin on entire torso. No hives noted. No other symptoms. Actions Taken: Vitals taken at 1722 as follows: 135/82, HR 86, Respirations 14. O2 sats on RA 95%. No c/o shortness of breath, throat closing, itchy throat, SOB or stridor. After 15 minutes, Pt feels the same and no changes for the worse. Vitals at 1738 as follows 119/68, HR 85. O2 sat 96% on RA. Pt requests to head home and will take Benadryl upon arrival. Disposition: PT d/c to home per pt request @ 1820
27 2021-03-16 rash with redness Stark dark red rash on lower left breast and abdomen. Started 03/14/21 in the middle of the night w... Read more
Stark dark red rash on lower left breast and abdomen. Started 03/14/21 in the middle of the night when I was sleeping. In the morning it was still there so I took a benadryl with no relief. It became more inflamed, started itching and came with discomfort. Began feeling feverish and dizzy. Saw an NP 03/15/21 around 2:00pm and was given steroid cream to treat what she thought was an allergy. Steroid cream and cold compresses were used over the course of the next two days with no relief. Rash seemed to get bigger and darker. The rash is 4-5 irregular, textured and raised clusters about 1-2 cm in size, with mildly erythematous areas surrounding them. Saw an MD 03/17/21 around 1:30pm, believes it's a vascular response to the vaccine as the color of the rash doesn't fade when pressed on. Advises getting a biopsy if issue does not resolve or improve after 1 week. He also advised holding off on the second dose until further information is obtained
27 2021-03-17 redness Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less tha... Read more
Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.
27 2021-03-18 rash with redness, rash Client came to charge nurse complaining of red rash appearing on arms and chest 15 minutes after vac... Read more
Client came to charge nurse complaining of red rash appearing on arms and chest 15 minutes after vaccine administration. Patient was not in any visible distress. Vitals taken, blood pressure 148/111, HR 103, O2 97%, RR 20. Patient does not complain of any pain or discomfort, trouble breathing or itchiness. Benadryl 25 mg PO administered for red rash on arms and chest. Patient rested, upright in chair for additional 15 minutes. No new complaints brought up by patient. Vitals at 5:09 pm 134/90, 98 pulse, 96% O2, 98.5 temp, RR 18. Lung sounds clear. Patient able to tolerate walking and was accompanied by partner. Patient left site without incident.
27 2021-03-18 rash, itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, followed by cold sores
27 2021-03-19 hives I had minor hives on my neck and chest. I felt dizzy, foggy, and very fatigued for the rest of the d... Read more
I had minor hives on my neck and chest. I felt dizzy, foggy, and very fatigued for the rest of the day after getting this vaccine.
27 2021-03-19 injection site pruritus, injection site swelling, injection site warmth, injection site redness Redness, heat, itching and swelling 3inches by 3 inches big at injection site.
27 2021-03-20 itchy skin, injection site pruritus Exhaustion Fatigue Weakness Dizziness Itchiness of injection site, face, arms Runny nose Headac... Read more
Exhaustion Fatigue Weakness Dizziness Itchiness of injection site, face, arms Runny nose Headache
27 2021-03-20 itchy skin, redness Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/18/2021. Patient has... Read more
Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/18/2021. Patient has a medical history of Ehlers-Danlos Syndrome, Mast Cell Activation Syndrome, POTS (Postural Orthostatic Tachycardic Syndrome). Patient received approval from her doctor and specialists to receive Pfizer vaccine. The patient gave verbal consent to receive the Pfizer vaccine and was vaccinated at 1431. The patient was given an observation time of 30 minutes with EMT. At 1505, the patient reported experiencing tingling in the back of her throat. The patient presented with patchy erythema on chest and neck. The patient was brought into the exam room at 1510 and proceeded to lay down on exam table. At this time, the patient's vitals were taken by RN and found to be within normal limits (BP 115/90, HR 88 BPM, RR 15/min). The patient denied difficulty breathing. She reported feeling minor dizziness and minor itching of neck and arms. The patient's vitals were reassessed as the Lead RN drew up 50 mg/1 mL of IM Benadryl. The patient's vitals at 1518 were: BP 120/85, HR 80 BPM, RR 16/min. The patient remained A&Ox4. The patient was given 50mg of IM Benadryl at 1520 in the left anterolateral region. At 1530, Patient's vitals were: BP 117/80, HR 73 BPM, RR 12/min. At this time, the patient verbalized relief of itching in neck and arms. Upon assessment, the patient's erythema on neck and chest had resolved. At 1537, the patient sat up with her feet dangling below her, her vitals were as follows: BP 132/98, HR 73 BPM, RR 13/min. The patient reported "feeling better" and requested to use the restroom. An RN followed the patient to the restroom. Patient's gait was steady and she denied any dizziness or lightheadedness. Lead nurse educated patient on side effects of Benadryl, including drowsiness. At 1544, the patient requested to drive herself home. She was escorted to her car by lead RN. Patient drove herself home AMA at 1547.
27 2021-03-20 injection site reaction, injection site pain Prolonged pain and stiffness at vaccination site (shoulder) for 3 weeks thus far.
27 2021-03-20 vaccination site pain pain at injection site/ left arm; pain when raising arm; This is a spontaneous report from a contact... Read more
pain at injection site/ left arm; pain when raising arm; This is a spontaneous report from a contactable consumer reporting for herself. A 27-year-old non-pregnant female patient received her first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: 9266, via an unspecified route of administration, administered in left arm on 25Jan2021 at 08:45 (at the age of 27 years old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date, blood triglycerides increased from an unknown date, and drug allergy to cephalosporins from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Six hours after vaccine administration, the patient experienced pain at injection site/ left arm on 25Jan2021, and pain when raising arm on 25Jan2021. The patient did not receive treatment for the events. The outcome of the events pain at injection site/ left arm, and pain when raising arm was recovered on 26Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
27 2021-03-21 rash Patient experienced facial rash with dose 1 that was relieved with Benadryl 50mg PO. Patient experie... Read more
Patient experienced facial rash with dose 1 that was relieved with Benadryl 50mg PO. Patient experienced spreading body rash with difficulty breathing experienced as persistent cough with dose 2. Symptoms were not relieved with Benadryl 50mg PO and continued to worsen. Patient was administered 0.3mg epinephrine IM (as EpiPen), 911 was alerted, and an ambulance took patient to hospital.
27 2021-03-22 injection site pain Approx. 8 hours after the vaccine I experienced headache, diarrhea, chills and a low grade fever. Al... Read more
Approx. 8 hours after the vaccine I experienced headache, diarrhea, chills and a low grade fever. Also experienced severe pain at the injection site, that worsened over the evening. All symptoms continued through the evening. Also experienced night sweats. The following morning, headache and mild chills were present, but other symptoms had abated. Had minor brain fog. Those symptoms resolved over the course of the day. All symptoms, except night sweats, have cleared up. Night sweats are ongoing.
27 2021-03-22 rash, injection site redness Rash in both arms and redness at injection site shortly after vaccination.
27 2021-03-22 skin irritation, hives, rash, itchy skin Red/irritated skin, rash, hives, and itchy skin along both legs (front and back) - I took one Benadr... Read more
Red/irritated skin, rash, hives, and itchy skin along both legs (front and back) - I took one Benadryl pill and put anti-itch cream on both of my legs. The rash/hives were gone by morning.
27 2021-03-23 injection site rash 03/23/21 -sore arm -body aches -headaches -weakness -fatigue -chills 7:00pm -102.5 fever -ras... Read more
03/23/21 -sore arm -body aches -headaches -weakness -fatigue -chills 7:00pm -102.5 fever -rash surrounding injection site -slight swollen armpit -cold sweats -headaches -body aches 03/24/21 -101 fever -body aches -chills -cold sweats
27 2021-03-23 injection site swelling, injection site redness Fever of 104.1 lasting for 24 hours, Brady aches, chills, swelling the size of a baseball and rednes... Read more
Fever of 104.1 lasting for 24 hours, Brady aches, chills, swelling the size of a baseball and redness at injection site
27 2021-03-24 hives Urticaria. Isolated, no systemic sx such as SOB, abd pain, N/V, etc
27 2021-03-25 rash PATIENT DEVELOPED RASH IN BOTH ARMS W/IN 10 MINUTES WHICH SPREAD FURTHER TO HER FACE AND BACK, FEW M... Read more
PATIENT DEVELOPED RASH IN BOTH ARMS W/IN 10 MINUTES WHICH SPREAD FURTHER TO HER FACE AND BACK, FEW MINUTES LATER SHE DEVELOPED SHORTNESS OF BREATH AND SENSATION OF HER THROAT CLOSING. SHE WAS GIVEN BENADRYL 50 MG IM AND EPI 0.3 MG IM. THEN PARAMEDICS TRANSFERRED HER TO THE EMERGENCY ROOM.
27 2021-03-25 hives, itchy skin Patient complained of itching and hives 5 minutes post vaccination. Benadryl 50 mg IM @RD given at 1... Read more
Patient complained of itching and hives 5 minutes post vaccination. Benadryl 50 mg IM @RD given at 1:32pm. Patient felt dizzy. Laid down with feet up. Patient complained of difficulty swallowing and breathing at 1:47pm. Epipen administered on left outer thigh intramuscularly. 911 called. Transferred to Hospital via ambulance at 2:01pm. Vital signs: 1:25pm BP 110/75 O2 sat 98%, 1:30pm BP 110/80 HR 86bpm; 1:54pm BP 120/95 , HR 137 bpm, O2 sat 98%; 1:57pm HR 124 bpm. Lungs clear to auscultation. Called patient at 6:12pm for follow-up. Patient is still in the hospital for observation. She received treatment and under observation.
27 2021-03-26 injection site pain Soreness at injection site started 3 hours later. Fever over 100F, aching muscles, nausea, fatigue, ... Read more
Soreness at injection site started 3 hours later. Fever over 100F, aching muscles, nausea, fatigue, headache all started at 7am the next day.
27 2021-03-28 shingles Shingles on my right back and leg. Diagnosed by doctor that it was shingles.
27 2021-03-30 vaccination site pain fatigue; headache; chills; muscle aches; lymph node swelling; injection site pain; This is a spontan... Read more
fatigue; headache; chills; muscle aches; lymph node swelling; injection site pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) via unknown route of administration on 25Jan2021 02:00 PM at single dose in right arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history included Anxiety/depression, high cholesterol. Patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was reported as none. Concomitant medications the patient received within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL), loratadine, melatonin, norethisterone (ERRIN birth control). It was reported as in addition to the side effects of fatigue, headache, chills, and muscle aches, I experienced lymph node swelling lasting over a week as well as injection site pain which is still occurring and all on 26Jan2021. No treatment received for the adverse events. Since the vaccination, the patient had been tested for COVID-19. Patient underwent labs and procedure included PCR (Polymerase chain reaction): Negative (Nasal Swab) on 26Jan2021. The outcome of event injection site pain was not recovered, while for all other events was unknown. No follow-up attempts are possible. No further information is expected.
27 2021-04-03 injection site pruritus headache; itches at the injection site; felt a little nauseous; This is a spontaneous report from a ... Read more
headache; itches at the injection site; felt a little nauseous; This is a spontaneous report from a contactable Other HCP. A 27-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EJ1686), ), intramuscularly on Left arm on 20Jan2021 13:30 at single dose for covid-19 immunization. Other medical history includes Eczema, hypoglycemic, anemic. Known allergies includes Rondec. I had a baby. I had been weening from breastfeeding in January. As a result I start my menstrual cycle around the same day as I got my first shot. I sort of had a headache before the shot and definitely had one later that day and the next after the shot. I also felt a little nauseous the next day after receiving the shot. I also started my menstrual cycle again 2 weeks later (around February 8) which would be 2 weeks early. I've been on a birth control pill for 6 months and before having a child, would never had irregular periods. My left arm itches at the injection site for maybe 3 or 4 days. Adverse events was start date on 21Jan2021. And did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was "Recovered". Information on the batch number has been requested.
27 2021-04-22 itchy rash I developed very itchy bumps all over my body a few days after both the first and the second shot. T... Read more
I developed very itchy bumps all over my body a few days after both the first and the second shot. The bumps were much worse after the second shot and continued to linger for over a month (bumps would fade and new ones would develop. Finally I took benedryl three nights in a row and that seemed to knock them back. I've done everything I can to rule out some sort of bug. The person with whom I share a bed has not been developing these bumps. They do not resemble bed bug bites. The closest resemblance is to mosquito bites, but there are no mosquitos in this area this time of year.
27 2021-04-26 vaccination site pain soreness of the injection arm; This is a spontaneous report from a non-contactable reporter. A 27-ye... Read more
soreness of the injection arm; This is a spontaneous report from a non-contactable reporter. A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 in the left arm on 14Feb2021 (Batch/Lot number EN6201) as a SINGE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. The patient did not do a test Covid post vaccination. The patient did not receive any treatment. Patient did not receive any other vaccine in four weeks. On 14Feb2021 after the first dose of the vaccine, the patient experienced soreness of the injection arm. Outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.
27 2021-05-04 hives 3 Hives on neck and 6 hives on right arm.; This is a spontaneous report from a contactable consumer.... Read more
3 Hives on neck and 6 hives on right arm.; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 12Feb2021 (at the age of 27-year-old), as a single dose in left arm for COVID-19 immunisation at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. On 13Feb2021 at 12:00, the patient experienced 3 hives on neck and 6 hives on right arm. There was no treatment received for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was recovering. Follow-up (23Feb2021): This follow-up is being submitted to notify that the adverse event occurred date and PRD was 13Feb2021. Information on the lot/batch number has been requested.
27 2021-05-04 hives Hives; This is a spontaneous report from a contactable Other Health Professional (patient). A 27-Yea... Read more
Hives; This is a spontaneous report from a contactable Other Health Professional (patient). A 27-Year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EL3247) via unspecified route of administration at arm left on 27Jan2021 at 09:00 AM as single dose for COVID-19 immunization. Medical history included allergies to sulfa antibiotics. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was not reported. Previously patient received first dose of BNT162B2 for COVID-19 immunization. On an unknown date, patient experienced hives. No COVID prior vaccination. Patient has not tested COVID-19 post vaccination. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.
27 2021-05-05 rash AFTER 5 MINUTES OF RECEIVING 2ND DOSE OF PFIZER COVID 19 VACCINE. THE PATIENT COMPLAINED OF PALPITAT... Read more
AFTER 5 MINUTES OF RECEIVING 2ND DOSE OF PFIZER COVID 19 VACCINE. THE PATIENT COMPLAINED OF PALPITATIONS AND WAS JITTERY. SHE DEVELOPED RASH ON CHEST. 911 WAS CALLED AND EMS CAME AND TOOK PATIENT AWAY FOR OBSERVATION
27 2021-05-05 injection site reaction Severe arm pain. Throbbing. Muscle spasms at injection site. Numbness and tingling in fingers on aff... Read more
Severe arm pain. Throbbing. Muscle spasms at injection site. Numbness and tingling in fingers on affected side. No treatment appears to improve conditions.
27 2021-05-12 injection site swelling, injection site pain, injection site redness she gave it down towards her knee on her leg; injection was very painful/some burning during the inj... Read more
she gave it down towards her knee on her leg; injection was very painful/some burning during the injection; injected the area swelled up as she gave it and became red; injected the area swelled up as she gave it and became red; had a flare for the past couple of days/pretty bad flare/ put her into a flare/ Feeling really bad; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen , license party for etanercept (ENBREL). This non-serious solicited report was reported to Amgen on 05Apr2021 by a consumer from a commercial program and involves a 27 year old female patient who gave it down towards her knee on her leg (PT: product administered at inappropriate site), injection was very painful (PT: injection site pain), injected the area swelled up as she gave it and became red (PT: injection site swelling and PT: injection site erythema) while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on 04Apr2021. On 04Apr2021 last night, the patient took her first injection of Enbrel last night and when she injected the area swelled up as she gave it and became red. The patient reported injection was very painful and she recounted that she gave it down towards her knee on her leg. On 05Apr2021 same day of this report, the patient reported it was sore but no longer red. The patient was referred to HCP and arranged for an in home patient training for next injection. No treatment information was received. The outcome of the event injection site pain was reported as not recovered/not resolved. The outcome of the event injection site erythema was reported as recovered/resolved. The outcome of the events product administered at inappropriate site, injection site swelling were reported as unknown. The event injection site erythema was resolved on 05Apr2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain, injection site swelling and injection site erythema. The causal relationship between the events injection site pain, injection site swelling, injection site erythema, product administered at inappropriate site and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Causality Assessment for the events Pain during injection, Injection site redness, Injection site swelling, per Company (Amgen): related. Causality Assessment for the event Product administered at inappropriate site, per Company (Amgen): Not related. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (12Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 12/APR/2021 AND 20/APR/2021: This case was upgraded to serious case. In this follow up, it was reported that the patient had a flare for the past couple of days/pretty bad flare [PT: rheumatoid arthritis], some burning during the injection [PT: injection site pain] while receiving Enbrel, Single Dose Prefilled Autoinjector. It was previously reported that the patient first injected close to her knee and had a bad injection experience with immediate pain and swelling at the site. On unknown date in APR/2021, the patient stated that for the past couple of days she had a flare especially in her hands. On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain. On 16/APR/2021 (Friday of last week), the patient had a pretty bad flare that subsided on the weekend prior to her last injection. On 19/APR/2021, the patient injected in her thigh and she had some burning during the injection that lasted for about a minute afterwards. The outcome of the events rheumatoid arthritis and injection site pain were reported as recovered/resolved. The event injection site pain was resolved on 19/APR/2021. The event rheumatoid arthritis was resolved on an unknown date in APR/2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis, Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen Comment: This individual report does not change the safety profile of the product. Amgen Causality Assessment: Rheumatoid arthritis flare up, Product administered at inappropriate site assesses as unrelated while Injection site redness, Injection site swelling, Pain during injection assessed as related to etanercept. Follow-up (26Apr2021): The following clarification was received from Amgen to clarify the route of administration of Enbrel, included: The event reported was Product administered at inappropriate site "gave it down towards her knee on her leg [PT: product administered at inappropriate site" & "when she injected the area swelled up as she gave it and became red." Following the initial dose that was administered inappropriately, "On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain" The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Follow-up (27Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 27/APR/2021: The outcome of the previously reported event rheumatoid arthritis was updated to recovering/resolving. Action taken with Enbrel, Single Dose Prefilled Autoinjector for the previously reported event rheumatoid arthritis was updated to not applicable. In this follow up it was reported that the patient experienced a flare/ feeling really bad [PT: rheumatoid arthritis] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medication included COVID-19 (corona virus disease-2019) vaccine. On 25/APR/2021, Sunday, the patient received her second dose of COVID (corona virus disease) vaccine. So, the patient skipped a dose of Enbrel therapy. Then on 26/APR/2021, yesterday of this report, the patient felt really bad. She thought the vaccine put her into a flare. She was doing a little better today. She would restart Enbrel later today and switched her injection day to Tuesday. She also mentioned that this time, she didn't have a flare at the end of the week, as she had with her prior dose. So, she thought that without the COVID vaccine, she would had been fine. The outcome of the event rheumatoid arthritis was reported as recovering/resolving. No follow-up attempts are possible. No further information is expected. Amgen comment: This individual report does not change the safety profile of the product. The reporter's assessment of the causal relationship of the events with the suspect products etanercept and BNT162B2 (reported as "COVID vaccine") was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen's Causality Assessment: The events Pain during injection, Injection site redness, Injection site swelling were related to etanercept. The events Rheumatoid arthritis flare up, Product administered at inappropriate site were unrelated to etanercept.; Sender's Comments: The reported events of injection site pain, injection site swelling and injection site erythema were assessed as possibly related to etanercept based on temporal association and known drug safety profile. Reported event rheumatoid arthritis flare is an intercurrent medical conditions and is unlikely related to Enbrel. Pfizer comment: Confirmed the Amgen assessment for Enbrel. The reported events were assessed as not related to BNT162B2. The events preceded, most of them already recovered, at the time of vaccine injection.
28 2020-12-31 injection site pain From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had ... Read more
From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).
28 2020-12-31 itchy skin tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. ... Read more
tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.
28 2021-01-01 hives, injection site hardening, injection site swelling, injection site warmth, injection site pain 31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injectio... Read more
31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injection site 31 Dec 1700 fever 102.1, injection site welt hard, painful, hot with 3 inch diameter, severe body aches and chills. Alternating Tylenol and Motrin begins fever lowers to 99 01Jan severe body aches and chills 01Jan 1130 fever of 101.1 while continuing alternating Tylenol and Motrin administration from previous day. 02Jan no fever, mild body aches, minor swelling and tenderness of injection site.
28 2021-01-01 rash Diffuse rash on legs, buttocks, arms
28 2021-01-01 hives Hives on L wrist
28 2021-01-02 itchy skin S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557   O: Patient a... Read more
S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557   O: Patient alert and oriented, airway patent. BP 129/88 HR 74 O2 98% 1617 Repeat O2 sat 98% HR 59. Patient c/o persistent tongue swelling.   A/P: 28 F with history of nut allergy with tongue swelling after Pfizer vaccine. EMS notified 1620. Patient evaluated by EMS and declined further treatment by EMS and stated that she would walk over to ED for further evaluation.
28 2021-01-03 hardening 36 hours after vaccine my face started swelling rapidly. I had extreme swelling and hardening in the... Read more
36 hours after vaccine my face started swelling rapidly. I had extreme swelling and hardening in the areas where I have HA fillers - lips and tear troughs. Both Restylane products. Ended up going to the ER at 2 AM and receiving angioedema/anaphylaxis protocol. IV benedryl, famotidine, and solumedrol. Was put on prednisone and hydroxyzine for at home care for the next 3 days after event. Swelling went down by the next afternoon.
28 2021-01-03 hives Employee had hives the day following vaccine, went to urgent care received prednisone 50 mg with dai... Read more
Employee had hives the day following vaccine, went to urgent care received prednisone 50 mg with daily taper, hives have continued to spread daily since. No angioedema or airway issues.
28 2021-01-03 rash, hives Patient reported to me that she developed a rash to her extremities the evening of vaccination. She ... Read more
Patient reported to me that she developed a rash to her extremities the evening of vaccination. She proceeded to take benadryl. Patient reported taking benadryl repeatedly Tuesday, Wednesday, Thursday, Friday and by Saturday morning she had to go to the ER to get some steroids. Patient stated that it was a hive reaction.
28 2021-01-03 injection site pain Really strong left arm pain around injection site. Not able to extend or retract my arm for the day... Read more
Really strong left arm pain around injection site. Not able to extend or retract my arm for the day after injection. Was really painful, couldn't sleep or apply pressure to arm, also at one point I had an extremely sharp/shooting pain that was in my left arm/neck. Currently 5 months pregnant, due June 7th 2021
28 2021-01-03 rash She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate e... Read more
She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.
28 2021-01-04 itchy skin About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. ... Read more
About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. This lasted throughout the day and required 50mg of Benadryl before symptoms finally subsided around 9pm that night.
28 2021-01-04 itchy skin About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my fa... Read more
About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my face. I got in my car and realized it's not going away. I need advice on what to take for it to go away. I noticed a itchy throat. Not sure if it's something that's due to the vaccine.
28 2021-01-04 vaccination site redness, vaccination site pain Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache... Read more
Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 28-year-old female patient received bnt162b2 (lot number: EL0140), intramuscularly at arm right, first dose on 27Dec2020 10:15, at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS) and hypertension from an unknown date. The patient was not pregnant. No known drug allergies. Concomitant medication included losartan, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, redness and pain in injection site, headache on 27Dec2020 12:00. Therapeutic measures were taken as a result of body aches, chills, redness and pain in injection site, headache, treatment included Tylenol. The events were reported as non-serious. The outcome of the events was not recovered.
28 2021-01-04 blister Exactly a week later, I noticed I had a 2 inch lump underneath my chin where my lymph node, it was t... Read more
Exactly a week later, I noticed I had a 2 inch lump underneath my chin where my lymph node, it was tender to the touch. on 1/5th, I can still feel the lump, but is not longer tender to the touch. I also developed blisters ( almost like herpes like) on the R side of my nose and on the inside of my nose. I never had blisters in my life, or herpes like blisters on my face. Now on 1/5/21, the blisters are starting to dry, but are still there. I as ask to contact you guys to see if I can get my second dose.
28 2021-01-04 rash with redness Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minu... Read more
Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minutes, her symptoms returned and another Epinephrine given IM
28 2021-01-04 vaccination site pain, vaccination site swelling, vaccination site redness Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tende... Read more
Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; Tenderness, redness, and swollen at injection site. Approximately 2 inches by 1 inch in size.; This is a spontaneous report from a contactable other HCP (patient herself). This 28-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route of administration, on 19Dec2020 at 15:00 at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant. Relevant medical history included sinus tachycardia and obstructive sleep apnea. Patient's Body mass index (BMI) is more than 35. No known allergies. Relevant concomitant medications included ibuprofen. The patient was vaccinated at Clinic, age at vaccination was 28-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 28Dec2020, at 12:30, the patient developed tenderness, redness, and swollen at injection site, approximately 2 inches by 1 inch in size. The patient was not treated for the events. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
28 2021-01-04 rash fever, aches, headache began 2 hours after vaccination but persisted over 48 hours. Tested for COVI... Read more
fever, aches, headache began 2 hours after vaccination but persisted over 48 hours. Tested for COVID per employee health policy on 12/31 - negative. Rash began 2 days after vaccination. was seen at Urgent care on 1/2/21, given prednisone. Rash worsened, fever broke. seen again 1/3/21 - given kenalog shot. tested for COVID-19 (negative). Rash continues to spread, headache improved but not resolved.
28 2021-01-05 vaccination site itchiness Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a conta... Read more
Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, via an unspecified route of administration in the right arm on 30Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included an allergy to tegaderm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen, zinc, methocarbamol (ROBAXIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took chlorhexidine and experience allergies. On 30Dec2020 at 21:30, the patient experienced arm sore/upper arm sore, itching surrounding vaccine site. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the arm sore/upper arm sore, itching surrounding vaccine site was unknown.
28 2021-01-05 skin infection at injection site, injection site inflammation, injection site redness, injection site swelling, cellulitis, skin reaction swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to t... Read more
swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area; redness; to the arm/deltoid area; inflammation; to the arm/deltoid area; swelling/cellulitis in her left arm/swelling; to the arm/deltoid area; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) intramuscular at left deltoid on 16Dec2020 16:45 at single dose for Covid-19 immunization at a hospital facility and not in a military facility. Medical history included ongoing acne. Concomitant medications included ongoing spironolactone for acne. The patient did not receive any other vaccines the day or 4 weeks prior Covid-19 vaccine. The patient informed that after 8 days of getting Covid vaccine she has swelling/cellulitis in her left arm. The patient got the COVID-19 vaccine and had kind of a delayed reaction. She got the vaccine on 16Dec2020 16:45 pm at her workplace. The patient informed that she had no reaction right after the vaccine. On 24Dec2020, the patient experienced redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area. The patient got antibiotics and it has improved. The reporter informed that the events required visit to physician office. The outcome of the events swelling/cellulitis in her left arm/redness, inflammation, swelling that looked like cellulitis to the arm/deltoid area was recovering. The patient was queried regarding seriousness of the events and the patient stated "it could have potentially dangerous." The patient wanted to know if she should get second dose of the vaccine.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site cellulitis, vaccination site erythema, vaccination site inflammation and vaccination site swelling cannot be excluded.
28 2021-01-05 vaccination site pain swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild... Read more
swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild tummy ache; body aches; This is a spontaneous report from a contactable other health professional (other-HCP) (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot number: EI0142) intramuscularly at left arm on 30Dec2020 at 06:30 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies: trees, grass, pollen, certain flowers, indoor allergens (don't know specifics). No other medical history. The patient was not pregnant. Other medications the patient received within 2 weeks of vaccination included loratadine/pseudoephedrine sulfate (CLARITIN D-12), drospirenone/ethinylestradiol betadex clathrate (YAZ) and mometasone furoate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events pain in the injection site, swollen lymph nodes on neck, mild tummy ache, body aches, low grade fever, general body fatigue; all occuring the day after injection, on 31Dec2020 at 06:15 AM. The events were reported as non-serious. Treatment received for events included tylenol took on 31Dec2020 at 8:40 PM. The outcome of event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
28 2021-01-06 injection site pain Patient received the covid vaccine on 1/26/2021 Two hrs post injection c/o pain/soreness at site. F... Read more
Patient received the covid vaccine on 1/26/2021 Two hrs post injection c/o pain/soreness at site. Four hrs post injection c/o general body ache, slight headache, fever 99.7. Denies any respiratory, ocular, or GI symptoms. Note - injection lot # not available.
28 2021-01-06 hives Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and naus... Read more
Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and nausea since last night.
28 2021-01-06 redness Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be ... Read more
Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be red faced along with redness in her throat and chest. Pt given Benadryl 25 mg liquid po at 0925 am and coaching for slowed breathing and symptoms recovery. She reported feeling better gradually and with in 15 minutes pt felt much better she declined ER transport
28 2021-01-06 injection site pain had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included c... Read more
had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.
28 2021-01-07 rash macular 2 hours after receiving the vaccine, patient noticed blochiness on chest and fever. Last 2 hours a... Read more
2 hours after receiving the vaccine, patient noticed blochiness on chest and fever. Last 2 hours and the went away.
28 2021-01-07 vaccination site pain Chills; subjective fevers less than 100; fatigue; soreness at injection site; This is a spontaneous ... Read more
Chills; subjective fevers less than 100; fatigue; soreness at injection site; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Dec2020, the patient experienced chills, subjective fevers less than 100, fatigue, and soreness at injection site 24 hours. The clinical outcome of chills, subjective fevers less than 100, fatigue, was recovered on an unspecified date. The clinical outcome of soreness at injection site 24 hours was recovered on 17Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
28 2021-01-07 rash, vaccination site rash Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection s... Read more
Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.
28 2021-01-07 injection site pain First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd CO... Read more
First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd COVID-19 Pfizer vaccine. 27 hours following administration of the vaccine in addition to body aches and chills, I then experienced headaches, fever of 101.8, and fatigue.
28 2021-01-07 vaccination site pain Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fati... Read more
Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; This is a spontaneous report from a contactable other hcp reporting for herself. This 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose on 15Dec2020 14:00 (Lot # EK5730) in the left arm and the second dose on 04Jan2021 12:45 (Lot # EL1284) in the right arm, both via an unspecified route of administration at single dose for Covid-19 immunisation. Medical history included asthma and allergies to Penicillin and Oxycodone. Concomitant medication included omalizumab (XOLAIR), salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 04Jan2021 23:00, the patient experienced injection site soreness, fatigue/chills (day). Bad diarrhea at night. No treatment was performed. The outcome of the events was recovered. The patient underwent lab tests and procedures which included Nasal Swab, Covid test on 28Dec2020 was negative. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.
28 2021-01-07 injection site pruritus, itchy skin, hives Patient began experiencing itching at the injection site and then all over her body. She started fee... Read more
Patient began experiencing itching at the injection site and then all over her body. She started feeling very warm and developing hives. She was given diphenhydramine 25mg by mouth. 911 was called and she was taken to the ER. The ambulance arrived about 5 minutes after 911 was called.
28 2021-01-07 rash, itchy skin, redness Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tong... Read more
Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tongue and inside of the mouth was itchy, rash on upper body and swollen inflamed painful lips.
28 2021-01-08 injection site hardening, injection site pain Myalgia Narrative: Localized injection site tenderness and induration- mild
28 2021-01-08 injection site pain Sore arm after IM injection surrounding injection site lasting 24 hours
28 2021-01-08 injection site pain Soreness in the site of injection on the day of vaccination. Muscle aches, headache and fever began ... Read more
Soreness in the site of injection on the day of vaccination. Muscle aches, headache and fever began 12 hours after injection. Fever spiked up to 104.1F 16 hours after vaccination. Took Tylenol at hour 16 to help bring fever down. Temperature now 100F and it has been 18 hours since vaccination.
28 2021-01-09 injection site pain Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches,... Read more
Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches, severe nausea and temperature 99.8 F. I treated the nausea with Zofran with some improvement in nausea, but other symptoms continued. My max temperature (without antipyretic affecting) was 100.7 F with continued nausea, body aches, fatigue and headache until the 24 hour after vaccine time frame. After 24 hours, nausea had improved largely to just mild, mild headache continued and fatigue/body aches. Around 28 hours, temp was 100.2 F (outside of last antipyretic dose) with same symptoms. Now around 30 hours out with recent Motrin taken, my nausea is still mild, low appetite, improved body aches and less fatigue. I have not had any site reactions other than pain starting around 6 hours after injection. Course to come yet unknown.
28 2021-01-09 injection site pain Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours aft... Read more
Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours after shot
28 2021-01-09 itchy skin, injection site swelling Systemic itching, systemic tingling, Hypotension, syncope, Bradycardia, injection site swelling
28 2021-01-10 injection site pain At about 11pm the night of vaccine (1/6/2021) my arm began to feel sore at injection site. Then 5 am... Read more
At about 11pm the night of vaccine (1/6/2021) my arm began to feel sore at injection site. Then 5 am (1/7/2021) my head began to hurt. I then had a fever of 100.7 beginning at 6:45 am (1/7/2021). Throughout the day I had chills and my temp fluctuated between 99.6 and 100.4.
28 2021-01-10 injection site pain Both at time of first vaccine (12/19) and second vaccine (1/5) I had the same symptoms: headache, mu... Read more
Both at time of first vaccine (12/19) and second vaccine (1/5) I had the same symptoms: headache, muscle and joint aches, malaise, fatigue, and pain at injection site
28 2021-01-10 injection site warmth, injection site hardening, injection site redness Fever (tmax 100.9), headache, and fatigue with body aches and chills that began the day after receiv... Read more
Fever (tmax 100.9), headache, and fatigue with body aches and chills that began the day after receiving the vaccine. 7x8cm area of erythema, warmth and induration at injection site.
28 2021-01-10 injection site pain Pain at injection site. Fever, body aches, joint aches, headache, fatigue, cough, chest pain.
28 2021-01-10 hives Urticaria-starting at 0645 1/11/2021
28 2021-01-10 injection site rash, hives Welt developed at the injection site to about 4 inches in diameter
28 2021-01-11 hives Anaphylaxis Chest tightness started @ 6:00pm following vaccine. Developed wheezing in all lung fiel... Read more
Anaphylaxis Chest tightness started @ 6:00pm following vaccine. Developed wheezing in all lung fields (confirmed by MD.) Developed hives- Albuterol, Benadryl and epinephrine administered @ 700pm. EMS called and transported to Hospital.
28 2021-01-11 injection site rash, rash, injection site redness Developed a red rash to injection site that soon spread across upper back and neck. No shortness of... Read more
Developed a red rash to injection site that soon spread across upper back and neck. No shortness of breath. No difficulty breathing. No loss of consciousness. 10:25 pm - Epi pen 0.3 mg IM given x 1 . Benadryl 50 mg x 1 dose given. EMS called and arrived within 4 minutes. Patient transported to local ER for further evaluation and treatment.
28 2021-01-11 vaccination site itchiness, vaccination site rash Mild rash and itching around injection site; itching around injection site (multiple small red bumps... Read more
Mild rash and itching around injection site; itching around injection site (multiple small red bumps); itching around injection site (multiple small red bumps); This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 14:45 on 29Dec2020 at single dose for COVID-19 immunization. Medical history included celiac disease, Sjogren's syndrome, connective tissue autoimmune disease, allergies to Gluten. Concomitant medication included cetirizine, citalopram, curcuma longa (TURMERIC), ergocalciferol (VIT D), ethinylestradiol, norethisterone acetate (MICROGESTIN), fish oil, hydroxychloroquine, pantoprazole, simethicone, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild rash and itching around injection site (multiple small red bumps) on 31Dec2020, all events were reported as non-serious. The patient did not receive any treatment from events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. Information on the lot/batch number has been requested.
28 2021-01-11 injection site redness, injection site pruritus, injection site swelling Swelling red itchy injection site, fever, back pain, nausea/vomiting, headache
28 2021-01-12 redness, injection site rash, injection site pruritus, injection site swelling Headache, fatigued, red and swelling of infection site, rash and itching at injection site.
28 2021-01-12 injection site pain I noticed on January 12 that my left arm where I received the shot my bones were aching and my joint... Read more
I noticed on January 12 that my left arm where I received the shot my bones were aching and my joints (my shoulder, my elbow, my forearm bones, and all my hand joints) were aching and my hand was slightly swollen. My coworker reported aching joints two days after she received the vaccine. So I?m not sure if my aching joints are related to the vaccine but I?m suspicious they are.
28 2021-01-12 injection site pain, injection site tingling, injection site swelling, injection site redness Injection site pain, tingling, swelling, redness. Flushing of face. Diarrhea. Improving.
28 2021-01-12 itchy skin, redness Itchiness all over the body - comes and goes. Redness on upper body.
28 2021-01-12 injection site redness, injection site mass, injection site pain My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles w... Read more
My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles were achy, felt weak, my neck was sore and I had a knot at the injection site. I took 400 mg of ibuprofen around 7am on 1/12 and my symptoms subsided until around 3pm and started getting chills and leg aches. My arm developed redness right where the knot is on my arm and I still have the knot today (1/13). I have had no other symptoms since 3pm 1/12.
28 2021-01-12 skin warm, pain of skin at about 20 hours post vaccination I had onset of fatigue, generalized body aches, joint aches, head... Read more
at about 20 hours post vaccination I had onset of fatigue, generalized body aches, joint aches, headache, and felt febrile. I took my temperature twice in the absence of antipyretics and did not have a fever (98.7 and 98.2) but my skin felt hot and painful as it does when I have had a fever in the past. By about 5:00 or around 24 hours post vaccination, all symptoms resolved aside from fatigue and headache, but the headache was less than it was before. I experienced those symptoms for the rest of the evening and woke up this morning feeling completely normal.
28 2021-01-12 redness, itchy skin, rash papular, vaccination site pain, vaccination site rash, vaccination site itchiness dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and brok... Read more
dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and broke out in rash around injection site; pain and stinging on injection site location; heat and redness as well as a raised rash; heat and redness as well as a raised rash; Both ears got, rot and itchy, stomach itchy; Both ears got, rot and itchy, stomach itchy; fever of 100.7; sever heart burn; severe body aches; head ache; raised rash; This is a spontaneous report from a contactable other Health Care Professional (HCP) who is the patient. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown, expiration date unknown) via an unspecified route of administration on 04Jan2021 at 10:00 AM (at the age of 28-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included removal of a metastatic carcinoid tumor from an unknown date and unknown if ongoing. The patient's allergies include minor hive breakouts from "several things." The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 17-DEC-2020 at 14:00 (at the age of 27-years-old) at an unspecified dose in the right arm. The patient was not pregnant at the time of this vaccination. The patient was administered the vaccine in the hospital. Prior to this vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included drospirenone;ethinylestradiol;levomefolic acid (reported as "generic form of Beyaz") and acetaminophen.The patient did not receive any other vaccines within four weeks prior to the first vaccination. On 04Jan2021 at 10:00 PM the patient experienced severe body aches and head ache, through out that night. She had dizziness and nausea with increased joint pain and body aches with the head ache increasing as well. On the morning of 05Jan2021 she experienced a fever of 100.7 and body aches. On that same day in the afternoon these symptoms subsided. She also experienced severe heart burn on 05Jan2021 that did not subside with Tums. On Wednesday 06Jan2021 she was feeling much better, and she had a "normal day." At 12:00 AM on 07Jan2021 the patient started itching and broke out in a rash around the vaccination site, and pain and stinging at injection site. She also had heat and redness as well as a raised rash. Both ears got, hot and itchy, her stomach was itchy but not red or swollen, same for the right leg and foot. She took one allergy pill, and twenty minutes later was still having a bad reaction so she took another allergy pill. She stayed awake to fill out this form, and she was hoping the reaction would stop spreading. Treatment was reported as having taken Tums for the severe heart burn and the patient also took an unspecified "allergy pill" for the itching, vaccination site rash, pain and stinging, the heat, redness and raised rash, the red, hot itchy ears, and the itchy stomach. The clinical outcome of the events severe body aches and fever was reported as recovered on 05Jan2020. The clinical outcome of headache, dizziness, nausea, joint pain, heartburn, vaccination site rash, vaccination site pruritus, vaccination site pain, feeling hot, redness, itchy, ear disorder and raised rash was reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
28 2021-01-13 injection site pain 1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills... Read more
1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills, and headache. 1/12/2021 8:00am - severe body aches, fever up to 101.0 degrees Fahrenheit after takingTylenol and chills. 1/12/2021 6:00pm - fever 100.6 degrees Fahrenheit after taking Tylenol, shortness of breath, and deep dry cough. 1/13/2021 11:00am -shortness of breath, deep dry cough worsening with tachycardia. Went to urgent care diagnosed with upper respiratory infection due to second covid vaccine reaction prescribed prednisone.
28 2021-01-13 injection site swelling About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly b... Read more
About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly burning sharp pain, but some restricting tight pain as well, radiating to my back mostly. It would be relieved for maybe 10 minutes at a time but then flare back up for about 5 hours. I went to the emergency room, where they did a cardiac work up including blood work and EKG, vitals and a chest X-ray, all which were unremarkable. At about 0200 am on 01/13, the pain subsided. Previous to the chest pain, during the morning and afternoon of 01/12, I had a low grade fever (99.9 F), an intense headache, and fatigue. 01/14/21 sore swollen lymph node under L arm.
28 2021-01-13 vaccination site pain Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pa... Read more
Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pain); Mild back pain on injection side; This is a spontaneous report from a contactable Nurse (the patient). A 28-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246, expiration date unknown) via an unspecified route of administration on 05Jan2021 at 08:45 (at the age of 28 years old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date, allergy to Penicillin and seasonal allergy from unknown dates.The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. Prior to the vaccination, the patient was diagnosed with COVID-19 (date not specified) The patient's historical vaccines include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK5730, expiration date unknown) on 15Dec2020 at 3:00 PM (at the age of 28 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient was tested for COVID-19 after the first vaccination in the form of a nasal swab test on 24Dec2020 which was negative. Concomitant medication included cetirizine hydrochloride (ZYRTEC), biotin (BIOTIN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports having experienced a headache five (5) hours post the second vaccine, soreness at injection site, fatigue and muscle aches eight (8) hours post the second vaccine, chills and dizziness twelve (12) hours post the second vaccine, and TMJ aching and mild back pain on injection side twenty-four to forty-eight (24-48) hours post the second vaccine. Treatment was received for the events and included acetaminophen and ibuprofen.The clinical outcome of the events headache, vaccination site soreness, fatigue, muscle aches, chills, dizziness, joint aching and back pain was reported as recovered on an unspecified date in Jan2021. It is unknown if the patient has been tested for COVID-19 since the second vaccination.
28 2021-01-13 rash, itchy skin Developed a rash around my neck and swollen eyes (thought to be poison ivy) on 1/3/2021. Since that ... Read more
Developed a rash around my neck and swollen eyes (thought to be poison ivy) on 1/3/2021. Since that time, the rash has spread to my back, abdomen, chest, neck, ears. It appears to be urticaria and is extremely itchy. I completed a steroid taper early on and the rash is no loner affecting my face. I am taking daily antihistamines and using hydrocortisone cream for the itching. The rash continues to spread and is made worse with scratching. I am unsure if this is related to the vaccine, but this has never happened before and I have no known allergies. I got the second vaccine on 1/8/2021 (at the time the rash was improving and I thought it to be poison ivy).
28 2021-01-13 itchy skin, hives Hives on left arm several inches from vaccination site and one hive present on left thigh - patient ... Read more
Hives on left arm several inches from vaccination site and one hive present on left thigh - patient unable to wait the 15 minutes, sx occurred 5 minutes post vaccination. Itching occurring on left arm and thigh and chest. No respiratory or cardiac symptoms. Self-administered Claritin after sx occurred.
28 2021-01-13 hives, itchy skin I received the second dose of the Pfizer vaccine on 1/8/2021. The following day I had mild hives on ... Read more
I received the second dose of the Pfizer vaccine on 1/8/2021. The following day I had mild hives on my neck and thigh creases, I attributed it from sweating, hives went away after taking Claritin. The evening of 1/11/2021 I had 1 glass of wine and subsequently broke out into hives all over my chest and neck, took Benadryl that night. In the morning of 1/12/2021 the hives had worsened. I started Prednisone 40mg, Claritin, Pepcid 20mg in the AM and Prednisone 20mg, Benadryl, Pepcid 20mg at night. The following day the hives had mostly resolved and I only took the OTC medications. In the afternoon of 1/13/2021 I rode my stationary bike. After the ride I had broke into hives again on my chest and neck and where my headband sat. I then took Prednisone 40mg, Benadryl 25mg, Pepcid 20mg. Hives have mostly resolved today 1/14/2021, still have the sensation of itchiness. Never had throat closing or shortness of breath.
28 2021-01-13 hives, itchy skin Patient began itching on chest and showing hives on upper arms. Patient then was learing throat, cou... Read more
Patient began itching on chest and showing hives on upper arms. Patient then was learing throat, coughing, tingling in the tongue. Itchiness progressed down arms, as did hives. EMS arrived and administered 0.3 mg Epi IM and IV Benadryl. Vitals obtained.
28 2021-01-13 hives reported generalized uriticaria
28 2021-01-13 injection site pain same day: pain at injection site next day: headache, fatigue, paint at injection site, muscle aches ... Read more
same day: pain at injection site next day: headache, fatigue, paint at injection site, muscle aches 2 days after: no symptoms
28 2021-01-14 vaccination site pain Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back... Read more
Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
28 2021-01-14 rash with redness, hives Hours after first COVID vaccine 12/18 developed facial and lip swelling then urticaria on arms and n... Read more
Hours after first COVID vaccine 12/18 developed facial and lip swelling then urticaria on arms and nonpruritic, erythematous rash chest to thighs. Woke that night with tachycardia to 220's. Tachycardia of varying degree and severe diaphoresis was constant through the next 72 hours. Did not seek care. Since then, for 3 weeks she has had multiple runs of SVT. Last one was Saturday 1/9 - went to ER, episode recorded. Given rx of xanax which did not resolve her tachycardia. Established care with me 1/14/2021 and noted to have 3/6 systolic murmur. Patient (who is a PA) states it is significantly louder than it was prior to vaccination. Given rx of prn propranolol for home, outcome pending
28 2021-01-14 injection site pain Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin... Read more
Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin tingling, joint pains, muscle aches
28 2021-01-14 injection site pain Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and ... Read more
Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and sweaty with a headache and body aches
28 2021-01-14 itchy skin, redness, hives Within 10 mins I had Hives on my chest and back. My face and ears started turning bright red and swe... Read more
Within 10 mins I had Hives on my chest and back. My face and ears started turning bright red and swelled a little. Then for a week I was itchy. I took Benadryl and hour after the incident. The EMS monitored me while It was happening and since I was still breathing ok I decided to leave and get Benadryl since they didn't have any.
28 2021-01-15 itchy skin, hives Almost 24 hours after receiving I got really itchy all over my body and had hives on my inner thighs... Read more
Almost 24 hours after receiving I got really itchy all over my body and had hives on my inner thighs.
28 2021-01-17 itchy skin Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calmi... Read more
Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calming down after 10 minutes and drinking water. Her face did appear flushed but she also said it was flushed before she got the injection. No difficulty breathing, no obvious urticaria. She was emotional about losing her mom to anaphylaxis at age 10, stated that her sister also has similar allergy profile. She questioned if she should et the second vaccine dose.
28 2021-01-17 vaccination site pain Recieved dose #1 of Pfizer Covid vaccine on 18Dec2020 with very mildly sore arm at injection site.; ... Read more
Recieved dose #1 of Pfizer Covid vaccine on 18Dec2020 with very mildly sore arm at injection site.; This is a spontaneous report from a non-contactable nurse. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK798), intramuscular in the right arm on 18Dec2020 13:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included ergocalciferol (VIT D), ethinylestradiol, norethisterone (NORTREL [ETHINYLESTRADIOL;NORETHISTERONE]). The patient previously took and had allergies with Phenergan. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 post vaccination. The patient received first dose of Pfizer Covid vaccine on 18Dec2020 with very mildly sore arm at injection site on an unspecified date with outcome of recovering. The event was reported as non-serious. No treatment received for the event. No follow up attempts are possible. No further information is expected.
28 2021-01-17 itchy skin difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchines... Read more
difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-01-17 vaccination site pain localized pain at the injection site; This is a spontaneous report from a contactable consumer (pati... Read more
localized pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at a single dose to prevent COVID-19. The patient had no medical history. There were no concomitant medications. The patient got the second dose of the Covid-19 vaccine on Friday, 08Jan2021 (lot number: EK9231, expiration date: Apr2021). She didn't have a fever or chills, but she had localized pain which she also had with the first dose. She still has pain in her armpit, to the touch and when she moves it, but there is no swelling, lumps or bumps. The pain has decreased; it's not as bad as it was when she first noticed it. The localized pain at the injection site was worse with the first injection in Dec2020; she just did not have the underarm pain and she didn't have any pain until the day after she got the first dose. She got the 2nd dose at 5:30pm, and had pain at around 8pm or 9pm that night. The following day was the height of the pain for the second dose, and it has been decreasing since then. She got both doses in her left arm. Outcome of the event was unknown.
28 2021-01-18 injection site pain 1/14/21 severe chills , fever of 101.9, treated with ibuprofen throughout entire day, sweats, head... Read more
1/14/21 severe chills , fever of 101.9, treated with ibuprofen throughout entire day, sweats, headache, fatigue, body aches, nausea, soreness at injection site 1/15/21 headache, fatigue, body aches, nausea, dizziness, soreness at injection site, numbness and soreness of right 5th metacarpal; took ibuprofen for headache 1/16/21 headache, dizziness, fatigue, nausea, body aches, numbness and soreness of right 5th metacarpal 1/17/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal; took Tylenol for headache 1/18/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal 1/19/21 tiredness, nausea, numbness of right 5th metacarpal
28 2021-01-18 injection site pain Pfizer-BioNTech COVID-19 Vaccine: Pain at injection site, Fatigue, Dizziness
28 2021-01-18 injection site pain Woke up the morning after the vaccine with dizziness, nauseous, dull headache, sensitivity to light/... Read more
Woke up the morning after the vaccine with dizziness, nauseous, dull headache, sensitivity to light/sun. Feeling some pain at injection site and is similar to the first vaccine in the series. Has not yet taken any meds to alleviate the reactions; but will take Advil. After the first injection, patient mainly had injection site pain, but no other adverse reactions. Has not contacted doctor regarding reaction, but is not going in to work.
28 2021-01-18 injection site pain, injection site pain severe pain in administered arm. called in sick to work.
28 2021-01-19 injection site pain, pain of skin Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection s... Read more
Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection site)
28 2021-01-20 skin burning sensation Patient reported skin burning and nausea/vomitting for 3 to 4 days
28 2021-01-20 itchy rash, rash with redness, redness, injection site redness, injection site pruritus, injection site rash, rash papular Red bumpy, itchy rash developed a few hours after receiving vaccine (vaccine received at 1100, itchi... Read more
Red bumpy, itchy rash developed a few hours after receiving vaccine (vaccine received at 1100, itching, redness, and rash began around 1330), localized to injection site, over course of 24 hours spread to face, entire trunk, and upper thighs. Notified physician, who order medrol-dose pack. Treatment started at 2130on Saturday, 1/16/21. Symptoms began to decrease within 3 hours, subsided within 48 hours.
28 2021-01-20 rash, shingles Shingles Virus- Rash began Friday 1/15/21 (about 48 hours after vaccination) on back left side, rash... Read more
Shingles Virus- Rash began Friday 1/15/21 (about 48 hours after vaccination) on back left side, rash spread to underneath left breast
28 2021-01-21 redness Ears erythema and itching
28 2021-01-21 injection site pain I just wanted to report an incident that occurred after receieving the first dose of the covid vacc... Read more
I just wanted to report an incident that occurred after receieving the first dose of the covid vaccine. It was not one of the possible reaction from covid vaccine but rather administrator error in injecting the vaccine. The symptoms appeared about 3 hours after receiving the vaccine, now have numbness, tingling, pain and burning sensation on my left pam in the arm of given vaccine. Obviously, the person giving the vaccine, hit the nerve.
28 2021-01-21 hives Patients described tachycardia and hives all over her body.
28 2021-01-21 rash, skin burning sensation Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after vaccine given. Patient also noticed stiffness in neck, feeling of pins and needles and some skin burning. Additionally endorses feeling a dry mouth sensation.
28 2021-01-21 rash, hives, rash with redness Two to three hours after receiving the second dose of COVID-19 Pfizer-BioNTech vaccine, the patient ... Read more
Two to three hours after receiving the second dose of COVID-19 Pfizer-BioNTech vaccine, the patient began to have generalized rash erythematosus with hives. The patient was transferred to the Emergency Room and following the evaluation the patients was treated with Solu-medrol 125 mg IV single dose and Benadryl 25 mg IV. single dose.
28 2021-01-23 injection site pain Temp 100.2, headache, fatigue, muscle or body aches and pain at injection site
28 2021-01-24 injection site warmth, injection site nodule, injection site swelling, injection site redness, injection site pruritus Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and... Read more
Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5 1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet 1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps 1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen
28 2021-01-24 redness, itchy skin, rash Rash on chest, back, and left arm. Redness and itch.
28 2021-01-24 injection site pain Severe shaking about 12 hours after injection. Started as shivering and turned into full body convul... Read more
Severe shaking about 12 hours after injection. Started as shivering and turned into full body convulsions lasting just over an hour. Bundling up in blankets did not help as shaking intensified. Only other side effect was a sore arm at injection site.
28 2021-01-24 rash, itchy skin, hives rash, welts, & itching
28 2021-01-24 vaccination site pain sore arm at the injection site; I then woke up with a headache and had a fever with chills. Max temp... Read more
sore arm at the injection site; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EK9231) , via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose on 16Dec2020 (lot no: EH9899) administered on left arm. Patient was not pregnant. The patient has no COVID prior vaccination. On 07Jan2021, patient stated "I had a sore arm at the injection site. I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2- 100.4 for majority of day and decreased to 99.6 that night. It only lasted the day after being vaccinated" The patient recovered on unspecified date from all of the events. The patient has not tested COVID on post vaccination. No follow-up attempts are possible. No further information is expected.
28 2021-01-25 hives Hives/welts / Headache / body aches / chills
28 2021-01-25 sensitive skin, itchy skin I had a fever in the middle of the night, but no pain at the injection site. On Monday, January 25 ... Read more
I had a fever in the middle of the night, but no pain at the injection site. On Monday, January 25 my arm and part of my back felt like they were burning/itching and were sensitive to clothing and clothing tags. Not anything major or that i'm too concerned about, but wanted to know if any others have experienced this as well. My skin isn't red and there's no rash- it is only hypersensitive to touch. I don't have any food allergies or any allergies to medicines. I've never had adverse reactions from a vaccination before and my skin is typically not sensitive to anything.
28 2021-01-25 vaccination site pain fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report ... Read more
fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscularly at site of left arm at 07:00 on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (lot number: EL3248), intramuscularly at site of left arm at 7:00 AM on 22Jan2020 for COVID-19 immunization and experienced injection site pain. The patient experienced fever of 102, chills, nausea, vomiting, headache and injection site pain, all at 23:00 on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. Adverse reactions did not result any serious consequences. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
28 2021-01-25 vaccination site warmth, vaccination site redness red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for inf... Read more
red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; red and warm at day 10 in same arm as vaccine was administered in. Required oral antibiotics for infection.; Enlarged axillary lymph node/Became red and warm at day 10 in same arm; This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine, lot EH9889), via an unspecified route of administration in the left arm on 28Dec2020 11:45 at SINGLE DOSE for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included allergy to latex and COVID prior vaccination: No. No other vaccine in four weeks. Concomitant medication included unspecified oral contraceptive. The patient experienced enlarged axillary lymph node that appeared 8 days after vaccine administration (05Jan2021). It became red and warm at day 10 (07Jan2021) in same arm as vaccine was administered in. Required Keflex 500 mg oral antibiotics for infection. No Covid tested post vaccination. The outcome of events was recovering.
28 2021-01-26 hives My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was ad... Read more
My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .
28 2021-01-26 injection site pain Pfizer-BioNTech Covid 19 vaccine EUA. Sore at injection site
28 2021-01-26 vaccination site pain Tenderness at site Low grade fever; Tenderness at site Low grade fever; This is a spontaneous report... Read more
Tenderness at site Low grade fever; Tenderness at site Low grade fever; This is a spontaneous report from a non-contactable Nurse(patient). A 28-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown), via an unspecified route of administration at left arm on 12Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included hypothyroidism. No COVID prior vaccination, no COVID tested post vaccination, no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), ethinylestradiol, norgestimate (SPRINTEC). No other vaccine received in four weeks.The patient experienced tenderness at site low grade fever on 13Jan2021 04:00. Facility type vaccine was hospital. No treatment received. Outcome was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
28 2021-01-27 injection site swelling Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigu... Read more
Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigue
28 2021-01-27 vaccination site pain Injection site pain with 1st dose; This is a spontaneous report from a non-contactable other healthc... Read more
Injection site pain with 1st dose; This is a spontaneous report from a non-contactable other healthcare professional. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3248, intramuscular on 22Dec2020 07:00 at a single dose on left arm for COVID-19 immunization. There were no medical history or concomitant medications. The patient is not pregnant and had no known allergies. The patient had no prior vaccination and not tested post vaccination. The patient experienced injection site pain with 1st dose. There was no treatment received. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
28 2021-01-27 itchy skin, skin tightness, injection site discomfort all over itching tightness at immunization site and across shoulders headache
28 2021-01-28 rash Rash; This is a spontaneous report from a contactable physician (patient). A 28-year-old female pati... Read more
Rash; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 07Jan2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included history of seafood allergy during the childhood and allergic reaction to shampoo, conditioner and skincares. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jan2021 (reported as around a week after the second shot), the patient experienced rash. The patient took an antihistamine as treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was unknown.
28 2021-01-28 skin warm, redness Sore arm (and got really red; tender and really swollen) and body aches and muscles aches; slight fe... Read more
Sore arm (and got really red; tender and really swollen) and body aches and muscles aches; slight fever; severe headache and chills -counted get warm - lasted about 48 hours. But my arm was really sore for another 2 days after all the other symptoms cleared. Treated with Tylenol around the clock throughout.
28 2021-01-28 rash, rash papular, rash macular This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patien... Read more
This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date not reported), via an unspecified route of administration in the left deltoid on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis from 2009 and exposure to a positive COVID patient on 08Jan2021. The patient also had a sinus drainage down the back of her throat. It went away but started back up on 09Jan2021. It is the same since last night but had improved from over the weekend. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) on 21Dec2020 at single dose for COVID-19 immunisation. The patient had her second COVID19 Vaccine dose last Saturday and reported having a "weird reaction". She had already gone to urgent care and was told to call. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist), which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Patient said that she was not sure if she was having a reaction or not to the Pfizer COVID Vaccine. She was just in urgent care that morning and was going to primary care that afternoon. Urgent care thought she was having a reaction. She got her second dose of the vaccine on Saturday morning, 09Jan2021. That night she had the typical immune response. She had chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure, which lasted through Sunday. She took Sudafed PE and Monday when she woke up, she felt normal. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist, fingers, feet, face, upper arms), rash which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Benadryl helped it get better, but after it wears off the rash comes back and it gets worse. It had spread to different areas. Sometimes, it will be really bad on her knees, then other times really bad on her elbows or hips. Her hips were bad last night. Now it is on the bottom of her feet and on her knees again. She asked if these were something that have been previously reported. All of these symptoms, besides the rash, she felt like she had the flu. It knocked her on her ass it was pretty terrible. But it went away and she felt better. It was a typical immune response so she would say it was not serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. Clinical outcome of events chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure was recovered on 11Jan2021, while for the other events was not recovered.
28 2021-01-28 injection site pruritus, injection site swelling, hives, injection site pain immediately developed a raised itchy welt to injection site that continues to get larger and is now ... Read more
immediately developed a raised itchy welt to injection site that continues to get larger and is now painful
28 2021-01-29 injection site pain Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye p... Read more
Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye pain when looking at light
28 2021-01-30 rash macular Pfizer COVID-19 Vaccine EUA Event Description: Felt light headed and slight numbness in tongue and t... Read more
Pfizer COVID-19 Vaccine EUA Event Description: Felt light headed and slight numbness in tongue and throat about 10 minutes post Covid-19 vaccine (Pfizer EL9261, exp. 5/1/21). History of vasovagal reactions. Also said numb tongue made her think of trouble swallowing. Given water, Benadryl 25mg PO, Zyrtec 10mg PO, and Famotadine 20mg PO and felt better. Heart: RRR without mrg Lungs: clear Skin: blotchy and slightly flushed in spots Throat clear No problems swallowing medications, also given Ginger Ale
28 2021-01-30 injection site redness, injection site swelling Red swollen area around site injection
28 2021-01-31 injection site warmth, injection site redness, injection site swelling, injection site pruritus, injection site pain 6 hours after shot Injection site swollen and red and hot to the touch. Also very itchy and painful.... Read more
6 hours after shot Injection site swollen and red and hot to the touch. Also very itchy and painful. Two days later lumps have formed in my neck and under my armpit. They are painful and movable. I am having an ultrasound in a few days on them.
28 2021-01-31 rash macular, rash, itchy skin, rash with redness After client received her COVID-19 Pfizer vaccination, client was sitting in the observation area of... Read more
After client received her COVID-19 Pfizer vaccination, client was sitting in the observation area of the vaccine clinic (as required after receiving the vaccination) and it was observed by the EMS person and Public Health Nurse that was there, that client was itching her forearms. Client had developed a red rash, starting on her arms and then her neck and chest (blotchy red). She complained of itching on her arms, neck and then her head. She reports she felt like she was "on a boat", feeling lightheaded. Client was taken to the emergency room where client reports she received IV Benadryl. Client reports that after being at the ER for 1.5 hours, her rash resolved and she no longer felt lightheaded. Reports no other symptoms after that.
28 2021-01-31 injection site discolouration I don't know when it formed, but on 1/31/21 I notice a white halo around the injection site on my le... Read more
I don't know when it formed, but on 1/31/21 I notice a white halo around the injection site on my left arm. There is no pain, it is very faint but clearly there.
28 2021-01-31 injection site pain Injection Site Pain & Headache
28 2021-02-01 vaccination site rash, vaccination site redness, rash with redness Skin rash/redness at injection site and in axilla on side of injection; Skin rash/redness at injecti... Read more
Skin rash/redness at injection site and in axilla on side of injection; Skin rash/redness at injection site and in axilla on side of injection; Skin rash/redness at injection site and in axilla on side of injection; This is a spontaneous report from a contactable other healthcare professional reported for a female patient. A 28-year-old female patient receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), intramuscular (anatomical location: arm left) on 19Jan2021 at 13:00 at SINGLE DOSE for covid-19 immunization. Patient's medical history included birth control. Concomitant medications included ethinylestradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) as birth control, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluticasone nasal spray, and probiotics. The patient previously took first dose of bnt162b2 (lot number: EH9899; expiration date not reported), intramuscular (anatomical location: left arm) on 29Dec2020 at 09:30 am for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior vaccination. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient has no allergies to medications, food, or other products. Facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. It was also reported that patient was not pregnant at the time of vaccination. On 20Jan2021 at 07:00, the patient experienced skin rash/redness at injection site and in axilla on side of injection. It was reported that no treatment was provided for the events. The events were assessed as non-serious. Outcome of the events was recovering.
28 2021-02-01 injection site rash, dry skin, injection site redness, hives, itchy skin elevated redness sort of like a rash around the injected area; rash came back in the injected area; ... Read more
elevated redness sort of like a rash around the injected area; rash came back in the injected area; it was itchy; my face was swollen and ears; my face was swollen and ears; hives on my face; skin was very dry; rash like; This is a spontaneous report from a contactable healthcare professional reporting for a patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 31Dec2020 at 14:00 (at the age of 28-years-old) as a single dose for Covid-19 immunization. Medical history included tuberculosis (TB) when younger and took medication for it from an unknown date. The patient was allergic to penicillin and breaks out in hives and a rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date after the vaccination, the patient experienced elevated redness sort of like a rash around the injected area for 2 days and then it went away, exactly a week later the rash came back in the injected area but did not spread and lasted another two days. On 14Jan2021 at 04:00 the patient experienced broke up in hives on face, face was swollen, and ears and it was itchy. The patient experienced skin was very dry and rash like but not itchy on an unknown date in Jan2021. Therapeutic measures were taken for the swelling face, ear swelling, hives and pruritis which included Benadryl for 2 days which helped the events go down. The clinical outcome of the event injection site erythema, swelling face, ear swelling, hives and pruritus was recovered; injection site rash, dry skin and rash were unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-02-03 rash A rash appeared two days after the 1st injection, mainly on stomach; This is a spontaneous report fr... Read more
A rash appeared two days after the 1st injection, mainly on stomach; This is a spontaneous report from a contactable nurse reporting for herself. A 28-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140), via an unspecified route of administration on 30Dec2020 07:00 AM at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 28 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included allergies to eggs, shellfish, peanuts. Concomitant medication included desogestrel, ethinylestradiol (APRI). On 01Jan2021 the patient experienced a rash appeared two days after the 1st injection, mainly on stomach. The event was reported as non serious and resulted in Doctor or other healthcare professional office/clinic visit. Treatment for the event included steroid cream. The event had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
28 2021-02-03 vaccination site pain FIrst dose was administered on 05Jan2021; Fever; Sore arm around injection site; swollen and sore ly... Read more
FIrst dose was administered on 05Jan2021; Fever; Sore arm around injection site; swollen and sore lymph nodes: neck and arm of of injection; swollen and sore lymph nodes: neck and arm of of injection; Indigestion; This is a spontaneous report from a contactable 28-year-old female consumer reporting for herself A 28 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3300) on 22Jan2021 at 08:15 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included Shellfish allergy and allergy to doxicicline. The patient received first dose of vaccine on 05Jan2021 at 03:00 PM on right arm, lot_number=Ej1685. On 22Jan2021 at 18:00 the patient experienced fever, sore arm around injection site, swollen and sore lymph nodes: neck and arm of injection Indigestion (as reported). At the time of the reporting the patient had not yet recovered from reported events.
28 2021-02-03 rash Rash (scaly spots appeared over the left upper extremity and back - this isn't an uncommon autoimmun... Read more
Rash (scaly spots appeared over the left upper extremity and back - this isn't an uncommon autoimmune response for this patient) Brain fog Word finding difficulties Suspected decreased seizure threshold - unclear if partial seizure was elicited Intense fatigue Increased sleep Treatment: monitored for 30 minutes status post vaccine injection without any notable concerns; routine observation and monitoring given seizure history Time course: Rash lasted for 1 week; Brain fog/word finding difficulties last fully for 10 days, then started to dissipate; Fatigue and increased sleep lasted 1 week
28 2021-02-03 vaccination site pain Soreness of injection site; This is a spontaneous report from a non-contactable other healthcare pro... Read more
Soreness of injection site; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via an unspecified route of administration in the right arm on 19Jan2021 at 06:15 P.M. (at the age of 28-years-old) as a single dose, dose 1 for COVID-19 vaccination. The patient had an allergy to nickel. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were unknown. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 06:30 PM, the patient experienced soreness of injection site. The patient did not receive any treatment for the events. The clinical outcome of soreness of injection site was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
28 2021-02-03 vaccination site pain fatigue; slight headache; nausea; sore arm (left); swollen lymph nodes -left arm; This is a spontane... Read more
fatigue; slight headache; nausea; sore arm (left); swollen lymph nodes -left arm; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at arm left on 30Dec2020 at single dose for COVID-19 immunization. On 20Jan2021, the patient experienced fatigue, slight headache, nausea, sore arm (left) and swollen lymph nodes (left arm). The patient outcome of the events was unknown.
28 2021-02-04 hives, itchy skin Hives; itching; shortness of breath; chest tightness; severe hip and low back pain; severe hip and l... Read more
Hives; itching; shortness of breath; chest tightness; severe hip and low back pain; severe hip and low back pain; headache; concomitant medications included mercaptopurine; concomitant medications included mercaptopurine; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular at right arm on 19Jan2021 at 15:00 at single dose for COVID-19 immunization. The patient medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient's concomitant medications included mercaptopurine, mirtazapine (REMERON), sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC). The patient previously took ADDERALL, HUMIRA and REMICADE and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at right arm on 30Dec2020 at 15:45 at single dose for COVID-19 immunization. On 20Jan2021 at 06:00, the patient experienced hives, itching, shortness of breath, chest tightness, severe hip and low back pain and headache. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine, EPI PEN, TORADOL, acetaminophen, DECADRON, DILAUDID. The patient outcome of the events was resolved with sequel.
28 2021-02-04 rash, dry skin, rash papular, rash with redness, itchy rash I received the 1st dose of the Pfizer COVID vaccine on December 17th at 0640. I first started notici... Read more
I received the 1st dose of the Pfizer COVID vaccine on December 17th at 0640. I first started noticing some discoloration on the right side of my neck in a patch on January 1st. Over the course of the next 3 days the area became more red, dry, raised (but still maculopapular), and spread from the right side of my neck around the back of my neck to the left side and then the front. The area was mildly itchy. I had not had any new exposures including no new shampoos, soaps, clothes, sprays, sheets, detergent, etc. I have never had a rash that looked like this, nor have I ever had a rash on my neck. At it's fullest, the rash was a large patch of red, dry skin on my right with small maculopapular circles scattered on the rest of my neck. Around January 6-7th, when I got the second dose, the rash began to spread down my sides. That area was more itchy than my neck. The rash appearance was very consistent, as was the distribution with what I have seen of pityriasis rosea in my patients where you start with a Herald patch somewhere and then the rash spreads to other parts of the body. In January I had sought out an appointment through a virtual healthcare. they were hesitant to start steroids so as not to interfere with my immune response. I started over the counter hydrocortisone. In the few hours after I put it on the rash would be less itchy, less dry appearing and less red, but still noticeably pink, then would return. The rash has finally completely dissipated as of February 3rd morning, so it was present for a little more than a month.
28 2021-02-04 injection site pain In the evening had chills, shaking, could not get warm, low grade fever, 01/13/2021next day all over... Read more
In the evening had chills, shaking, could not get warm, low grade fever, 01/13/2021next day all over body aches, 99.9 and then arm pain at injection site nausea and diarrhea 01/14/2021 nausea and diarrhea disappeared on 01/14 or 01/15/2021. Nausea and diarrhea with first dose for two days.
28 2021-02-04 vaccination site itchiness, vaccination site redness, rash, vaccination site rash red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccin... Read more
red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs; This is a spontaneous report from a contactable nurse, reporting for herself. A 28-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 15Jan2021 at 11:00 (at the age of 28 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included crohn's disease from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ustekinumab (STELARA), sertraline, imipramine, colestipol, and B12, all from an unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination, The vaccine was given at a Hospital. On 15Jan2021 at 13:30, the patient experienced red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included Medrol dose pack. The clinical outcome of red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
28 2021-02-07 hives, itchy skin, redness Hives, Benadryl and Allegra, itchy, red welts all over my body except for my back, hands, face, lowe... Read more
Hives, Benadryl and Allegra, itchy, red welts all over my body except for my back, hands, face, lower legs, and feet.
28 2021-02-07 hives Urticaria 36 hours after.
28 2021-02-07 itchy skin Usual tiredness & adverse effect on PRN medication. I take sumatriptan for onset of migraine attacks... Read more
Usual tiredness & adverse effect on PRN medication. I take sumatriptan for onset of migraine attacks. Ever since I received the 1st dose on 1/22/21, when I take this medication, my face starts to itch & has a tingling sensation (pins & needles feeling). I have been taking this medication for 10yrs & not once have I ever had this kind of reaction. I am a little scared.
28 2021-02-07 itchy rash itching rash, tingling and warming sensation in arm radiating down within 15 min of shot. Pt has his... Read more
itching rash, tingling and warming sensation in arm radiating down within 15 min of shot. Pt has history of several allergic reactions to foods and medications. Stated that this felt like a similar reaction. Provided OTC Benadryl and patient stated that it resolved fairly quickly after initial dose, but had to continue w/ Benadryl for 2 days afterwards otherwise rash would reemerge.
28 2021-02-09 itchy skin, skin peeling, rash with redness, rash Developed rash. Started as 3 spots on lower abdomen, then over the course of the week developed more... Read more
Developed rash. Started as 3 spots on lower abdomen, then over the course of the week developed more spots on abdomen, under left arm, under right breast, and on back.; They itch when touch; Patient developed rash/They are raised, erythematous spots with scaling in the middle; They are raised, erythematous spots with scaling in the middle; This is a spontaneous report from a contactable Other HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. EL3302, expiry date not reported), via an unspecified route of administration on left arm on 10Jan2021 at a single dose for covid-19 immunization. Medical history included pollen allergy. The patient was not pregnant. Concomitant medication included fluoxetine (FLUOXETINE), ethinylestradiol, ferrous fumarate, norethisterone acetate (HAILEY 24 FE); both on unspecified dates for unspecified indications. The patient had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot no. EJ1685, expiry date not reported) on 20Dec2020 on left arm for Covid-19 immunization. On 12Jan2021, the patient developed rash. Started as 3 spots on lower abdomen, then over the course of the week developed more spots on abdomen, under left arm, under right breast, and on back. They are raised, erythematous spots with scaling in the middle. They itch when touched. No ulceration, no oozing. The spots are larger and more red now than when it first began. The patient had nasal swab on 17Jan2021, and it was negative. Outcome of the events was not recovered. The vaccine was given on school or student health clinic. No other vaccines were given in four weeks. No follow-up attempts are possible. No further information is expected.
28 2021-02-09 rash, skin warm I had a fever, chills, headache, and fatigue. A week later, I'm still not feeling 100%. The scariest... Read more
I had a fever, chills, headache, and fatigue. A week later, I'm still not feeling 100%. The scariest reaction was a rash that broke out all over my chest. I also had one on my forehead. It looked like lacerations and I still have marks left behind. The rash on my chest was very hot and I had trouble breathing at night. I took pictures.
28 2021-02-09 rash with redness Left side of body felt very warm and felt like it was melting; red rash on left side face, neck, che... Read more
Left side of body felt very warm and felt like it was melting; red rash on left side face, neck, chest, arm; Facial spasms; Fever; Confusion/lightheaded; Confusion/lightheaded; Palpitations; Feeling of being unwell; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm single dose for COVID-19 immunization on 22Jan2021, 05:45 PM, at 28-year-old. Medical history included: COVID-19. No allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included: daily vitamins, lisdexamfetamine mesilate (VYVANSE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient left side of body felt very warm and felt like it was melting. The patient had red rash on left side face, neck, chest, arm. The patient had facial spasms, fever, confusion/lightheaded, palpitations, feeling of being unwell, fatigue. All on 22Jan2021, 06:45 PM, and was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit, no treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving. Information on the lot/batch number has been requested.
28 2021-02-09 rash macular, skin burning sensation, itchy rash Red splotchy rash on left and right upper flank areas; itching and burning associated with rash; itc... Read more
Red splotchy rash on left and right upper flank areas; itching and burning associated with rash; itching and burning associated with rash; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 29-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm, at the age of 28-years, on 21Jan2021 15:30 (03:30 PM) at a single dose as Covid vaccine. Medical history included cyclic vomiting syndrome. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had known medication allergies including diphenhydramine hydrochloride (BENADRYL), propranolol hydrochloride (INDERAL), sumatriptan succinate (IMITREX), metoclopramide (REGLAN), and benzatropine mesilate (COGENTIN). The patient experienced red splotchy rash on left and right upper flank areas, itching and burning associated with rash on 23Jan2021. Treatment was not received for the events. She had no Covid prior to vaccination. She has not had Covid tested post vaccination. The outcome of the events was not recovered.
28 2021-02-09 itchy skin, rash rash worsened following the 2nd injection. Rash then spread all over body and increased in size; Ext... Read more
rash worsened following the 2nd injection. Rash then spread all over body and increased in size; Extremely itchy; Diagnosed as possible pityriasis; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received 2nd dose of BNT162B2 (lot number: EL3249), via an unspecified route of administration in left arm on 20Jan2021 13:45 at single dose for covid-19 immunisation. Medical history known allergies: eggs, shellfish, peanuts. Concomitant medication included desogestrel, ethinylestradiol (APRI). The patient previously received 1st dose of BNT162B2 (lot number: EL0140) in left arm on 30Dec2020 for COVID-19 immunization and experienced rash/mainly on stomach two days after the 1st injection. On an unspecified date of Jan2021, the rash worsened following the 2nd injection. Rash then spread all over body and increased in size. Extremely itchy. Diagnosed as possible pityriasis. Treatment steroid cream received for the adverse events. The outcome of events was not recovered. This case was reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
28 2021-02-10 hives, itchy skin, rash After first shot on 12/24/2020, I noticed a small rash on my right arm that was quite itchy. After m... Read more
After first shot on 12/24/2020, I noticed a small rash on my right arm that was quite itchy. After my second dose on 1/14/2021, my rash and itching grew and now I am covered from my neck down to my ankles. I am covered in a red rash/hives, and this is incredibly itchy.
28 2021-02-10 injection site pain After my 2nd dose administration, I sat in an observation tent with 4 resident doctors. This is prot... Read more
After my 2nd dose administration, I sat in an observation tent with 4 resident doctors. This is protocol at my hospital to assess for any adverse reactios. About 10 minutes later, I started to feel both of my arms (from should all the way to tips of my fingers) start to get tingly with an intense vibrating sensation. I tried to calm myself down, however numbness began to occur to both BUE seconds after. Next thing that happened, bilateral fingers became visually contracted however numb and I could not move my fingers. I also got a tingly/prickly sensation to my cheeks all the way down to my chin after the hand numbess. The resident doctors quickly took me by wheelchair to a private room where they checked my vital signs. BP was elevated with systolic in 190's, HR around 120s, and my limbs were all cold. By this time it was around 6pm and they were trying to calm me down as I started to have a panic attack. My parents came to pick me up at 7pm when my vitals were stable. I rested at home, and the contraction to my fingers/numbess did not subside until 8:30pm. The following day, my left arm (injection site) had a soreness level of 9/10. Tylenol was used to relieve pain.
28 2021-02-10 hives I experienced hives on my face that same day in the evening around 7:00pm-7:30pm. I applied aloe ver... Read more
I experienced hives on my face that same day in the evening around 7:00pm-7:30pm. I applied aloe vera on face and took Benadryl, after 5-10min my face was cleared.
28 2021-02-10 rash macular, injection site redness, injection site pain Moderate soreness around injection site for about 24 hours, red splotches near injection site for ab... Read more
Moderate soreness around injection site for about 24 hours, red splotches near injection site for about 12 hours
28 2021-02-11 injection site swelling, injection site redness Fever Shortness of breath Chills Unable to move my arm My arm was swollen and red around the a... Read more
Fever Shortness of breath Chills Unable to move my arm My arm was swollen and red around the area where the vaccine was injected. Sore throat
28 2021-02-14 hives 12 hours after her second COVID-19 vaccine, the patient experience shortness of breath that seemed t... Read more
12 hours after her second COVID-19 vaccine, the patient experience shortness of breath that seemed to be an asthma attack (which she hasn't had in 10 years). She used a short acting inhaler. Then she experienced hives 1 hr after shortness of breath which she treated with benadryl. She was asymptomatic by the morning and has continued to be stable since event.
28 2021-02-14 rash Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pal... Read more
Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-02-14 itchy skin Itchiness throughout body, significantly in feet and legs
28 2021-02-14 injection site pruritus Patient received the Pfizer-BioNTech COVID-19 Vaccine at 1734. Reported onset of symptoms at 1735 wi... Read more
Patient received the Pfizer-BioNTech COVID-19 Vaccine at 1734. Reported onset of symptoms at 1735 with immediate itching at injection site. Benadryl 25 mg po given and observed for 40 minutes. Felt better after further observation and left the clinic.
28 2021-02-14 hives, rash Rashes/hives on left wrist, left elbow crease, upper right collar bone, right bicep, right elbow cre... Read more
Rashes/hives on left wrist, left elbow crease, upper right collar bone, right bicep, right elbow crease, back of the neck, various locations on the back, largest rashes on left and right inner thighs.
28 2021-02-15 hives lip tingling, throat tightness, dyspnea, facial hives
28 2021-02-16 hives Received 1st dose COVID-19 Vaccine at 1705. Ambulated to restroom and noted hives developed on tors... Read more
Received 1st dose COVID-19 Vaccine at 1705. Ambulated to restroom and noted hives developed on torso and legs with heaviness in chest; denies difficulty breathing. Received MD evaluation in ED. Benadryl 50mg IV and Decadron 10mg IV. Discharged home in stable condition. Instructed NOT to receive 2nd COVID-19 Vaccine. Home with Prednisone and Epi-pen PRN.
28 2021-02-18 itchy skin, rash A hour post vaccine: rash and itchy all over my body (10 am) At night: fever, chills and bones pain.... Read more
A hour post vaccine: rash and itchy all over my body (10 am) At night: fever, chills and bones pain. Dizzy. 11:00 am next day (actual moment): still with fever, dizziness and fever
28 2021-02-18 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA injected into left arm at 10:15 am on 17 Feb. Soreness at the i... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA injected into left arm at 10:15 am on 17 Feb. Soreness at the injection site was the only symptom immediately following the injection. At about 3:00 am the next morning, I experienced extreme nausea and chills. I fainted when I tried to get out of bed to go to the restroom. All of 18 Feb, I experienced the following symptoms: headache/migraine, fatigue, dizziness, loss of appetite, muscle aches/soreness, fever, and severe pain in my left arm. As of today, 19 Feb, I am experiencing headache, lightheadedness, and mild pain my left arm.
28 2021-02-21 itchy skin 10 minutes after vaccine administration, pt developed significant and generalized pruritis, more so ... Read more
10 minutes after vaccine administration, pt developed significant and generalized pruritis, more so over her right arm, but over both upper extremities. She did not develop any signs of respiratory compromise or hypotension, so was given 50mg Benadryl and her itching improved.
28 2021-02-22 injection site pain Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection s... Read more
Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue
28 2021-02-22 injection site pain Fever, chills, body ache, nausea, tiredness and fatigue for 36h, sore site of injection for 4 days
28 2021-02-23 injection site pain About 30 hours following injection, observed slow to full facial pain on the right side of face and ... Read more
About 30 hours following injection, observed slow to full facial pain on the right side of face and head. Face was mildly inflamed and in pain for approximately 6 hours, then gradually the pain and inflammation subsided. No ibuprofen or other pain relievers were taken at the near the time of adverse event. Ibuprofen (400 mg) was taken at approximately 9 pm the previous evening to reduce arm pain/pain at the injection site.
28 2021-02-23 injection site tingling Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered,... Read more
Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered, No EMS, resolved during extended observation.
28 2021-02-23 pain of skin Pain began as a "crick" in the left side of the neck two days after receipt of second covid vaccine.... Read more
Pain began as a "crick" in the left side of the neck two days after receipt of second covid vaccine. It has now been three weeks and pain has been continuous in the left shoulder and left neck. Pain radiates down the arm and up into the ear, making the ear hurt and making it painful to swallow. The skin is also tender/painful to touch in the same areas, as if nerve damage has occurred. Swelling is visible in the upper back and neck.
28 2021-02-23 injection site pain Painful arm (could not lift arm) for 2 days Cough Fever Body aches/chills Loss of smell/taste Diz... Read more
Painful arm (could not lift arm) for 2 days Cough Fever Body aches/chills Loss of smell/taste Dizziness Headache Extreme fatigue Neck pain These symptoms lasted approximately 9 days
28 2021-02-24 itchy skin Itchy, all over.
28 2021-02-25 injection site warmth, injection site redness, injection site pruritus, hives 4.5 inch diameter warm red itchy welt appeared day 8 after vaccination at injection site.
28 2021-02-25 hives Hives all over from scalp to toes for over six days; This is a spontaneous report from a contactable... Read more
Hives all over from scalp to toes for over six days; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9262), via an unspecified route of administration in left arm on 22Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included allergies to Sulfa. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19 Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and ethinylestradiol, etonogestrel (NUVARING). The patient experienced hives all over from scalp to toes for over six days on 22Jan2021 22:30. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.
28 2021-02-27 injection site reaction Muscle spasms at the site of vaccination
28 2021-02-28 vaccination site pain soreness at the injection site; Headache; elevated temperature (100.2 F); This is a spontaneous repo... Read more
soreness at the injection site; Headache; elevated temperature (100.2 F); This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration in left arm on 26Jan2021 08:30 at a single dose for covid-19 immunization. Medical history was reported as none. There was no other vaccine administered to the patient in four weeks. No known allergies. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 27Jan2021 at 07:00, patient experienced soreness at the injection site, headache and elevated temperature (100.2 F). Outcome of the events was unknown. Patient was given the vaccine in a workplace clinic. The patient has not tested with Covid since vaccination. Information about Batch/Lot number has been requested.
28 2021-03-01 bruising Pfizer-BioNTech COVID-19 Vaccine: Thirty minutes after receiving vaccination developed trunk flushin... Read more
Pfizer-BioNTech COVID-19 Vaccine: Thirty minutes after receiving vaccination developed trunk flushing, nausea, and tiredness. Flushing quickly resolved but patient reports nausea, abdominal pain, mild headache, and tremors since vaccination. Six days after vaccination noticed hip bruising in the absence of falls or trauma and a cut on the hand that bled more than expected. No respiratory distress or rash noted on exam. Vital signs all within normal ranges. Patient left clinic visit stable and advised to avoid non-steroidal anti-inflammatory medications.
28 2021-03-01 hives, skin warm patient reported that approximately 3 hours after receiving the vaccine her face broke out in hives,... Read more
patient reported that approximately 3 hours after receiving the vaccine her face broke out in hives, and was hot to the touch, this lasted all night but went away the following day, patient was deferred from the 2nd shot until cleared by her physician
28 2021-03-02 rash rash on right breast; swollen and painful axillary lymph node; swollen and painful axillary lymph no... Read more
rash on right breast; swollen and painful axillary lymph node; swollen and painful axillary lymph node; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: ek5730; expiration date: unknown) at the vaccination age of 28-year-old via an unspecified route of administration in the right arm on 13Jan2021 10:00 at a single dose for covid-19 immunisation. The patient medical history was not reported. The patient diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. Concomitant medication included duloxetine hydrochloride (CYMBALTA), ibuprofen (ADVIL) and birth control medication. The patient first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: ek5730) at the vaccination age of 28-year-old via an unspecified route of administration in the right arm on 13Jan2021 10:00 at a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. On 15Jan2021, the patient had rash on right breast, and swollen and painful axillary lymph node. The patient did not receive treatment for the adverse events. The events were non-serious, and the events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
28 2021-03-03 injection site swelling, injection site pain Zero adverse effects after first dose. Roughly 10 hours after second dose, I had some body aches, in... Read more
Zero adverse effects after first dose. Roughly 10 hours after second dose, I had some body aches, injection site soreness, and headache. I took 650mg of acetaminophen. Roughly 12 hours after the second dose I had increased body aches, injection site soreness and swelling, worsening headache, and nausea. Roughly 18 hours after the second dose, I had chills, a low grade fever, worsening body aches, worsening headache, nausea and vomiting. I took 975mg of acetaminophen. At this time, 27 hours after the second dose, I have body aches, exhaustion, and lack of appetite. I have not vomited in 6 hours and temperature is 99.3.
28 2021-03-03 vaccination site pain, redness, vaccination site redness back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection s... Read more
back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection site; redness at the injection site for 3 days after; Stomach pain; Nausea; Headache; redness in left arm; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, intramuscularly on 25Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy diagnosed a couple of years ago, ongoing food allergy she has had allergies to tree nuts, peanuts, shellfish, and sesame seeds her whole life. Concomitant medications include an unspecified product. The patient previously received the first dose of BNT162B2 on 04Jan2021 at around 12:30-13:00, intramuscular injection in left arm Lot number: EL1284 for COVID-19 immunization and experienced soreness. The patient also reported to have received a flu shot on an unspecified date in 2019 and had soreness. The patient reported to have received the second dose Monday, 25Jan2021 at 14:00 and had redness in her arm which recovered completely on Thursday 28Jan2021. On Tuesday night, 26Jan2021, the patient was sick with stomach pain, nausea, and a bad headache that went away by Wednesday, 27Jan2021. She was less sore on Wednesday, 27Jan2021, and she worked out, she did yoga, she got horrible pain at the injection site which started on 28Jan2021, Thursday morning in the middle of the night and stopped by the end of the day. States it went away with pain medication. The pain is nothing like she experienced before. The vaccine site area has been a little sore. She did yoga again last night and the same thing happened, she got pain at the injection site that was horrible. Reports the back of her left shoulder is very painful, it is sharp pains that do not go away on unspecified date. Took some Tylenol for pain at the injection site and left shoulder, that didn't help, took Aleve, heat and ice and by the end of the day, patient was fine. Just some soreness until middle of the night again, same reaction as before. Reports she had redness at the injection site 3 days after on 28Jan2021. She forgot to mention that she had weakness in her left arm that started 28Jan2021 and then she was fine and the weakness started again today. The outcome of the events redness in her arm was recovered on 28Jan2021, sick with stomach pain, nausea, and a bad headache was recovered on 27Jan2021, pain at the injection site, back of her left shoulder is very painful, weakness in her left arm was not recovered, while for the rest of the events was unknown. The patient was vaccinated in a hospital.
28 2021-03-04 injection site pain "the next day [after vaccination] the injection site was extremely sore and the pain went up to my n... Read more
"the next day [after vaccination] the injection site was extremely sore and the pain went up to my neck and down into my hand. From what I heard this is pretty normal so I had no concerns. Over the next couple days the injection site pain was gone along with the neck pain but the wrist/hand pain persisted. It?s now been a week since the pain started and my wrist/hand/forearm are still really sore/achy. I?ve been icing it multiple times a day but the pain persists. It?s especially bad when typing or doing any repetitive motions with my hand. "
28 2021-03-04 injection site pain Fever, muscle aches, chills, sweats, nausea, vomiting, fatigue, tight chest, cough, soreness in shou... Read more
Fever, muscle aches, chills, sweats, nausea, vomiting, fatigue, tight chest, cough, soreness in shoulder (where I got vaccinated). Nausea lasted about 4 hours, fever lasted about 6-7 hours, aches and sweats lasted about 15 hours, fatigue lasted about 40 hours, chest tightness and mild cough lasted 48 hours and sore shoulder is continuing beyond 48 hours but slowly improving with time
28 2021-03-04 itchy rash, rash, injection site reaction, rash with redness, rash maculo-papular Pruritic red maculo-papular rash in injected are began same evening and progressed to other extremit... Read more
Pruritic red maculo-papular rash in injected are began same evening and progressed to other extremities and trunk over 96 hours. No urticaria, no SOB, no edema. Itching resolved with adequate doses of diphenhydramine followed by rash resolution.
28 2021-03-06 vaccination site itchiness, vaccination site swelling, vaccination site redness Raised, round, red mark at vaccination site. Slightly itchy.
28 2021-03-07 injection site redness, injection site pain, injection site swelling 18-40 hours after getting vaccine: sensitivity to light headache with light activity (walking more t... Read more
18-40 hours after getting vaccine: sensitivity to light headache with light activity (walking more than 5 minutes) fatigue muscle/joint pain injection site swelling and redness soreness at injection site (lasting 48 hours +)
28 2021-03-07 redness, hives I noticed some hives on my arms, face, and chest area at around 3 or 4pm, and next day it was still ... Read more
I noticed some hives on my arms, face, and chest area at around 3 or 4pm, and next day it was still present but a little red. It?s better but still here.
28 2021-03-08 rash Pfizer-BioNTech COVID-19 Vaccine EUA I received the Pfizer vaccine a week ago from today and I belie... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I received the Pfizer vaccine a week ago from today and I believe I am having a mild allergic reaction to it. I have two very itchy bumps on each of my ankles, one under my right knee, and two on my left arm. The bumps formed almost immediately after getting the shot and was itching before I made it home. The bumps on my ankles are now larger than they were last week. The one under my knee just got there within the last few days. The itching has seem to have gotten worse because it woke me up out of my sleep over Monday night.
28 2021-03-08 rash with redness, rash, hives, itchy skin Rash, Red patches, Hives from waist up, SEVERE itching that lasted 1 hour
28 2021-03-08 injection site pruritus, injection site redness, injection site mass Red bump appeared and where itching at injection beginning 3/6/21 At 7am And ending 3/8/21 around 43... Read more
Red bump appeared and where itching at injection beginning 3/6/21 At 7am And ending 3/8/21 around 430pm. I took benadryl to relieve temporarily until it went away on its own.
28 2021-03-08 injection site pruritus, injection site redness, injection site swelling Redness, swelling, and itching at site of injection starting 5 days after injection and ending 6 day... Read more
Redness, swelling, and itching at site of injection starting 5 days after injection and ending 6 days after injection.
28 2021-03-09 rash macular, itchy skin, rash, rash papular "She is a 28 year-old female calling today with a chief complaint of a rash. Her symptoms started ab... Read more
"She is a 28 year-old female calling today with a chief complaint of a rash. Her symptoms started about three days ago. She got her first Pfizer covid-19 vaccine last Thursday, 5 days ago. 2 days later she started to develop some itching on the bottom of her foot and then shortly after started to develop a blotchy rash on the foot. She woke up today and now has a rash over the majority of her body, it is under her arms, on her chest, her knees, her sides, upper back, inguinal area and legs. She is not having any trouble breathing or swallowing. There is no chance she is pregnant. The rash is not itchy except for the small area on her foot. She took Benadryl once the first night she had some itching which helps."
28 2021-03-09 vaccination site pain Muscle aches (back); Injection site pain; Headache; Flushing in face; Brain fog; This is a spontaneo... Read more
Muscle aches (back); Injection site pain; Headache; Flushing in face; Brain fog; This is a spontaneous report from a contactable other hcp (reporting for herself) A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration single dose on 06Feb2021 10:15 (at the age of 28) left arm for covid-19 immunisation. The first dose (lot# EL12849) was taken on 15Jan2021 10:15 am, left arm. The patient medical history was not reported. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced muscle aches on 06Feb2021 19:00, injection site pain on 06Feb2021 19:00, headache on 06Feb2021 19:00, flushing in face on 06Feb2021 19:00, brain fog on 06Feb2021 19:00. No treatment received. The events outcome was not recovered.
28 2021-03-10 redness Patient received her 2nd dose of Pfizer Covid-19 vaccine, Lot #EN6199, in her left deltoid on 3/11/... Read more
Patient received her 2nd dose of Pfizer Covid-19 vaccine, Lot #EN6199, in her left deltoid on 3/11/2021 at approximately 9:24am. Patient disclosed to nurse and medic at vaccination clinic that she had allergies to peanuts and eggs and would need to wait in the parking lot longer than usual. Nurse and medic confirmed this and advised she wait a minimum of 30 mins but longer if she felt necessary. While waiting in the parking lot, at approximately 10:25am, patient began to have shortness of breath and made the medics aware. Patient also had facial redness and nausea. Medics administered 50mg of Benadryl , 0.3ml Epinephrine, and started IV with IV fluids. Patient was transported to Medical Center.
28 2021-03-10 itchy skin Reports itching to face & arms beginning at 1224 Administered 25mg Diphenhydramine with relief. Clea... Read more
Reports itching to face & arms beginning at 1224 Administered 25mg Diphenhydramine with relief. Cleared to leave at 1310 with reported improvement of itching.
28 2021-03-10 itchy skin Shortly after receiving the shot at work, I developed worsening dizziness as well as a headache and ... Read more
Shortly after receiving the shot at work, I developed worsening dizziness as well as a headache and internal tremors, which resolved. I later developed generalized itching, worse on the back of my hands and feet, which resolved. The following day, I developed palpitations while at rest and mild shortness of breath. I also had a brief bout of nausea, which resolved, but I still have palpitations and mild shortness of breath.
28 2021-03-12 injection site redness, injection site swelling, injection site warmth Large red raised area at injection site, warm to the touch. Fever of 99.8, muscle and body aches, fa... Read more
Large red raised area at injection site, warm to the touch. Fever of 99.8, muscle and body aches, fatigue, migraine, un-productive coughing, chest tightness, difficulty breathing.
28 2021-03-12 injection site pain Nausea, exhaustion, lightheaded/ dizziness, sore arm around injection site, light headache. lots of ... Read more
Nausea, exhaustion, lightheaded/ dizziness, sore arm around injection site, light headache. lots of rest and hydration. symptoms lasted for 48 hours, only beginning the morning following the injection, (sore arm began right away).
28 2021-03-13 bruising First dose: Had a very slightly sore arm a few hours after injection through the following morning. ... Read more
First dose: Had a very slightly sore arm a few hours after injection through the following morning. Then had a very slight headache for a couple hours. Then the day after that my neck was very sore on the side the vaccine was given. I watched TV on my laptop and had my elbows on my thighs for maybe 30 minutes and I often watch TV like this. When I went to the bathroom, I saw my thighs had multiple bruises where my elbows were (3 spots) while I was watching TV. The bruises and sore neck lasted another 2 days and I was fatigued more quickly during this time. After that I was fine, though 1 bruise spot still remains today 11 days after vaccination. The easy bruising and lasting bruising is not normal for me. I have dark color skin and also rarely bruise.
28 2021-03-14 rash with redness, itchy skin Itchy swollen fingers and palms the following morning (Thursday, 3/11). Red itchy bumps (hives?) on... Read more
Itchy swollen fingers and palms the following morning (Thursday, 3/11). Red itchy bumps (hives?) on left wrist, then later on right wrist. Heels and feet had same reaction on Friday. I took Benadryl and was OK for all of Saturday. Today (Sunday, 3/14), I broke out the same rash but one my face, mostly around my jaw and hair line, and my neck. Some coughing and wheezing, which I had not been experiencing prior
28 2021-03-14 injection site pain Strong pain in deltoid muscle beginning the evening of the first injection (3/12) and the day after ... Read more
Strong pain in deltoid muscle beginning the evening of the first injection (3/12) and the day after (3/13). Impossible to sleep on that arm, difficult to lift arm, severe pain when touched. Diminished pain 3/14-3/15.
28 2021-03-15 shingles Shingles; This is a spontaneous report from a contactable consumer or other health professional. A 2... Read more
Shingles; This is a spontaneous report from a contactable consumer or other health professional. A 28-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Manufacturer: Pfizer/BioNTech; Lot: EN5318) via an unspecified route of administration on 11Feb2021 in Arm Right at single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergy (seasonal allergies) from an unknown date and unknown if ongoing. Historical vaccination included at age of 28 years first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Manufacturer: Pfizer/BioNTech; Lot: EL3247) on 21Jan2021 in Left arm at single dose for COVID-19 immunisation. Concomitant medications included cetirizine and fluticasone propionate (FLONASE) taken for an unspecified indication, start and stop date were not reported. On 14Feb2021, The patient experienced shingles. The action taken in response to the event for BNT162B2 was not applicable. Therapeutic measures were taken as a result of shingles. The outcome of event was recovering.
28 2021-03-16 injection site swelling Nausea, vomiting and bodyaches. Employee states her Left arm is swollen from injection site down to... Read more
Nausea, vomiting and bodyaches. Employee states her Left arm is swollen from injection site down to her hand. Arm is very painful to move.
28 2021-03-17 itchy skin 1450- pt requested assistance for tachycardia, tingling lips and dizziness. Requesting benadryl, 50m... Read more
1450- pt requested assistance for tachycardia, tingling lips and dizziness. Requesting benadryl, 50mg given PO. VS 128/54, P90, 20R, 98% sat. 1500- increased dizziness, throat tingling. VS 130/89, 104P, 24R, 98% 1508- increased throat tingling, "hard to breath" declines epi or EMS to be called. 1511- self-administered epi pen, EMS notified. 1516- remains light-headed/dizzy, resp adequate at 22/min, O2 sat 98% 1524- speaking clearly, remains fully conscious. Resp regular. Lungs CTA, MM pink. VS 130/70, 83P, 20 R, 98%sat 1530- Await EMS arrival. Pt able to easily talk on phone with family member. Still c/o itchy throat and lips. 1535- EMS here, pt escorted out building with EMS at 1537.
28 2021-03-17 injection site swelling, rash I had chills, body aches; headaches; I felt feverish but I don' t know if I had a fever. Body aches ... Read more
I had chills, body aches; headaches; I felt feverish but I don' t know if I had a fever. Body aches were really intense - I didn't sleep the whole night. I had swelling a little on my arm - at injection site. My arm was sore. In general, my body was really sore and I couldn't get up from bed for 24 hours. I still had a bit of a headache and chills after the 24 hours so I stayed home from work 48 hours. I have been seen by a doctor -after the second vaccine, I had a flare up with my rash on my face (had been experiencing a rash on face prior to vaccine but this was a flare). My face flare up was that I broke out in a rash after finishing doxycycline. Didn't put me on another antibiotic because they wanted to wait and see with the rash - and the tests. Flare up - I couldn't eat; painful to wear a mask to work; couldn't sleep on my face. I was put on doxycycline again - on March 10th or 11th again because I couldn't handle the pain anymore. And it is getting refilled for another round. I have had to take a leave a absence from work the last two weeks.
28 2021-03-19 injection site swelling, injection site redness, injection site pain, injection site rash Circular, swollen, painful red rash around the injection site. About three inches in diameter.
28 2021-03-19 redness SWOLLEN, RED, PAINFUL LEFT ARM FOLLOWING ADMINISTERATION OF VACCINE.
28 2021-03-20 hair loss 1 week after my second dose I start developing hair loss, specifically alopecia Areta; 1 week after ... Read more
1 week after my second dose I start developing hair loss, specifically alopecia Areta; 1 week after my second dose I start developing hair loss, specifically alopecia Areta; This is a spontaneous report received from a contactable 28-year-old female nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: El1284, dose number=2) via an unspecified route of administration on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: Ej1685, dose number=1) via an unspecified route of administration on 18Dec2020 10:30 AM at single dose for Covid-19 immunization. As per the adverse event description, one week after her second dose on 15Jan2021, she started developing hair loss, specifically alopecia Areta resulted in doctor or other healthcare professional office/clinic visit. She took unspecified steroid injections to scalp. The outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
28 2021-03-21 injection site swelling Localized swelling to right arm at the site of the injection, beginning the day after injection.
28 2021-03-21 injection site bruising Severe bruises on right arm at injection site; think it may be a popped blood vessel
28 2021-03-22 redness Erythema of bilateral facial cheeks and right neck. Of note, patient had mild facial erythema after ... Read more
Erythema of bilateral facial cheeks and right neck. Of note, patient had mild facial erythema after first vaccine dose. Received Benadryl 50 mg pO.
28 2021-03-23 redness 815am - notice entire left arm is swollen and red, a few minutes later extreme nausea, dizziness, ch... Read more
815am - notice entire left arm is swollen and red, a few minutes later extreme nausea, dizziness, chills, which lasted about 20 minutes. Fatigue and aches followed which slowly faded and were gone by about 4pm
28 2021-03-23 injection site pruritus, hives, itchy skin Facial swelling, itchiness around injection site, itchiness of ankles, wrists, face, hives
28 2021-03-24 redness About 30 minutes after receipt of the first dose of the Pfizer COVID vaccine, my upper lip was sligh... Read more
About 30 minutes after receipt of the first dose of the Pfizer COVID vaccine, my upper lip was slightly swollen on the same side as where I received the vaccine (left), and I had redness in my face for about 1.5 to 2 hours. I also had a slight lump in my throat 15-30 minutes after receipt. I never felt like I was in danger or needed immediate medical attention, and the symptoms subsided without medication.
28 2021-03-24 hives Hives which responded to Benadryl
28 2021-03-24 rash feeling faint and hot; feeling faint and hot; the patient began to experience lightheadedness; Syste... Read more
feeling faint and hot; feeling faint and hot; the patient began to experience lightheadedness; Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable other health care professional. A 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206 and expiry date was not provided), via an unspecified route of administration on 12Mar2021, as SINGLE DOSE for COVID-19 immunisation. Medical history and concomitants were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The reporter stated that, during her 15-minute waiting period after the injection, the patient began to experience light-headedness and feeling faint and hot. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, facial swelling, lip swelling and tongue swelling. The patient received water, snacks and ice packs as the treatment. On an unknown date in Mar2021 the patient had differential diagnosis systemic reaction (hypoglycemia, hypotension, generalized rash). The reporter stated that that the patient having improvement of symptoms after observation in medical bay for 40 mins. She was to be taken home by her father who was able to come in to pick her up. The reporter stated that the patent wheeled to front by this provider and able to stand and walk assistance to car and she was monitored symptoms at home and follow up with PCP as needed. Outcome of the events was recovering. No follow-up attempts are possible. No further information available.; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
28 2021-03-25 injection site pain, injection site warmth, injection site swelling 12 hours post vaccine: Developed fatigue, nausea, chills, body aches. No fever recorded. Injection... Read more
12 hours post vaccine: Developed fatigue, nausea, chills, body aches. No fever recorded. Injection site felt hot and swollen but did not appear swollen. 18 hours post vaccine: Took 1000 mg tylenol and went back to sleep 20 hours post vaccine: Woke up feeling better, went to work 24 hours post vaccine: Developed bad headache, fatigue and nausea again 30 hours post vaccine: Took 1000 mg tylenol and 500 mg ibuprofen 32 hours post vaccine: Almost all symptoms gone, only mild residual injection site soreness still present
28 2021-03-26 injection site pain 13 weeks 6 days at time of injection, 14 weeks 0days at onset of symptoms. Body aches and chills sta... Read more
13 weeks 6 days at time of injection, 14 weeks 0days at onset of symptoms. Body aches and chills started at 1am. Vomiting started at 2am and last until 4p. Was unable to keep food or liquids down during that period. Had highest fever of 100.7 F, as well as nausea, body aches, chills, fatigue and severe pain at injection site. Nausea and fatigue continued into day 2 after getting vaccine (3/27).
28 2021-03-27 injection site pain From 9:30-11am significant decline from minimal symptoms to headache, body ache, soreness at site of... Read more
From 9:30-11am significant decline from minimal symptoms to headache, body ache, soreness at site of injection, fever (99.5°-100°). At 12pm took acetaminophen 325mg x2, reduced symptoms to manageable discomfort and no fever. Symptoms (incl fever) returned by 6pm, took another round of acetaminophen 325mg x2, which again helped through bedtime. Slept through the night, no fever next day.
28 2021-03-28 hives On 03/25/2021 client states she waited for her 30 minute waiting period following vaccine and about ... Read more
On 03/25/2021 client states she waited for her 30 minute waiting period following vaccine and about 10 minutes after leaving started to develop hives on hands/wrists/arms that continued spreading to sides and lower back. Client notified Health Dept on 03/26/2021, and client enouraged by writer to seek medical care. Writer spoke with client on 03/29/2021 and client states has not sought medical care or assessment. States she has no SOA, swelling, coughing, wheezing or any other s/s of adverse reactions. States hives remain.
28 2021-04-17 hives Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling wor... Read more
Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling worse; Some feverish feelings; Hives all over my body, especially on my face; Chills; Couldn't stop shaking; This is a spontaneous report from a contactable consumer (patient, self-reported). A 28-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732 and expiry date was not provided), via an unspecified route of administration, in arm left, on 26Mar2021, at 14:00 as single dose for COVID-19 immunisation. Patient medical history was not reported. She did not have any known allergies. Concomitant medications included estradiol valerate, progesterone and cyanocobalamin (VITAMIN B12). Patient stated that she first experienced some feverish feelings, chills and hives 30 minutes following her vaccination. She drove home from the hospital and was feeling a bit off, but mostly okay. By the time she got back, she was feeling worse, around 4 PM. By 5 PM she had broken out in hives all over her body, especially on her face, swelling her eyes significantly and having her tongue go somewhat numb, starting to make it difficult to swallow. She also had significant chills, and couldn't stop shaking, and ended up being admitted to the ER. After being given antihistamines, the swelling went down and eventually the chills stopped after monitoring in the hospital. The patient was hospitalized for the events on an unknown date in Mar2021. Treatment received for the events. The patient was not diagnosed with COVID prior vaccination. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. Outcome of the events was recovered on an unknown date in Mar2021.
28 2021-04-26 pain of skin Fever, chills, muscle aches, teeth chattering, painful to touch all over body, exhaustion. Starting ... Read more
Fever, chills, muscle aches, teeth chattering, painful to touch all over body, exhaustion. Starting around 11:30 pm. Fever and chills subsided around 3:00 am on 4/26. Muscle were sore and body aches until around 11:00 am 4/26. Tired and drowsy all day 4/26.
28 2021-04-27 itchy skin, injection site pruritus Itching near site of Injection. Itching then spread down the arm to the elbow area. Itching on neck... Read more
Itching near site of Injection. Itching then spread down the arm to the elbow area. Itching on neck and side of face. Itching also on back and legs. Itching persistent for 30+ minutes
28 2021-04-30 vaccination site pain injection site soreness; general body aches; upset stomach; This is a spontaneous report from a cont... Read more
injection site soreness; general body aches; upset stomach; This is a spontaneous report from a contactable consumer (patient's guardian). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 07Apr2021 at 16:15 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 17Mar2021 at 04:15 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient received other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 19:00, the patient experienced injection site soreness, general body, aches, upset stomach. No treatment was received for the adverse events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained
28 2021-05-04 hives Hives; This is a spontaneous report from a contactable consumer (patient's husband). A 28-year-old f... Read more
Hives; This is a spontaneous report from a contactable consumer (patient's husband). A 28-year-old female received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3247, expiration date May2021) via intramuscular administered in left arm on 08Feb2021 (at the age of 28 years old) as single dose for COVID-19 immunisation. The patient medical history included Chronic kidney disease (May2018), helps to lower protein in urine, iron was low, autoimmune disease, to stabilize the kidney. Patient got flu shot last year, months ago. Concomitant medications included Losartan50mg tablet twice a day by mouth used for chronic kidney disease, helps to lower protein in urine, Ferrous sulfate 325mg tablet, one tablet twice a day by mouth and Azathioprine 50mg tablet once a day by mouth. On 11Feb2021, the patient had experienced hives. The adverse event was not resulted in emergency room. Treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. Additional Context included Caller is the husband of the patient. His wife received the first dose of the vaccine on Monday 08Feb2021. She woke up today with itchy bumps around 7am this morning. She went to the dermatologist today at 1330 and the dermatologist confirmed it was hives. States nothing has changed with her aside from getting the vaccine. She has never had hives before. Treatment: She is prescribed a topical cream which has not been picked up yet, she was told take a Zyrtec Outcome: The hives are moving into different areas, some areas of the the itchiness has gone away and she is getting new bumps in different areas. HCP: declined to provide, she is going to see a different primary, she usually just sees her nephrologist Her nephrologist and rheumatologist work together in regards to her medications. She got the flu shot last year, months ago. The outcome of the event was not resolved.
28 2021-05-04 shingles Migraine to the point of a blackout; Migraine to the point of a blackout; Shingles Breakout; This is... Read more
Migraine to the point of a blackout; Migraine to the point of a blackout; Shingles Breakout; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles breakout migraine to the point of a blackout on 18Apr2021. There was no treatment received for the events. The outcome of the events was not recovered. Information about lot/batch has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the report migraine to the point of a blackout and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-05-10 vaccination site pain On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air p... Read more
On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air pressure,; Slight woozy/dizziness; Injection site soreness; tingly outside of left arm / left pinky; Very mild headache; tiredness; Stiff / sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; slight numbness/ Slight numbness in pinky fingers on both hands, and left toes; General "not feeling good"; nausea; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included developmental trauma disorder, drug allergy, allergies certain adhesives, borderline personality disorder, and irritable bowel syndrome. Patient is not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient experienced very mild headache, and mild tiredness were on 06Apr2021. On 07Apr2021 (day 2), patient was experienced injection site soreness, tingly outside of left arm/ left pinky. During day 6-7 (in Apr2021), patient experienced headache, stiff / sore neck (including upper shoulder area) left side of left arm and leg including hand and foot, tingly and slight numbness, general "not feeling good", slight nausea/ need to lie down, but not fatigue / wooziness. No fever. On 13Apr2021 (day 8), patient experienced slight woozy/dizziness, in waves. Slight numbness in pinky fingers on both hands, and left toes. On 14Apr2021 (day 9), on and off neuropathy in hands and feet, specifically left leg from knee down (outside of left toes and bottom of left foot) and pinky fingers, most notably when falling asleep/ waking up, or after being on my feet for a while. Right ear sensitivity/ "popping", like with changing air pressure, but on and off (most likely unrelated, but during same period). Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment for events. The patient underwent lab tests and procedures which included saliva test: negative on 13Apr2021. The outcomes of events were unknown.
29 2020-12-31 injection site redness, injection site swelling Fatigue, joint pain, muscle aches, stabbing headaches, redness and swelling at injection site.
29 2020-12-31 skin burning sensation Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches an... Read more
Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue
29 2021-01-01 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Site pain, nausea, fatigue, feeling unwell, headache
29 2021-01-02 injection site pain Approximately 5 hours after administration, I developed severe pleuritic chest pain and tachycardia ... Read more
Approximately 5 hours after administration, I developed severe pleuritic chest pain and tachycardia that self resolved after about an hour. This was followed by about 2 days of fatigue and myalgias that interfered with my daily activities that also self resolved. Had a large tender reaction on my left bicep for about 5 days after the injection.
29 2021-01-03 injection site mass, injection site warmth, injection site redness About 12 hours post vaccination, I developed body aches and fever and chills which persisted for ano... Read more
About 12 hours post vaccination, I developed body aches and fever and chills which persisted for another 48 hours. I had taken Tylenol 1000mg q6 hours about 14 hours after the vaccine for until Saturday. 72 hours post vaccine, body aches and chills are gone, only intermittent headaches that come and go. As of 1/3, 4th day post vaccination I have a red bump under the injection site, it is not raised but it is red and warm to touch and it still hurts while moving my left arm.
29 2021-01-03 injection site pain Elevated heart rate within the first five minutes after injection. Went away in about one minute. Ca... Read more
Elevated heart rate within the first five minutes after injection. Went away in about one minute. Came back for about one minute in five minute intervals for a duration of about 40 minutes after injection. Feeling flushed with the first 15 minutes after injection. Soreness at injection site 24-48 hours after injection.
29 2021-01-03 injection site pain developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she de... Read more
developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-01-03 hives, rash rash, hives, anaphylaxis, throat tightening, felt out of body
29 2021-01-04 rash Jan 05, 2021 : Dr.: Established Patient Video Consult :Video Consult Search Notes EditExportPrintRep... Read more
Jan 05, 2021 : Dr.: Established Patient Video Consult :Video Consult Search Notes EditExportPrintReportsFaxRx1 of 1 Age29Visit TypeEstablished Patient Video Consult DateJan 05, 2021StatusUnsignedProviderDr. Signed by-- Subjective Chief Complaints Pfizer vaccine last Tuesday on Left arm.. 1.5 days later on opposite arm around elbow. Chief Complaint Rash History of Present Illness Location of symptoms: Generalized body, Chest, Abdomen, Upper Extremities, Right, Left Timing: Worsening on prednisone and famotidine oral treatment
29 2021-01-04 injection site pain Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after in... Read more
Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after injection. Muscle soreness at injection site beginning in the evening.
29 2021-01-04 injection site pain Muscle soreness at the injection site. Significant for 2 days.
29 2021-01-04 injection site pain, skin warm, injection site pruritus, blister Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness,... Read more
Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.
29 2021-01-04 hives Woke up at 12:40 in the morning and was covered in hives and my face and ears were swollen
29 2021-01-04 vaccination site redness, vaccination site pain some redness was noted at injection site; Pain at injection site; This is a spontaneous report from ... Read more
some redness was noted at injection site; Pain at injection site; This is a spontaneous report from a contactable Physician (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot number: EL0140), intramuscular in Left arm on 24Dec2020 at 11:45 am at single dose for COVID-19 immunisation . Medical history was none.No known allergies to medications, food, or other products. There were no concomitant medications. On 24Dec2020 at 10:00 pm (as reported) the patient experienced pain at injection site and on 25Dec2020 some redness was noted at injection site; events were reported as non-serious and described as follows: pain at injection site, started 10 hours after vaccination (as reported), lasted 24 hours. Also some redness was noted at injection site a day after vaccination, that self resolved in 2 days. Patient did not need to take any pain medication, no treatment given for the events. Patient recovered from the events in Dec2020.
29 2021-01-05 injection site pain Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and ... Read more
Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.
29 2021-01-05 rash I received the first dose and one week later I formed a rash on my lower legs and a fever. The docto... Read more
I received the first dose and one week later I formed a rash on my lower legs and a fever. The doctors suspect Erythema nodosum but the tests are still pending.
29 2021-01-05 hives hives tickle in throat 1 hour post vaccination
29 2021-01-06 injection site pain Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site sorene... Read more
Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative: 12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.
29 2021-01-06 rash with redness, rash papular, skin warm I received the pfizer COVID vaccine Wednesday 12/16. I noted an erythematous raised warm painful con... Read more
I received the pfizer COVID vaccine Wednesday 12/16. I noted an erythematous raised warm painful confluent blanching rash on 12/18. So far I have not has SOB, fatigue, N/V - any other systemic sx.
29 2021-01-06 sensitive skin, pain of skin Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobi... Read more
Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
29 2021-01-06 shingles, itchy rash, rash On 1/3 I developed a rash along my right side, under my right arm pit and along right breast. This p... Read more
On 1/3 I developed a rash along my right side, under my right arm pit and along right breast. This progressed the following days, became itchy and painful. The pain was shooting. I saw my PCP office on 1/6 and was diagnosed with Shingles.
29 2021-01-06 injection site pain ~3 hours after injection: soreness at injection site After waking up the next morning: 101F fever, f... Read more
~3 hours after injection: soreness at injection site After waking up the next morning: 101F fever, fatigue, muscle soreness, headache
29 2021-01-07 hives 6 hours post vaccine patient developed a bad headache; 12 hours post vaccine patient developed a tem... Read more
6 hours post vaccine patient developed a bad headache; 12 hours post vaccine patient developed a temperature of 102 degrees tympanic; 36 hours post vaccine patient developed hives on both feet. 48 hours post vaccine patient's headache and fever were gone and mild hives remained on the feet.
29 2021-01-07 hives Anaphylactic reaction; hives in the first 10 minutes of the vaccine; This is a spontaneous report fr... Read more
Anaphylactic reaction; hives in the first 10 minutes of the vaccine; This is a spontaneous report from a contactable Other Health Professional (Physician Assistant). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she is treating a patient in ICU that got the COVID-19 vaccine on 29Dec2020. The patient developed hives in the first 10 minutes of the vaccine and had an anaphylactic reaction 1 hour later. Seriousness of events was reported to be hospitalization. Outcome of the events was unknown. The reporter also mentioned that it was not a mild reaction and patient was still in the ICU, 48 hours later. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction and hives cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-01-07 itchy skin Had Throat and chest tightness, SOB, pruritis within 5 min of covid immunization. BP: 146/111, P 14... Read more
Had Throat and chest tightness, SOB, pruritis within 5 min of covid immunization. BP: 146/111, P 144; o2 99%, RR 16. She was given albuterol inhaler x 3, Epi-pen x 1, benadryl 25 mg with some iprovement. She was sent to ED. PMHx: tree nut allergy, Hashimoto's thyroiditis, hereditary hemochromatosis, PCOS; Taken to ED
29 2021-01-07 hives Hives: starting this AM
29 2021-01-07 injection site pain I got the injection on my right arm & on my elbow area it was really painful it was like a broken ar... Read more
I got the injection on my right arm & on my elbow area it was really painful it was like a broken arm because I couldn't do anything with it. Seen doctor on 12/24/2020
29 2021-01-07 injection site pain I got the shot on the top of my right arm but on my right elbow area was really painful it was like ... Read more
I got the shot on the top of my right arm but on my right elbow area was really painful it was like a broken arm because I couldn't use it I couldn't do anything with it but it got better after 4 days. Seen doctor on 12/24/2020.
29 2021-01-07 injection site pain, injection site swelling, injection site redness Left axillary lymphedema (swollen under arm pit). Can?t sleep on that side or lay arm flat on that ... Read more
Left axillary lymphedema (swollen under arm pit). Can?t sleep on that side or lay arm flat on that side. Right side is perfectly fine. Slight left neck swelling also. Significant injection site pain with mild redness and swelling. Joint/muscle pain. These events also occurred after my first covid Pfizer but not until day 4-5 and very mild. I have not taken any medication as of yet.
29 2021-01-07 vaccination site pain Mild nausea shortly after injection; Injection site soreness beginning in the afternoon of that day,... Read more
Mild nausea shortly after injection; Injection site soreness beginning in the afternoon of that day, continuing for days; Fatigue; This is a spontaneous report from a non-contactable other HCP. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included endometriosis. There were no concomitant medications. The patient experienced Mild nausea shortly after injection. Injection site soreness beginning in the afternoon of that day, continuing for days and Fatigue on 04Jan2021 12:45. Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine. Outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
29 2021-01-07 injection site pain Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards ... Read more
Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards of glass. By day 3, swelling in left arm and lymph nodes under arm, armpit, and side of breast. Tingling in left arm down to fingertips and "dead arm" feeling.
29 2021-01-07 rash, itchy skin Patient described Rash and itching approximately 2.5 hr after she received the pfizer covid -19 vacc... Read more
Patient described Rash and itching approximately 2.5 hr after she received the pfizer covid -19 vaccine first dose. She received 1 dose of Diphenhydramine 25mg po. Few minutes later she complained difficulty sallowing and given Epinephrine 0.3mg IM and EMT was called in. She was transported to ER by EMTs
29 2021-01-07 injection site swelling Well at injection site, swollen arm around injection site, nausea, fatigue. Resolved on 01/08/2021
29 2021-01-07 injection site pain fever 99.6 for 12 hours, soreness in upper arm and injection site
29 2021-01-07 redness, injection site pain, itchy skin red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadry... Read more
red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadryl after symptoms continued. After the second dose of benadryl, s/s subsided enough for the staff member to go home.
29 2021-01-08 injection site pain Chills, dizzy, headache, injection site pain
29 2021-01-08 injection site redness, injection site warmth, injection site swelling Redness, swelling, warmth of injection site Fatigue
29 2021-01-09 injection site pain After the second dose: arm pain at the site, chills, fatigue, body aches and headache for about 20 h... Read more
After the second dose: arm pain at the site, chills, fatigue, body aches and headache for about 20 hours starting 4 hours after shot. After first dose: injection site pain the next day
29 2021-01-09 injection site pain Around 4 am. Fever of 100.2 and chills that lasted about 12 hours. Headache that was unrelieved by m... Read more
Around 4 am. Fever of 100.2 and chills that lasted about 12 hours. Headache that was unrelieved by medication that lasted 24 hours. Fatigue that lasted 24 hours. Severe injection site pain that lasted 12 hours. Nausea that lasted about 12 hours.
29 2021-01-09 injection site pain, injection site redness Diffuse Myalgias, chills, low grade fever requiring Tylenol day after vaccination. Now resolved. ... Read more
Diffuse Myalgias, chills, low grade fever requiring Tylenol day after vaccination. Now resolved. Round, erythematous, flat, tender area on arm about 2 cm inferior to injection site. First noticed 3 days after vaccination.
29 2021-01-09 injection site swelling, injection site redness Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccinatio... Read more
Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction. Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot
29 2021-01-09 itchy skin, hives Pt complaints of itching and hives. Liquid Benadryl give(25mg) Pt symptoms resolved
29 2021-01-09 injection site redness, injection site warmth, injection site swelling Red, hot, swollen arm at and around injection site lasting greater than 48 hours post vaccine admini... Read more
Red, hot, swollen arm at and around injection site lasting greater than 48 hours post vaccine administration. Bone pain, lymph node swelling, headache for 36 hours post.
29 2021-01-10 hives About 15 minutes after vaccine, hr 155, fever 102, covered in hives, sick to her stomach and a poun... Read more
About 15 minutes after vaccine, hr 155, fever 102, covered in hives, sick to her stomach and a pounding headache. Has had headache since then and been extremely fatigue.
29 2021-01-10 rash, hives Experiences rash on the face and hives on body, two days after receiving the second dose of the Pfiz... Read more
Experiences rash on the face and hives on body, two days after receiving the second dose of the Pfizer vaccine. Took diphenhydramine and applies hydrocortisone cream. Reaction resolved after one and half day
29 2021-01-10 injection site pain Fever, Body ache and injection site soreness. Took paracetamol - felt better.
29 2021-01-10 injection site redness, injection site warmth, injection site pruritus Injection site turned red, hot, and slightly itchy on 1/11/2021, one week and two days after receivi... Read more
Injection site turned red, hot, and slightly itchy on 1/11/2021, one week and two days after receiving the first dose of the vaccine.
29 2021-01-10 injection site pain Intense pain upon injection not felt with any other form of vaccine. Pain in arm continued to get wo... Read more
Intense pain upon injection not felt with any other form of vaccine. Pain in arm continued to get worse throughout the day. Unable to lift my arm very far without pain. Worse than any other injection recieved in the past. Pain throught the night-causing lack of sleep. Severe pain for about 24 hours or so then completely gone. My muscle in my arm then felt tight as if there was inflammation of some sort or an injury to the muscle. Upon lifting my arm it felt as if my arm was pulling back. No pain during this action but more of a weakness. No relief from anti inflammatory medicaiton or ice. Sensation in arm noted to be gone on 01/09/2021.
29 2021-01-10 injection site pain Intermittent headache starting one hour post and persisting through the next day. Fever, back ache, ... Read more
Intermittent headache starting one hour post and persisting through the next day. Fever, back ache, fatigue, injection site tenderness, and swollen lymph node to right neck, started morning after vaccine and resolved by second day after vaccine. Took Tylenol twice. Swollen lymph node under right arm, starting morning after vaccination; has reduced but remains present.
29 2021-01-10 injection site warmth, injection site swelling, injection site mass, injection site redness Red swollen lump that started same day of vaccine and is still there. Larger and hot to the touch. F... Read more
Red swollen lump that started same day of vaccine and is still there. Larger and hot to the touch. Fatigue and exhaustion. Body aches. Headache.
29 2021-01-10 injection site pain Soreness at injection site began a few hours after administration. By the evening I began experienci... Read more
Soreness at injection site began a few hours after administration. By the evening I began experiencing headache and an overall malaise feeling. This progressed into chills to the point of shivering and feeling feverish. Overnight I developed another headache and felt very mildly nauseous in addition to feeling fever/chills. Overnight I took 3 OTC Advil, was bundled up under multiple blankets, and got lots of rest. The next day I felt much better, only some fatigue.
29 2021-01-10 injection site pruritus, hives Started as itching at the injection site approx 35 minutes after shot which led to generalized itchi... Read more
Started as itching at the injection site approx 35 minutes after shot which led to generalized itching on left arm, chest, and back when another colleague examined my back and noted hives. Became slightly short of breath and felt my heart was racing. Took 25 mg of oral Benadryl and told to go to ED. In ED heart rate was 126 bpm and BP WAS 136/99. Monitored in the ED for a few hours with no further interventions. Heart rate improved to 102 bpm and blood pressure to 129/82.
29 2021-01-10 sensitive skin Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse th... Read more
Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse throughout the day. Temperature at 10:00 pm (14 hrs after injection) was 99.1 degrees Fahrenheit. Went to bed and woke up the next day feeling better. Slight sensitive skin, sore neck, and headache. Did not urinate for 9 hours.
29 2021-01-11 injection site pain During the first few hours following vaccination, I had soreness at the injection sight and a mild h... Read more
During the first few hours following vaccination, I had soreness at the injection sight and a mild headache. About 10hours later, I started to experience more severe symptoms including a fever of 101-102deg, chills/cold sweats, a moderate headache, and body aches. This continued throughout the night and into the next day. In addition, I began to experience a burning sensation in my chest, similar to heart burn. I have consistently been taking Tylenol and recently took Tums to aide with the heartburn feeling.
29 2021-01-11 injection site pain Headache-Tylenol /onset 10 hours after Pain at injection site-onset 10 hours after Fatigue-onset 10... Read more
Headache-Tylenol /onset 10 hours after Pain at injection site-onset 10 hours after Fatigue-onset 10 hours after Left side Lymph node pain-onset morning after Joint pain-onset 10 hours after Body aches-onset 10 hours after
29 2021-01-11 injection site pain Nausea Body aches Fatigue Headache Injection site soreness
29 2021-01-11 rash macular Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began ... Read more
Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began to start breathing rapidly and become short of breath. Also, red blotches started to develop around her neck. Epi 0.3 mg IM given along with diphenhydramine 50 mg orally.
29 2021-01-11 vaccination site pain, vaccination site redness have pain in my left arm where it was administered the vaccine/the area was red and inflamed; have p... Read more
have pain in my left arm where it was administered the vaccine/the area was red and inflamed; have pain in my left arm where it was administered the vaccine/the area was red and inflamed; pain in my left arm where it was administered the vaccine; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient experienced started to have pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00. The next day (16Dec2020) the area was red and inflamed. The redness and the inflammation lasted three days. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events 'redness and the inflammation' was recovered on 19Dec2020, outcome of the other event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
29 2021-01-12 injection site pain 11 hours after administration, I experienced chills without objective fever, myalgias, localized inj... Read more
11 hours after administration, I experienced chills without objective fever, myalgias, localized injection site muscle soreness, headache.
29 2021-01-12 injection site pain After first dose: moderate right deltoid soreness only After second dose: fever, chills, nausea for ... Read more
After first dose: moderate right deltoid soreness only After second dose: fever, chills, nausea for about 36 hours from onset time listed, significant headache and fatigue for 48 hours from onset time listed
29 2021-01-12 vaccination site pain I am having chills since last night; Shortness and breathlessness last night; throat is super dry; d... Read more
I am having chills since last night; Shortness and breathlessness last night; throat is super dry; don't have too much pain in my left arm right where I got the vaccine; Left clavicle that is swollen and painful to touch; Left clavicle that is swollen and painful to touch; Little bit fever; This is a spontaneous report from a contactable consumer reported for herself. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiry date: Apr2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose to get vaccinated to prevent COVID. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and hadn't taken Vitamins yesterday or day before. The patient got yesterday on 05Jan2021 the vaccine and thought that it was a side effect which she didn't have with the first vaccine. She had been having chills since last night 05Jan2021 and little bit of fever in Jan2021. She didn't have too much pain in her left arm right where she got the vaccine but her left clavicle that was swollen and painful to touch in Jan2021. The patient felt like she had a little bit of shortness and breathlessness last night 05Jan2021 but she was fine, her throat was super dry in Jan2021. For lot number, she stated "It is E. I am not sure what the next one is. It might be like a 21284." The patient had taken only pain killers she took two pain killers before she went to bed she took two pain killers when she woke in the middle of night and in morning. For Lab work, she just started feeling like between 12. The outcome of the events was unknown. Information on the lot/batch number has been requested.
29 2021-01-12 rash I got a rash, I felt like it started on my legs and spread everywhere. It spared my face, neck and b... Read more
I got a rash, I felt like it started on my legs and spread everywhere. It spared my face, neck and back. I went to the Doctor . The Dr gave me a steroid shot and some cream to help with the itch. The rash went away about two days later.
29 2021-01-12 rash On 1/6/2021, Felt like she got hit by a train. Fever 102. Body aches from head to toe. Dizziness ... Read more
On 1/6/2021, Felt like she got hit by a train. Fever 102. Body aches from head to toe. Dizziness with intermittent slight rash. On 1/7/2021 she developed severe muscle pain, joint pain, fever, and intermittent lightheadedness and dizziness. She went to the emergency room on 1/10/2021 but no changes made in medications. She reports her BP was 207/111 and her pulse was 165/minute and still runs that high now. She had hypertension and tachycardia. About 1.5 years ago she had a history of hypertension and tachycardia. 1/12/2021 this person continued to have hypertension and tachycardia. Instructed to make an appointment to see her primary physician.
29 2021-01-12 rash This person stated she felt like she was hit by a train starting about 8pm on 1/6/2021. She stated ... Read more
This person stated she felt like she was hit by a train starting about 8pm on 1/6/2021. She stated she had a fever of 102. Her body ached all over from head to toe. She had dizziness with an intermittant rash. She did go to the emergency room on Sunday 1/10/2021 with hypertension and tachycardia. Her BP was running at around 207/111 and her pulse has stayed around 165 even through today on 1/12/2021. She did state about 1.5 years ago she experienced tachycardia and hypertension but not since. She did not get any new medications upon her visit to the emergency room. She was going to try to see her physician today if possible on 1/12/2021.
29 2021-01-12 injection site pain Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn,... Read more
Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness
29 2021-01-12 vaccination site pain fever of 38C; severe fatigue and malaise; severe fatigue and malaise; mild headache; Pain in the inj... Read more
fever of 38C; severe fatigue and malaise; severe fatigue and malaise; mild headache; Pain in the injection site began within a few minutes and gradually increased reaching it's maximum around 8 hours after the dose.; Neck pain was also significant; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 12:00 PM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 09:00 PM (Arm Right) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included asthma and generalized anxiety disorder (GAD). The concomitant drug was reported as Escitalopram. The patient experienced pain in the injection site began within a few minutes (05Jan2021 12:15 PM) and gradually increased reaching it's maximum around 8 hours after the dose. Neck pain was also significant (05Jan2021 12:15 PM). Fatigue, malaise and mild headache started around 10 hours (05Jan2021 22:00) following vaccine administration. Almost 24 hours following administration (06Jan2021 12:00) a fever of 38 C started and persisted for about 6-8 hours. It subsided but severe fatigue and malaise (that prevent me to do daily activities) are still persisting greater than 48 hours following administration. The outcome of severe fatigue and malaise was not recovered. The outcome of Headache, Pain in the injection site, Neck pain, fever of 38 C, was recovering. No treatment received for the adverse event. No COVID prior vaccination and no COVID tested post vaccination. Information on Lot/batch number has been requested.
29 2021-01-13 sensitive skin, injection site pain 1 hour after: local site pain, ache throughout same extremity 24 hours after: chills and overall ski... Read more
1 hour after: local site pain, ache throughout same extremity 24 hours after: chills and overall skin sensitivity 48 hours: respiratory symptoms- cough, sore throat, runny nose, congestion
29 2021-01-13 rash macular, rash, rash with redness 1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken... Read more
1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken: bp-155/97, P-77, O2@98%, R-16. Reported to pharmacist who adm. vaccine, staff member was given water and told to stick around an additional 15 min for monitoring. 1257: Pharmacist rechecks staff member and notices Blotchy redness to her neck and chest, does not report signs of itchiness but does feel warm, window opened nearby, cont. to monitor staff member, 1320: staff member reports she feels better. 1309: staff member rechecked by pharmacist,
29 2021-01-13 injection site pain, injection site warmth, injection site redness I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I star... Read more
I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I started feeling a little tired and some pain around the injection site. I had anticipated this as I felt similar symptoms from the first dose of the vaccine. I took a nap and woke up around 09:00pm feeling some of the worst body aches I had felt in a long time. My arm that I received my vaccine in was painful and warm to the touch. I felt dehydrated as well so I drank a pedialyte, took OTC Tylenol extra strength, and laid down again. Around 07:00am on 1/13/21, I still felt achy, sweaty, and felt pain in the arm that I recieved the vaccine in. I went into my bathroom, and noticed two small red and raised areas around the injection site. I took pictures of the site, and continued to closely monitor through out the day. I ended up calling in sick to work on 1/13/21. It is now around 12:00pm on 1/14/21, and I woke up with a pounding headache, muscle aches, dehydration, nausea, and low energy. I feel like I am hungover or have the flu, and am planning on calling in sick to work again. I reported my symptoms to my staffing department at my workplace on 1/13/21 and wanted to file a report here as well.
29 2021-01-13 injection site pain Left axillary lymphadenopathy and deltoid muscle soreness
29 2021-01-13 redness Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, ... Read more
Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, and fatigue for about 30 hours. Post 3 days after injection all finger tips have been cold, red, numbness, and tingling. Now post 5 days after injection finger tips have improved but still red, cold and difficult to get warm.
29 2021-01-13 injection site redness, injection site warmth On 1/14/2021 at 0630am, I noticed my armpits were bright red, with no raised rash, and warm to the t... Read more
On 1/14/2021 at 0630am, I noticed my armpits were bright red, with no raised rash, and warm to the touch. There is a sensation of warmth and feeling "full" in this area. At this time, no treatment has been taken as it is not uncomfortable. It is 1:45pm, and all symptoms are still present. The warmth sensation has slightly increased throughout the day. I have had bouts of chills throughout the day, but no fever or headache.
29 2021-01-13 rash papular, itchy skin, redness, rash Patient received first dose of Pfizer COVID-19 vaccination last evening. This morning, she awoke and... Read more
Patient received first dose of Pfizer COVID-19 vaccination last evening. This morning, she awoke and went to the bathroom at approx 0700 and noticed the red, raised rash throughout her lower extremities. She further noticed the same pattern distributed throughout her entire body including scalp. She endorses only very mild to no pruritis and denies associated pain. She does endorse mild chills and malaise noticed last PM following the shot. In addition, at her office visit this morning, she had a low grade fever of 100.2 measured. She given ibuprofen in clinic, as well as recommended ibuprofen, acetaminophen and prescribed famotidine, loratadine, and diphenhydramine for her symptoms and instructed to follow back up at the clinic tomorrow. Photos were taken of the rash and sent by patient to appropriate contact.
29 2021-01-13 injection site pain Person giving the injection gave it in the back of my arm, almost as if she was giving a sq injectio... Read more
Person giving the injection gave it in the back of my arm, almost as if she was giving a sq injection. They used the 1in needle so I think she got into my tricep but it was nowhere near my deltoid. I have injection site soreness which is why I think she even got to the muscle but I have none of the classic immune reaction symptoms. I wanted it on record in case it was not thoroughly absorbed and then I wouldn't be covered. I figured with this being so new every mistake matters. I'm going to try and get an antigen test in 2-3 weeks.
29 2021-01-13 rash THE PATIENT RECEIVED HER 1ST DOSE OF THE COVID-19 VACCINE AND WAS OBSERVED BY MATHER STAFF FOR THE R... Read more
THE PATIENT RECEIVED HER 1ST DOSE OF THE COVID-19 VACCINE AND WAS OBSERVED BY MATHER STAFF FOR THE REQUIRED 15 MINUTES WITHOUT INCIDENT. SHORTLY AFTER LEAVING THE VACCINATION POD THE PATIENT BELIEVED TO BE HAVING A REACTION TO THE VACCINE AND PRESENTED AT MATHER EMERGENCY DEPARTMENT FOR EVALUATION. A SCATTERED RASH TO HER RIGHT FOREARM, RIGHT FACE & CHEST WERE NOTED BY THE CARE PROVIDERS. THE PATIENT RECEIVED BENADRYL 50MG BY MOUTH X 1, WHICH EFFECTIVELY RESOLVED THE SIGNS & SYMPTOMS.
29 2021-01-14 itchy skin Covid vaccine on 1/11/2021. Tested positive for covid 1/13/2021. Developed lip swelling, hand/feet s... Read more
Covid vaccine on 1/11/2021. Tested positive for covid 1/13/2021. Developed lip swelling, hand/feet swelling and itching on 1/14/2021. Improved with benadryl.
29 2021-01-14 itchy rash, rash Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on ... Read more
Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on nose (itchy and burning). Jan14- extreme fatigue, nausea, loss of appetite, rash continues but no itching, light on burning, body aches, cold, could not get warm, temp stayed around 96.0-97.0 Jan 15- fatigue, nausea, extreme congestion, sweats, symptoms of a fever over night and during day. Cold sweats, shakes, cold then hot, body aches, fatigue. These happened off and on through the day. When started feeling crappy took temp and it was 99.6-99.8. When feeling cold temper drops down to 97.0 scratchy voice voice congestion, runny nose, little sore throat, when swallowing pills or hard texture foods, sometimes drinking something. Overall feeling of a cold. I think it?s important to note that I had Covid-19 in the month of November and received my first vaccine December 22nd. I had side effects after the first shot but not nearly as bad as this time. I am nurse in a doctors office if that matters at all. I am still feeling under the weather but wanted to get these down before I forgot them.
29 2021-01-14 itchy skin Pt received dose second Pfizer COVID vaccine. Reported pruritus all over her body - patient was noti... Read more
Pt received dose second Pfizer COVID vaccine. Reported pruritus all over her body - patient was noticeably scratching herself. Patient was given 12.5 mg benadryl and was observed for an additional 15 minutes. Patient reported still having pruritis and was given an additional 12.5 mg benadryl, and was observed again for an additional 15 minutes. At the end of the 15 minutes she reported feeling much better and was sent home.
29 2021-01-14 injection site pain, injection site bruising The area where I received the injection was very sore for approximately 4 days. A week after my firs... Read more
The area where I received the injection was very sore for approximately 4 days. A week after my first dose, the lymph node in my left armpit became painful and swollen. Also, the injection site has a 2? round, bruise that appeared a week following the injection.
29 2021-01-14 vaccination site pain whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain wi... Read more
whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.
29 2021-01-16 skin warm, injection site pain Around 2 AM on 1/15/21 (about exactly 12 hours after receiving the 2nd COVID vaccine injection) I wo... Read more
Around 2 AM on 1/15/21 (about exactly 12 hours after receiving the 2nd COVID vaccine injection) I woke up with severe chills and had a fever of 102 degrees F. Also had joint pain in knees/ankles and thigh muscle pain, as well as injection site pain. Around 9 am, fever had increased to 104.4 degrees F. After taking 1000 mg of Tylenol, fever decreased to between 100 and 101 degrees F. Around 3 pm, fever was still above 100 degrees F so took 400 mg of ibuprofen. By 5 pm, fever was finally below 100 degrees F. By 1/16/21, all side effects had resolved except lymph node in injection arm was significantly swollen, hot, and tender. By 1/17/21, side effects still resolved besides swollen and tender lymph node.
29 2021-01-17 vaccination site pain Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness a... Read more
Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.
29 2021-01-17 hives, itchy skin I experienced throat swelling itching and hives as a result of my covid vaccine. The vaccine was giv... Read more
I experienced throat swelling itching and hives as a result of my covid vaccine. The vaccine was given 1/6, symptoms occurred 1/7 overnight.
29 2021-01-17 rash I was asleep I woke up coughing. Feeling like I swallowed my necklace( it felt like there was a stri... Read more
I was asleep I woke up coughing. Feeling like I swallowed my necklace( it felt like there was a string in my throat) and labored breathing. Rash developed all over body that is similar to the rash Kawasaki syndrome kids get. Was taken to emergency room where I was given iv steroids and epi. 10-15 mins after my breathing was back to baseline and throat felt better. I have never had any trouble breathing or any allergic reactions to anything in the past.
29 2021-01-17 itchy rash, hives, rash maculo-papular Rash was pruritic and diffuse/one day later became less itchy and more macular papular in nature; De... Read more
Rash was pruritic and diffuse/one day later became less itchy and more macular papular in nature; Developed urticarial rash; Rash was pruritic and diffuse, spread to extremities, back, trunk and face; This is a spontaneous report from a contactable physician (patient). A 29-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9898; expiration date: unknown), intramuscular left arm on 21Dec2020 16:00 at a single dose for covid-19 vaccination. Medical history included depression and anxiety. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) and escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital on 21Dec2020 04:00 PM. The patient developed urticarial rash about 2 weeks (05Jan2021 07:00 AM) after receiving vaccine. The rash was pruritic and diffuse that spread to extremities, back, trunk and face. About one day later (06Jan2021), it became less itchy and more macular papular in nature. No other symptoms. No airway swelling. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment for the adverse events. The outcome of the events was recovered in Jan2021.
29 2021-01-17 rash, rash with redness Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose... Read more
Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose, got the scar in the nose, …she was bleeding from that scar; hit her nose, got the scar in the nose, …she was bleeding from that scar; She started to feel unwell; Chills; Nausea; Rash in her arm; She had little red in her bumps; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on arm on unspecified date at a single dose (2nd dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician stated, "she had no medical conditions, she was in very good you know very like standing with herself." Patient had her 1st dose of Covid vaccine on unspecified date for COVID-19 immunization. Physician (reporter) stated, "I am the parent of someone who got the COVID dose, the second dose yesterday. I am very concerned because my daughter yesterday (08Jan2021) started to have symptoms and fainted at 4:00 in the morning and hit her nose and has a scar now. She had her second dose yesterday (pending clarification), after the second dose last night she started to feel unwell, getting chills, nausea and when she got up to go to the bathroom, she fainted, she blacked out. She lives alone, she is an adult, she hit her nose, got the scar in the nose, and the bleeding wouldn't stop, she was bleeding from that scar. She told me it took two hours for bleeding to stop from that scar." When asked when the events started, Physician stated, "Last night (08Jan2021), at 4:00 am she took the shot during the day while she was at work. She said, she started to getting chills and then she was nauseated." When asked if patient was still experiencing the event, the parent reported no as patient was just resting. Also stated, "She didn't take any treatment but she said she took Tylenol." Physician further added, "I am concerned, we are going to be taking her to the urgent care now but I am concerned about what is going on with platelets and all of that because of what had happened, last night the bleeding wouldn't stop for two hours and she was alone at the night and weekends. She said, she had to lay down and then her dad is there now because he is closer, he is going to be taking care of the urgent care but I want Pfizer to know what my daughter has gone through last night after she took this second dose." Physician further added, "she is having a rash in her arm, she had little red in her bumps as well. I want her to go get checked up as soon as possible in urgent care." Patient was taking some Ibuprofen (later clarified that patient took Tylenol as treatment). She was not taking any other medication. Outcome of the events was unknown. Information Requested on Lot/ Batch number.; Sender's Comments: The reported faint was most likely due to an accident, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-01-17 injection site pain a low grade fever; cough; doesn't feel very well; feeling yucky; soreness in the arm where vaccine w... Read more
a low grade fever; cough; doesn't feel very well; feeling yucky; soreness in the arm where vaccine was given; This is a spontaneous report from a contactable Nurse (reporting for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, bacth/lot no: EK9231 while expiry date was unknown), intramuscular on left deltoid on 07Jan2021 16:45 at a single dose for covid-19 immunization. There were no medical history and concomitant medications reported. Patient has no prior vaccination within 4 weeks.The patient got her first dose of the COVID 19 vaccine yesterday (07Jan2021) from her employer. She started "feeling yucky" today (08Jan2021) around noon with a low grade fever,and developed a cough that was not persistent. Patient has soreness in the arm where vaccine was given. She was asking what should she do about it? Outcome of the events low grade fever, cough, feeling unwell, feeling abnormal were not recovered while vaccination site pain was unknown. The events low grade fever, cough, feeling unwell were considered serious medically significant and related to vaccine.; Sender's Comments: Based on the time association, the events fever, cough and malaise are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-01-17 itchy skin, hives patchy hives, itchy, turned into head to toe hives with swelling. Treated with 50mg Benadryl injecti... Read more
patchy hives, itchy, turned into head to toe hives with swelling. Treated with 50mg Benadryl injection and solumedrol injection. 4 hours later upon waking up symptoms had resolved. given prednisone pack to treat as well and oral benadryl prn for itching.
29 2021-01-18 skin warm 0931 Client felt hot at back of neck; States she has a hx of panic attacks for which she takes Ativa... Read more
0931 Client felt hot at back of neck; States she has a hx of panic attacks for which she takes Ativan PRN; States this feels the same; BP 140/95 P90 R 15; SpO2 99%; Resp unlabored; Lungs clear - no wheeze or stridor; Skin warm pink and clammy; LOC A&O x 3 0932 EMS notified; ice pack provided for back of neck for comfort 0935 P 75 SpO2 99% ; Client states she is feeling a little better 0940 BP 118/86 P 84 R 12 SpO2 99%; Resps continue unlabored; LOC A&O x 3; juice provided 0945 EMS arrived; BP 138/96 P 90 SpO2 99%; Client is feeling nervous again b/c EMS is on scene; Hand off report given to EMS. 0951 EMS retrieved Ativan from client's vehicle and allowed client to take usual dose; client feeling better; EMS departed without the client 1000 Client states feeling well enough to leave; Resps unlabored; A&O x 3
29 2021-01-18 injection site pain AE's : Injection tenderness, fever, chills, headache, malaise, severe myalgia, lymphadenopathy, mild... Read more
AE's : Injection tenderness, fever, chills, headache, malaise, severe myalgia, lymphadenopathy, mild sore throat, occasional nausea and lightheadedness when standing for longer than 5-10 minutes at a time. Tx: none Outcome: All AE's except injection tenderness and right axial lymphadenopathy fully resolved within 48 hours.
29 2021-01-18 injection site pain Approximately 12/13 hours post-vaccine dose #2 I was woken from my sleep with severe body aches. Ext... Read more
Approximately 12/13 hours post-vaccine dose #2 I was woken from my sleep with severe body aches. Extremely uncomfortable, from neck to back to calves, without improvement with Tylenol or ibuprofen, causing me to be unable to sleep. Around hour 20 post-vaccine, I started to get chills. It wasn?t just feeling cold or shivering, it was full body convulsions that lasted approximately 15 minutes. I became nauseas and dizzy after that for about an hour, unable to stand or walk anywhere. The severe body aches continued, with no improvement from Tylenol or ibuprofen or heating pad. Aches resolved around hour 30 post-vaccine and the only symptom left was pain at the injection site.
29 2021-01-18 rash papular, hives On January 15, I developed urticaria to my face and neck, with a faint papular rash on my forearms a... Read more
On January 15, I developed urticaria to my face and neck, with a faint papular rash on my forearms also. On Jan 16, I developed facial edema with continued rash which worsened throughout the day despite Benadryl. On Jan 17, the rash was improving, but the facial and neck edema had worsened to the extent that my eyes were nearly fully closed. I presented to the ED and received treatment for allergic reaction, including Epinephrine, steroids, and histamine blockers. I have no known allergies.
29 2021-01-18 injection site swelling, injection site inflammation Swelling at injection site; inflammation around injection site; This is a spontaneous report from a ... Read more
Swelling at injection site; inflammation around injection site; This is a spontaneous report from a contactable physician, the patient. This 29 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via intramuscular route of administration in the left arm on 23Dec2020 at 02:15 PM (at the age of 29 years-old) for COVID-19 vaccination. It was unknown if the patient was pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. There was no relevant medical history reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) dose 2, single dose via intramuscular route of administration in the left arm on 08Jan2021 at 11:00 AM and experienced headache, nausea, pain at the injection site, fever/chills, bodyache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste and inappropriate schedule of vaccine. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient experienced swelling at injection site and inflammation around injection site. The events were reported as non-serious. The patient was not treated for swelling at injection site and inflammation around injection site. The clinical outcome of swelling at injection site and inflammation around injection site was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information of lot/batch number has been requested.
29 2021-01-18 injection site pain Vaccine administered too high in right arm by CP. At time of administration pt felt severe burning ... Read more
Vaccine administered too high in right arm by CP. At time of administration pt felt severe burning and pain at and around right shoulder joint. After vaccine administered there was hardly any R upper arm muscle pain noted. All pain was located in the right shoulder joint 9/10. Pt unable to move or use R arm/shoulder for approximately 3 days post injection. Heat applied several times a day, arm/shoulder rested and ibuprofen 800mg taken every 6 hours. Small range of motion exercises attempted to help alleviate stiffening. Approximately 4 days post injection- very small range of motion returned 25% of baseline- still unable to use right shoulder to complete daily tasks, pain 7/10 in right shoulder joint. Pt continued to use heat, rest and ibuprofen 800mg. No muscle pain noted in right upper arm. As of 1/19/20- range of motion about 50% in right shoulder, pt has clicking and popping in right shoulder joint with all movement. Pain 5/10 in right shoulder joint with movement. Pt unable to lift object more than approximately 3lbs. Ibuprofen 800mg still taken PRN pain, heat still applied PRN. All symptoms reported in Vsafe app following injection. 1/19/21 Notified hospital through COVID question hotline- RN charted problem in pts medical record. Pt concerned because there is not a significant improvement 10 days post injection. Also due to the lack of information about adverse events of the Pfizer COIVD 19 vaccine.
29 2021-01-20 itchy skin 5 minutes after receiving the second Pfizer COVID19 vaccine, it reportedly felt difficult to swallow... Read more
5 minutes after receiving the second Pfizer COVID19 vaccine, it reportedly felt difficult to swallow, tongue felt large. Epi Pen administered and IM Benadryl. She was then transported to ER. On route, felt throat irritation, sore and a little bit of itchiness all over but no hives. She was observed in ER x 4 hours and released.
29 2021-01-20 vaccination site redness, vaccination site warmth, vaccination site pain Approx. 2x2: painful, red, warm, raised area at injection site; Approx. 2x2: painful, red, warm, rai... Read more
Approx. 2x2: painful, red, warm, raised area at injection site; Approx. 2x2: painful, red, warm, raised area at injection site; Approx. 2x2: painful, red, warm, raised area at injection site; This is a spontaneous report from a contactable nurse (patient herself). A 29-year-old female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose on 18Dec2020 (lot number: EK5730) and second dose on 08Jan2021 (lot number: EK9231), both intramuscular in the left arm (injection placed approximately 8" below acromion process, medial side of arm, not into deltoid) at single dose for COVID-19 immunization. Medical history included asthma and covid (reported as "if covid prior vaccination: Yes"). The patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), sertraline hydrochloride (ZOLOFT), and melatonin. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL), and both experienced with known allergies. The patient had not tested for COVID post vaccination. The patient experienced approx. 2x2: painful, red, warm, raised area at injection site on 09Jan2021 04:00. No treatment received for these events. The outcome of the events was recovering.
29 2021-01-20 rash with redness, rash papular, rash Red, slightly raised rash covering back and both arms.
29 2021-01-21 rash Anaphylaxis. Upper Extremity Rash, and Shortness of breath with throat swelling.
29 2021-01-21 rash with redness, hives, rash, injection site warmth, injection site pain Began about 1.5-2 hrs after vaccine Hives, red rash all over face and body. Fever of 103 disoriente... Read more
Began about 1.5-2 hrs after vaccine Hives, red rash all over face and body. Fever of 103 disoriented trouble breathing and speaking and remembering. Dizzy. Alternating high and low blood pressure. Chills. Body aches. Sore tenderness and warmth at injection site. Sluggish speach
29 2021-01-21 injection site pain Headache, fatigue, soreness at injection site, mild nausea
29 2021-01-21 hives Hives presenting on the face that improves slightly with taking PO Benadryl. Hives still present aft... Read more
Hives presenting on the face that improves slightly with taking PO Benadryl. Hives still present after two days from initial presentation. Continued use of Benadryl is needed.
29 2021-01-21 injection site pain Pain on area of injection so bad I can?t move or use my right arm. Started around 7:30pm the day of ... Read more
Pain on area of injection so bad I can?t move or use my right arm. Started around 7:30pm the day of the vaccination. Day after vaccination I have fever, nause, joint pain, chills, and the pain in the arm persists.
29 2021-01-21 rash Rash on upper chest, neck, and face. Tried Benadryl with gradual improvement.
29 2021-01-22 injection site rash, rash, injection site nodule Pfizer-BioNT Tech COVID-19 Vaccine EUA. Rash of bumps on the left arm where injection occurred as we... Read more
Pfizer-BioNT Tech COVID-19 Vaccine EUA. Rash of bumps on the left arm where injection occurred as well as a rash on right side of neck some difficulty breathing. Albuterol and Benadryl were taken to address the reaction.
29 2021-01-23 sensitive skin Headache, body ache, abdominal/stomach cramps, chills, fever, sensitive skin
29 2021-01-24 hives Hives; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-... Read more
Hives; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142; Expiration date was not reported) on 30Dec2020 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included asthma, gastroesophageal reflux disease (GERD) and allergy to sulfa drugs. Concomitant medication included omeprazole. On 06Jan2021 (20:00), the patient had hives. The hives was further reported to have occurred in two instances: first was 14 days after receiving the vaccine, and the second was 17 days after vaccination (pending clarification on event onset date). The patient did not receive any treatment for the reported event. The outcome of the event, hives, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and was not tested post-vaccination.
29 2021-01-24 hives Less than 24 hours after the vaccine, I had hives all over my body. Face, neck, stomach, back and le... Read more
Less than 24 hours after the vaccine, I had hives all over my body. Face, neck, stomach, back and legs. They have lasted for 48 hours and have not gone away.
29 2021-01-24 injection site pain Residual moderate pain and tenderness at deltoid site with tingling and radiation down to left arm. ... Read more
Residual moderate pain and tenderness at deltoid site with tingling and radiation down to left arm. 3 weeks post injection.
29 2021-01-24 injection site pain Severe injection site pain that began around 2 hours and went into the evening, severe in the evenin... Read more
Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.
29 2021-01-25 injection site pruritus, injection site swelling, injection site pain, injection site redness 7 days after the 1st dose of the covid Pfizer vaccine, I developed symptoms at the injection site on... Read more
7 days after the 1st dose of the covid Pfizer vaccine, I developed symptoms at the injection site on my left arm that included mild tenderness, moderate itchiness, severe swelling, and severe erythema. At the start the swelling was approximately 6.5cmx 7cm. We drew a circle around the swelling and by the end of my shift (12 hours later) the swelling and redness at exceeded the original circle we drew. I had no other symptoms systemically, only at the injection site.
29 2021-01-25 sensitive skin Fatigue; Sensitive skin; Chills; Body aches; This is a spontaneous report from a non-contactable oth... Read more
Fatigue; Sensitive skin; Chills; Body aches; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176), intramuscular in the left arm on 11Jan2021 12:30 at a single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730), intramuscular in the left arm on 12Dec2020 11:30 at the age of 28 years old for COVID-19 immunization. The patient had not been tested for COVID-19 since the vaccination. On 11Jan2021 20:00, the patient experienced fatigue, body aches, sensitive skin, and chills. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.
29 2021-01-25 rash with redness, itchy skin, hives On the day of the shot, hives?broke out in hives in the evening after a hot shower. Every day I have... Read more
On the day of the shot, hives?broke out in hives in the evening after a hot shower. Every day I have had itchy skin, almost like the feeling of dry skin, but with a red rash on face, chest, arms, and legs.
29 2021-01-25 hives Started breaking out in hives; This is a spontaneous report from a contactable consumer (patient). A... Read more
Started breaking out in hives; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received the first dose of BNT162B2, lot number: EL0142, via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history included asthma (had an Inhaler just for whenever it's bad but she hadn't taken it in probably over a year), had typhoid once in the past as a child and had an allergy to Sulfa drugs (Unspecified Medication). The patient's concomitant medications were not reported. Patient stated she got the Vaccine on 30Dec2020 and a week later that would have been on 06Jan2021, she believed that was the date that evening she started breaking out in hives and she typically had typhoid once in the past as a child because she had an allergy to Sulfa drugs (Unspecified Medication). So she got hives a week later and she got them again three days later both in the evening and both disappeared by the time. She woke up in the morning she didn't take any antihistamines or anything. The patient wanted to know if that was a reaction other people were having and could provide any advice on second dose. She was supposed to get the second dose on the 21Jan2021. Patient stated it was twice that she had received the vaccine, she broke out with hives and it was not typically normal for her. The patient had lab testing a couple of weeks prior to the report, just took a whole blood drawn to check some of her levels. No treatment was received for the event. The outcome of the event was recovered in Jan2021.
29 2021-01-26 hives, redness, rash, skin peeling, itchy skin 1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heig... Read more
1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heightens, slight chills, more fatigue 7pm ear itch both sides, all ear involved even lobe and red 9pm soreness, chills, arm pain 1/15 Friday 7:30am nausea, dizziness, sinus pressure, headache, arm pain 1pm extreme fatigue, sleep for afternoon, arm pain 4pm headache intensify, arm pain 6pm both ear swelling, warmth, extreme itch 9pm lingering headache, arm pain improves 1/16 Saturday 7am ear itch and rash spread to back of neck 12pm telehealth - recommended benadryl, Rx prednisone Benadryl ineffective, rash remains 8pm- itch inside ears, red scaly ears, hot after washing, extremely scaly 1/17 Sunday 6 pills of methyl prednisone Hives moved to back of neck following the back of ear 1/18 Monday 6pills prednisone inside ear itch, ear lobes itch, skin very flaky 1/19 Tuesday Go to urgent care 6pills prednisone 1/21 Thursday Rash spreads to collarbone Go to TMC Dermatology prednisone continued 1/24 Sunday Stopped steroid under recommendation of MD Huge flare up around neck, chest, back and down to lower body Itch continues to night, lack of sleep 1/27 Wednesday Placed back on steroid (16 day course) Rash remains, itch subsided Decision to not take second dose
29 2021-01-26 redness, hives 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressu... Read more
1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
29 2021-01-26 injection site pain Sore injection site at 10:00pm day of injection. Morning of day after chills, fever, sore throat, co... Read more
Sore injection site at 10:00pm day of injection. Morning of day after chills, fever, sore throat, cough, short of breath. 48 hours later same symptoms but fever is worse. I?ve been alternating Tylenol and Advil Q 4 hours. Had a COVID test performed on 1/26/2021. Negative results morning of 1/27/2021. Currently extremely sore throat, cough, fever, short of breath.
29 2021-01-26 rash, itchy skin Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Headache-... Read more
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Headache-Severe, Systemic: Other- Itching-Severe
29 2021-01-27 hives, injection site hives, itchy skin 1 hour after vaccine received, patient experienced itching, initially she felt it could have been re... Read more
1 hour after vaccine received, patient experienced itching, initially she felt it could have been related to something else, however after going home and showering, itching persisted and involved the entire body. Injection site developed bumps that looked like hives per report and spread the entire arm. The patient took a dose of diphenhdyramine however itching and hives continued into the night and could not sleep, another diphenhdyramine dose was taken and she was able to sleep for a few hours. She went to see her PCP who deemed this an allergic reaction to the vaccine, gave her oral steroid along w topical cream. The bumps and hives subsides within 24 hours of steroid use, and the itching resolved after 2 days of initiating steroid (3 days post vaccine) . Steroids were started 1 day post vaccine. PCP recommended patient sees an allergist for further investigation and refrain from second dose of vaccine
29 2021-01-27 injection site redness, injection site pruritus, injection site warmth Delayed redness/warm to touch around injection site worsening on Day 8 post vaccine with itchiness. ... Read more
Delayed redness/warm to touch around injection site worsening on Day 8 post vaccine with itchiness. 2.25 inches by 2 inches in size
29 2021-01-27 redness Sudden redness over chest, neck, and face. Heart rate at rest jumping from 73 to 165 bpm, sweating, ... Read more
Sudden redness over chest, neck, and face. Heart rate at rest jumping from 73 to 165 bpm, sweating, dizziness, feeling on verge of passing our. Heart rate and symptoms subsided at 15 min. Dizziness continued for next hour with fluctuations in heart rate and Blood pressure taken at 110/88.
29 2021-01-28 pain of skin Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature w... Read more
Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature was 103.5F when I checked it at 12:30am. I removed clothing and put ice on my neck, and took tylenol and the fever came down to 102.5F in 30 min. I had a moderate headache, felt lightheaded and a little disoriented, and nauseous. The following morning and the entire next day I had a moderate to severe headache, malaise, nausea, and a low grade temp 99-99.8F.
29 2021-01-28 hives Hives developed on the injection arm and spread across her chest; intense heart palpitations; weakne... Read more
Hives developed on the injection arm and spread across her chest; intense heart palpitations; weakness/dizziness; weakness/dizziness; This is a spontaneous report from a contactable Nurse (patient). A 29-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 07Jan2021 13:00 at SINGLE DOSE for COVID 19 vaccination. The patient was not pregnant. Medical history included Shellfish allergy. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 on 17Dec2020 07:00 AM at left arm for COVID 19 vaccination. On 07Jan2021, hives developed on the injection arm and spread across her chest within 5 minutes of receiving the vaccine, along with intense heart palpitations and weakness/dizziness. Resolved spontaneously after 10 minutes without any use of epinephrine or other medications. Oral diphenhydramine was taken afterwards. Treatment drug oral diphenhydramine received for events. The outcome of the events was recovered in Jan2021. No covid prior vaccination, no covid test post vaccination. Information on the lot/batch number has been requested.
29 2021-01-28 itchy skin Itchy eyes/ears - 2 Benadryl were given (50mg).
29 2021-01-28 rash, skin warm The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it... Read more
The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it was on fire. I had a rash on the opposite arm that i had the injection. I took benadryl to help with the rash in the morning and at night. That night i was freezing and i woke up in a sweat. This morning i woke up and the rash looks worse.
29 2021-01-28 vaccination site pain This is a spontaneous report from a non-contactable nurse. A 29-years-old female patient received bn... Read more
This is a spontaneous report from a non-contactable nurse. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), intramuscular the first dose on arm left on 23Dec2020 09:00 am, the second dose on right arm on 14Jan2021 09:00 am, both at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (MOTRIN [IBUPROFEN]). The patient experienced pain injection site, fever of 102.2, malaise, all on an unspecified date with outcome recovered. Therapeutic measures were taken as a result of pain at injection site. The patient underwent lab tests and procedures which included Covid test with nasal swab: negative on 16Jan2021. The patient is not pregnant. No follow-up attempts are possible. No further information is expected.
29 2021-01-28 redness raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneou... Read more
raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.
29 2021-01-28 injection site hardening, injection site redness, injection site pruritus red circle around the injecting site; injecting site, itchy; injecting site; a hard ball underneath;... Read more
red circle around the injecting site; injecting site, itchy; injecting site; a hard ball underneath; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El3246 and expiry date unknown) via unspecified route of administration at the left arm on 13Jan2021 09:15 at single dose for Covid-19 immunization in a hospital. Medical history included liver tumors, and allergies to "sulfer", thyroid (disorder), anxiety and blood pressure (abnormal). Concomitant medications included thyroid, anxiety and blood pressure medications. The patient has no other vaccine in four weeks. On 14Jan2021, the patient experienced red circle around the injecting site, itchy and a hard ball underneath. The patient did not receive treatment due to the events. The outcome of the events red circle around the injecting site, itchy and a hard ball underneath was not recovered.
29 2021-01-28 vaccination site redness the redness around the site came back; the redness around the site came back; headache; body aches; ... Read more
the redness around the site came back; the redness around the site came back; headache; body aches; chills; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3246 and Expiration Date unknown) via intramuscularly on 12Jan2021 08:15 AM (Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via intramuscularly on 21Dec2020 05:15 PM (Right arm) at single dose for COVID-19 immunisation. With first dose, patient had redness to the site the day after injection. It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine, the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large (have pictures for comparison throughout the days). Treatment included oral antibiotic and it slowly began to fade and go away. Other medical history was reported as Attention deficit hyperactivity disorder (ADD), eczema, psoriasis. The concomitant medications included unspecified Birth control, vitamin b complex (VITAMIN B) and ergocalciferol (VIT D). No other vaccine in four weeks. After second vaccine patient had a typical immune response- headache, body aches, chills, etc on the first day after vaccination and then on the second day post vaccination the redness around the site came back. Patient worried it was going to continue to grow again. The outcome of events was unknown.
29 2021-01-29 injection site pain Constant stomach pains with a continuous loop of constipation and diarrhea. High levels of pain thro... Read more
Constant stomach pains with a continuous loop of constipation and diarrhea. High levels of pain through the left arm and around the injection site.
29 2021-01-29 skin warm, itchy skin, rash, rash macular Mild itching, fatigue, rash, muscle aches. Moderate headache. Patient described rash as red blotchy ... Read more
Mild itching, fatigue, rash, muscle aches. Moderate headache. Patient described rash as red blotchy spots on forehead and sides of her temple. Ears also were hot to touch.
29 2021-01-29 injection site pain, rash, injection site redness Pain and redness at injection site, tachycardia, dyspnea on exertion, fatigue, rash on face
29 2021-01-29 hives, injection site pruritus, injection site redness, injection site pain, injection site warmth Red welt over injection site, slowly growing bigger every few hours. It?s hot, sore and itchy. Just ... Read more
Red welt over injection site, slowly growing bigger every few hours. It?s hot, sore and itchy. Just started showing as of 1/29/2021...as of now it is the size of a kiwi. When vaccine was administered, doctor must of hit a blood vessel. I bled down my arm.
29 2021-01-30 itchy skin I got the 1st Pfizer vaccine on 1/6/21, I had mild itching and fleeting chills after the shot. I too... Read more
I got the 1st Pfizer vaccine on 1/6/21, I had mild itching and fleeting chills after the shot. I took some Benadryl when I got home, and I was ok. I got the 2nd vaccine on 1/27/20 at 8 am. At around 8:10 I started getting itchy. The itching escalated, and I notified one of the nurses at the vaccination clinic. At around 8:32 they administer Claritin and called the rapid response team because I started having tightness in my chest (similar to my asthma reaction). The Physician who responded to the rapid response recommended that I be transferred to the ER for observation. I was taken to the ER and was given IV fluids with Solu-Medrol, Pepcid, and Benadryl. I had some improvement, but still experienced some mild itching, which is still ongoing (as of today 1/31/21 @ 01:47). I?ve had a headache and fatigue the past 2 days, the headache has resolved, but still feeling fatigued. I was prescribed prednisone and I am to take Benadryl as needed. I have been compliant with all my prescribed meds. I had a follow up with my PCP on 1/28/21 @ 8:10, she recommended that I continue taking the medications prescribed in the ER, and to follow up with the office for further assistance or go back to the ER if I have tightness in my chest. She also recommended taking Tylenol for the headache. As of this morning (1/31/21 02:05), I have not had tightness in my chest. I've been using my prescribed Inhalers (both the flovent and albuterol).
29 2021-01-30 itchy skin, injection site reaction, redness, skin warm, hives, injection site pruritus, hardening Immunization Admin. COVID-19 30mcg/0.3mL Dosage 1st Dose Pfizer (Z23); ­COVID-19 Vaccine, 30 Mcg/0.... Read more
Immunization Admin. COVID-19 30mcg/0.3mL Dosage 1st Dose Pfizer (Z23); ­COVID-19 Vaccine, 30 Mcg/0.3mL Dosage, Diluent Reconstituted, For Intramuscular (Z23) (IM injection) Manufacturer Pfizer Lot EL3249 Expiring 05/01/2021 ­ Vaccination received on 1-12-21, left deltoid. She had localized stinging in left proximal lateral arm for first 12-24 hrs; then itchy welt at injection site and nearby separate itchy small area on proximal lateral arm on 1-13-21. Progressive increase in size/persistent itching. Evaluated on 1-19-21. Afebrile. There is 2x2.5 cm mildly tender, slightly indurated nodularity surrounded by 10x9 cm confluent erythema demarcated by pen, which has extended to 12x9.5 cm in widest margins. Confluent erythema is slightly warm to touch, nontender, nonindurated, no red streaks. No left axillary adenopathy. Treated with antihistamines.
29 2021-01-31 rash, skin spots After 7 days, a full body rash developed along with petechia on bilateral calf and bilateral upper a... Read more
After 7 days, a full body rash developed along with petechia on bilateral calf and bilateral upper arm. Current treatment is antihistamines and pramoxine lotion
29 2021-01-31 hives, itchy skin I have been extremely itchy all day. It hasn?t been around the injection site. I had hives for abou... Read more
I have been extremely itchy all day. It hasn?t been around the injection site. I had hives for about an hour then they went away but the itching stayed. I had it on my head, stomach, chest, wrists, neck, feet and back. I spoke with a pharmacist and took Benadryl and it helped.
29 2021-01-31 injection site pain Injection site pain, headache, fatigue, vomiting, diarrhea
29 2021-01-31 injection site inflammation, injection site pruritus, injection site hardening, injection site redness, injection site warmth the redness came back but it was itchy, hot to touch, and hard; the redness came back but it was itc... Read more
the redness came back but it was itchy, hot to touch, and hard; the redness came back but it was itchy, hot to touch, and hard; With my first vaccine I had redness to the site the day after injection; It was probably about a quarter to half dollar in size and was red and inflamed; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the right arm on 21Dec2020 17:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADD), eczema, and psoriasis; all from an unknown date. Patient was not pregnant. Concomitant medications included vitamin b complex, ergocalciferol (VIT D), and birth control. It was reported that with patient's first vaccine, the patient had redness to the site the day after injection (22Dec2020). It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine (reported as '27Dec2020 19:00'), the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large. The patient visited a physician, and was placed on an oral antibiotic and it slowly began to fade and go away. The outcome of the events was recovered.
29 2021-02-01 injection site pain Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibupr... Read more
Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection. Received vaccine at 9:15 AM. She initially felt well, but about 20-30 minutes after administration began to feel dizzy. Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration. Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx. However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain. By 11:08 no longer had symptoms except for arm pain. By 11:43 still feeling back to normal except for arm pain.
29 2021-02-01 itchy skin, injection site redness, injection site swelling Eight days after I received the first dose I experienced redness and swelling around the injection s... Read more
Eight days after I received the first dose I experienced redness and swelling around the injection site. It continued to get larger over the next two days, measuring 4 inches in diameter. It was associated with mild pruritis. There was diffuse swelling of the area but no discrete fluid collection. I couldn't lift my left arm above shoulder height by the end of the second day. After discussion with our infectious disease doctor and an internist we decided that since the area had continued to get larger that I should have a steroid injection. I received 40mg IM solumedrol two days after it appeared and it markedly improved 6 hours later with resolution of symptoms about 24 hours later.
29 2021-02-01 injection site pain Site: Pain at Injection Site-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Oth... Read more
Site: Pain at Injection Site-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Other- Light-headed, numbness ONLY in lower hand and wrist-Medium
29 2021-02-01 hives hives/hives on her lower legs with sporadic patches on other places of her body including her upper ... Read more
hives/hives on her lower legs with sporadic patches on other places of her body including her upper legs, some on her arm, some on her torso and her upper chest; soreness (a little bit); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Unknown lot number and expiration), intramuscular in left upper arm on 31Dec2020 at a single dose for COVID-19 prophylaxis. Medical history included cat allergy/seasonal and animal allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for cat allergy. The patient previously received flu shot for immunization on unspecified date. The patient reported that she received the first dose of vaccine on 31Dec2020 and experienced soreness (a little bit) but was no difference from the flu shot. Last night (18Jan2021), hives started to appear. She took a Zyrtec this morning (19Jan2021) that she usually takes at night to alleviate the symptoms. She takes Zyrtec because she has a cat allergy and also reported to have changed her laundry detergent. The patient was wondering if there have been any reports of delayed allergic reactions to the COVID-19 vaccine. She said that she just got hives on her lower legs with sporadic patches on other places of her body including her upper legs, some on her arm, some on her torso and her upper chest last night. She may have some on her back, but she has not looked yet. She has had this type of reaction before with an antibiotic in the past. She is supposed to get the second dose on Thursday 21Jan2021. She noticed the hives last night and they seem to have gotten a little bit worse overnight but are about the same since she has gotten up. She said that she has allergies, but they are seasonal and animal allergies. She has also been using the same body wash and laundry detergent and stated that nothing has really changed with her. She also said that her partner that lives with her has not had any skin issues. The patient had not yet recovered from the event hives, while unknown outcome for the remaining event. Information on the lot/batch number has been requested.
29 2021-02-02 itchy skin Began experiencing full body itchiness about 1.5 weeks after receiving her first COVID vaccine dose.... Read more
Began experiencing full body itchiness about 1.5 weeks after receiving her first COVID vaccine dose. She takes benadryl at night to help with the symptoms. When the benadryl wears off the symptoms return. Still experiencing itchiness.
29 2021-02-02 rash, rash macular, itchy skin, redness Received Pfizer first dose at 7:52am. While in Observation area of Vaccination Clinic (with a recom... Read more
Received Pfizer first dose at 7:52am. While in Observation area of Vaccination Clinic (with a recommended 30 min observation time), within 15 min patient complained of "Itchy arms". I noticed red, blotchy rash on her chest. She stated her breathing was fine/no issues with breathing. Elevated her feet. BP= 123/85, O2Sats= 98%. Patient said she had pre-medicated with Benadryl and had an Albuterol inhaler and Epi Pen she had brought with her to her Vaccination appointment. She then started clearing her throat. Epi pen recommended for her to take-> she declined, stating her breathing was fine, and its too painful to take and bruises her skin and wasn't having trouble breathing. Patient brought to Emergency room within hospital.
29 2021-02-03 rash, itchy skin, rash with redness, rash macular Patient received Pfizer first dose at 7:52am. Came to Observation area with a recommended 30 min ob... Read more
Patient received Pfizer first dose at 7:52am. Came to Observation area with a recommended 30 min observation time. Within 15 min in OBS area patient complained of ""Itchy arms"". I noticed red, blotchy rash on her chest. She stated her breathing was fine/no issues with breathing. Elevated her feet. BP= 123/85, O2Sats= 98%. Patient had pre-medicated with Benadryl and had an Albuterol inhaler and Epi Pen she had brought with her to her Vaccination appointment. She then started clearing her throat. Epi pen recommended for her to take-> she refused, stating her breathing was fine, and its too painful to take and bruises her skin and wasn't having trouble breathing. Rapid Response called. Again Epi pen recommended- patient declined. She was brought to Emergency room and report given.
29 2021-02-03 rash, hives rash and hives all over body; rash and hives all over body; This is a spontaneous report from a cont... Read more
rash and hives all over body; rash and hives all over body; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EJ1685; expiry date: not known), intramuscular in the left arm on 17Jan2021 08:30 at single dose for COVID-19 immunization. There was no medical history. The patient is not pregnant. No known allergies. Concomitant medication included unspecified medication (other medication given in two weeks). No other vaccine in four weeks. No COVID prior to vaccination and not tested with COVID post vaccination. The patient experienced rash and hives all over body on 18Jan2021 11:00. These resulted in physician's clinic visit. Therapeutic measures were taken as a result of rash and hives all over body with prednisone, Benadryl, and Kenalog. The outcome of the events was recovered in Jan2021.
29 2021-02-04 rash Broke out into a full body itchy rash several hours after receiving vaccine. Went to emergency room ... Read more
Broke out into a full body itchy rash several hours after receiving vaccine. Went to emergency room for visual examination. Was determined to be a mild allergic reaction, and benadryl was administered. Was evaluated at primary care doctor after rash did not go away after 2 days. No additional treatment was administered. Rash went away after 4 days. Also, 12 hours after receiving the vaccine I had severe fatigue, chills, nausea/vomiting, and headache. Was treated at home with advil and promethazine. These symptoms went away around 36 hours after vaccine was administered.
29 2021-02-04 vaccination site pain RIGHT ARM VERY SORE; This is a spontaneous report from a contactable nurse (patient). A 29-year-old... Read more
RIGHT ARM VERY SORE; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on Right arm from 04Jan2021 14:30 to 04Jan2021 14:30 at SINGLE DOSE (first dose) for covid-19 immunisation. Medical history included PCOS, hypothyroidism, hyperparathyroidism, hypertension. The patient has allergies with amoxicillin and oxybenzone. The patient experienced right arm very sore on 05Jan2021 with outcome of recovered. The patient is not pregnant at the time of vaccination. No treatment was received for the event. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
29 2021-02-04 itchy skin, rash with redness erythematic rash to torso, itching, T 103, body aches. Saught tx with urgent care, tx oral steroids.... Read more
erythematic rash to torso, itching, T 103, body aches. Saught tx with urgent care, tx oral steroids. Then resolved after 2 days sterids tx felt much better.
29 2021-02-05 rash, itchy skin, skin warm Itching, rash on arm that was injected its hot.
29 2021-02-05 hives, itchy skin Mild hives on left forearm day 1, took loratidine. Moderate hives on both forearms after 7 days. Con... Read more
Mild hives on left forearm day 1, took loratidine. Moderate hives on both forearms after 7 days. Continue to have itchy legs and hives in forearms.
29 2021-02-05 rash Patient Experienced rash within 1 hour of vaccination dose
29 2021-02-06 injection site pain Severe pain at injection site, moderate headache, fatigue and chills
29 2021-02-07 rash Chest tightness, elevated BP, rash
29 2021-02-07 hives Mouth swelling; hives in mouth and lips; Body aches; joint pain; chills; This is a spontaneous repor... Read more
Mouth swelling; hives in mouth and lips; Body aches; joint pain; chills; This is a spontaneous report from a (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration in left arm on 14Jan2021 11:45 at first single dose for COVID-19 immunization. Medical history included covid-19 (covid prior vaccination), known allergies: Penicillin, sulfa drugs. There were no concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced body aches, joint pain and chills began about 16 hours after receiving vaccine (15Jan2021). Mouth swelling and hives in mouth and lips began 4 days after (18Jan2021 10:00 AM). AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment included: prescribed steroids. Covid was not tested post vaccination. Outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
29 2021-02-07 vaccination site pain Sore throat; headache; severe pain at injection site; body aches; congestion/runny nose; congestion/... Read more
Sore throat; headache; severe pain at injection site; body aches; congestion/runny nose; congestion/runny nose; fever; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient receive the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248) in the hospital, via an unspecified route of administration on 19Jan2021 at 15:15 on the left arm at a single dose for COVID-19 immunization. Medical history included migraine with aura from an unknown date and unknown if ongoing. Concomitant medication included unspecified prenatal vitamins. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient experienced sore throat, headache, severe pain at injection site, body aches, congestion/runny nose and fever all on 19Jan2021 at 17:30. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious. The patient underwent a post vaccination COVID test via nasal swab on 21Jan2021 with a negative result.
29 2021-02-08 itchy skin Approximately an hour after vaccine administration I developed a scratchy throat. Soon after I felt ... Read more
Approximately an hour after vaccine administration I developed a scratchy throat. Soon after I felt like my eyes were swollen, though not swollen visibly. I also had mild itching across my arms. These symptoms improved within 3-4 hours without medical intervention.
29 2021-02-08 hives Hives present on both forearms and both calves. Steroid cream used.
29 2021-02-08 rash On 2/5/21 patient received Pzifer COVID-19 dose #2 early afternoon at workplace clinic. On 2/9/21 pa... Read more
On 2/5/21 patient received Pzifer COVID-19 dose #2 early afternoon at workplace clinic. On 2/9/21 patient reported beginning 2/5/21 early evening she began having overall body rash and body ache that progressed over the next few days to sore/swollen throat, voice loss, nausea, intermittent fever, loss of taste and smell, headache, and diarrhea. Tested COVID-19 negative 2/9/21, still having symptoms. Stated has not seen her healthcare provider but will contact for care.
29 2021-02-08 injection site pain fatigue, fever, chills, aches, sweats, injection site soreness. Onset 8-10 hours post-vaccine, laste... Read more
fatigue, fever, chills, aches, sweats, injection site soreness. Onset 8-10 hours post-vaccine, lasted 48 hours to varying degrees of severity.
29 2021-02-08 hives, itchy skin trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient exper... Read more
trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient experienced itching on legs arms and face along with hives; Headache getting severe by the minute; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received 2nd dose of bnt162b2 (BNT162B2; lot number EN5318) on 25Jan2021 intramuscular at right arm for COVID-19 immunization. Medical history was not reported. The patient had no COVID prior to vaccination. Historical vaccine include BNT162B2 for COVID-19 immunization. The patient had no other vaccine in weeks, concomitant drugs was none. The patient experienced headache getting severe by the minute. Patient experienced itching on legs arms and face along with hives and trouble breathing. Event start date was 25Jan2021. One epinephrine was received. Patient was taken to the hospital. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events headache, dyspnea, urticaria and pruritus are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-02-09 rash Rash on neck; This is a spontaneous report from a contactable other healthcare professional (patient... Read more
Rash on neck; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 21Jan2021 at a single dose on right arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 29Dec2020 for COVID-19 immunization (brand: Pfizer, lot number: EL1284, administration time: 02:45 PM, route: intramuscular, vaccine location: left arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on neck on 23Jan2021 09:00. The event was reported as non-serious. The patient has not been tested for COVID since the vaccination. No treatment was received for the adverse event. The patient has not recovered from the event.
29 2021-02-09 rash, vaccination site rash Rash on right side of neck; Rash of bumps on the left arm where injection happened; Rash of bumps on... Read more
Rash on right side of neck; Rash of bumps on the left arm where injection happened; Rash of bumps on the left arm where injection happened; Some difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 22Jan2021 13:30 at single dose for COVID-19 immunization. Medical history included asthma, allergies and migraine. Concomitant medication included ibuprofen, albuterol [salbutamol] and sumatriptan. The patient previously took clindamycin and experienced drug allergy. The patient experienced rash of bumps on the left arm where injection happened, rash on right side of neck some difficulty breathing on 22Jan2021 19:30. The patient received treatment Benadryl and albuterol to treat symptoms. The outcome of events was recovered in Jan2021. Information on the Lot/Batch number has been requested.
29 2021-02-10 hives After second shot had numbness on the left side of face approximately ten minutes after shot, was le... Read more
After second shot had numbness on the left side of face approximately ten minutes after shot, was less numbness than shot one. Approximately 3 hours after shot developed hives on same area of face that was number. Hives last about 2 hours and cleared up with OTC Benadryl. Face numbness stopped about 6.5 hours after injection
29 2021-02-10 rash, blister, hives, hardening, injection site reaction anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feelin... Read more
anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.
29 2021-02-11 hives Hives 4 days after first dose that was self-limiting and resolved with Benadryl, reported at time of... Read more
Hives 4 days after first dose that was self-limiting and resolved with Benadryl, reported at time of 2nd dose
29 2021-02-14 skin discolouration Left second toe became discolored and stinging/painful, then left 4th toe. Exam c/w pernio/chillblai... Read more
Left second toe became discolored and stinging/painful, then left 4th toe. Exam c/w pernio/chillblains
29 2021-02-14 injection site warmth, injection site swelling, injection site redness Swelling,heat, and redness at injection site. Severe headache, fever of at least 101.5, chills, ach... Read more
Swelling,heat, and redness at injection site. Severe headache, fever of at least 101.5, chills, aches, lethargy, inappetence.
29 2021-02-14 rash, vaccination site pain the arm i received the injection felt like it was on fire; The opposite arm had a rash on it; I was ... Read more
the arm i received the injection felt like it was on fire; The opposite arm had a rash on it; I was freezing at night and i woke up in a sweat; I was freezing at night and i woke up in a sweat; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old. Lot number was EL9262. Medical history was none. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old (lot number was EL3248). Concomitant medications included desogestrel, ethinylestradiol (ISIBLOOM) for birth control, ESCITALOPRAM OXALATE (LEXAPRO), vitamin D. On 28Jan2021 at 07:45, the patient woke up and the arm where she received the injection felt like it was on fire; the opposite arm had a rash on it; the patient took benadryl that morning and at night after she got home from work. On 28Jan2021, the patient was freezing at night and he woke up in a sweat. On 29Jan2021, the rash looks worse. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
29 2021-02-15 itchy skin PFIZER-BIONTECH COVID-19 . Individual had nausea/vomiting, fever 101.6, fatigue and body aches x 48 ... Read more
PFIZER-BIONTECH COVID-19 . Individual had nausea/vomiting, fever 101.6, fatigue and body aches x 48 hours following first dose on 1/20/21. After second dose of vaccine, reported: itching, stridor, cough, nausea, vomiting, dizziness, tachycardia, acute change in mental status, temp102.5, DBP >100, tremors for 48 hours. Did not see doctor or other healthcare provider.
29 2021-02-16 bruising Between the first and second dose (1/11/21), I had significant bruising on my body. I was also light... Read more
Between the first and second dose (1/11/21), I had significant bruising on my body. I was also light headed from time to time with decreased appetite, anxiety and heart burn. I went in for blood work and my platelet count had dropped to 5 and I was asked to come into the ER for platelet transfusion. I also received IVIG (x1) + steroid treatment (x2) and took oral steroids 4 days after.
29 2021-02-17 vaccination site pain This is a spontaneous report from a contactable other health care professional (patient self-reporte... Read more
This is a spontaneous report from a contactable other health care professional (patient self-reported). A 29-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3247 and expiry date was not provided), via an unspecified route of administration, at arm Right on 26Jan2021, at a single dose for COVID-19 immunization, in Workplace clinic. Patient's medical history was reported as none and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not received any other vaccines within 2 weeks of vaccination of COVID vaccine. On same day (26Jan2021), the patient experienced soreness in right arm and it is persistent after 24hours. Patient was not received any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Seriousness of the event was reported as non serious. Outcome of the event was recovering.
29 2021-02-18 injection site pain 2/18/2021 4:30am woke up nauseous, having muscle aches from injection site in left bicep to top of h... Read more
2/18/2021 4:30am woke up nauseous, having muscle aches from injection site in left bicep to top of head on same side, not able to think clearly ?foggy?. 1:30pm having muscle aches in both sides of neck and headache left sided
29 2021-02-21 injection site pain High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache a... Read more
High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache and dizziness, shaking, muscle cramps (all lasted about 24 hours straight through. Muscle and joint pain and weakness continued through 48 hours. Left arm, under arm and shoulder were very tender and mobility restricted through day 3.
29 2021-02-21 rash She developed flu like symptoms the day after receiving the vaccine, including, fever, chills, nause... Read more
She developed flu like symptoms the day after receiving the vaccine, including, fever, chills, nausea, vomiting, fatigue, myalgias, rash, which have persisted for 6 days.
29 2021-02-22 itchy skin, rash, hives Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to wa... Read more
Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to walk on feet and use hands.
29 2021-02-22 injection site numbness Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. Aft... Read more
Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. After about 20 minutes the numb like feeling had begun to regress back toward the injection site. It had not fully faded away after 30 minutes but did seem to be improving.
29 2021-02-22 redness, rash, injection site rash, hives Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives... Read more
Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives on face and behind ears and some on shoulders and arms client took Benadryl by pm the face was red without hive and by Sunday the Hives had disappeared. Monday redness on face and by Tuesday all hives had resolved. Tuesday still very weak and fatigued and if sits upright HR increases, eating and drinking without interruption.
29 2021-02-23 itchy skin Fever, swollen lymph nodes, itchy skin, intense body acne (increased swelling and discharge from exi... Read more
Fever, swollen lymph nodes, itchy skin, intense body acne (increased swelling and discharge from existing infections), muscle aches, body pain, prolonged fatigue, brain fog, persistent migraines, sweating, chills. All persisted for about a week.
29 2021-02-23 redness, hardening Red, swollen, hard lump the size of a baseball for 1 week
29 2021-02-23 vaccination site swelling, vaccination site pain Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Ir... Read more
Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Irritated; This is a spontaneous report from a non-contactable nurse (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration on the left arm on 21Jan2021 22:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Dec2020 for COVID-19 immunization. On 22Jan2021 03:00 AM, the patient experienced site swelling and high pain for 3 days. Global Migraines that I have never hard before 2 days after vaccination and irritated. Events treatment included paracetamol (TYLENOL), cetirizine (ZYRTEC) and diphenhydramine (BENADRYL). Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
29 2021-02-24 hives, itchy skin HIVES, ITCHY NECK, SWOLLEN LYMPH NODES, SCRATCHY THROAT, TINGLING IN THROAT
29 2021-02-25 injection site warmth, injection site redness, injection site swelling Muscle pain across shoulders starting at 2pm after 9 am shot on 2/23. COVID arm, large red bump on a... Read more
Muscle pain across shoulders starting at 2pm after 9 am shot on 2/23. COVID arm, large red bump on arm, warm to touch and hot following morning, noticed at 7 am on 2/24. Under arm, armpit and down into rib area sore when arm is raised, noticed 7 am 2/24 pain gets worse throughout day. Pain in upper back across shoulders as well during day. All listed above is still ongoing at the same pain level.
29 2021-02-25 redness Patient felt nervous, difficulty breathing and complained about swelling in the back of the throat w... Read more
Patient felt nervous, difficulty breathing and complained about swelling in the back of the throat within 15 minutes of administration. Her face was red and heart rate was elevated to 120bpm with blood pressure of 140/90mmhg.
29 2021-02-25 injection site pain, rash Rash starting in center of chest and under breasts, spread to stomach, and spanned across sides of t... Read more
Rash starting in center of chest and under breasts, spread to stomach, and spanned across sides of torso onto back. Spread mildly onto shoulder/neck. Pain/soreness at injection site, started a few hours after injection, and subsided a few days after injection.
29 2021-02-25 vaccination site pain Rigors; pain at injection site; body aches; This is a spontaneous report from a non-contactable nurs... Read more
Rigors; pain at injection site; body aches; This is a spontaneous report from a non-contactable nurse reporting for herself. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-year-old via intramuscular in the left arm on 28Jan2021 01:00 PM at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient experienced rigors, pain at injection site, body aches on 29Jan2021 at 03:00 AM. No treatment was received for the events. The nurse considered the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
29 2021-02-27 injection site pain Currently pregnant (25 weeks) due June 9, 2021 - no known adverse events in the pregnancy. Injectio... Read more
Currently pregnant (25 weeks) due June 9, 2021 - no known adverse events in the pregnancy. Injection site soreness, Vasomotor symptoms, nausea. Injection site soreness lasted 48 hours. Other symptoms lasted approximately 45 minutes.
29 2021-03-01 hives, rash, itchy skin My mouth and tongue started itching; Skin broke out in a rash and became super itchy; Skin broke out... Read more
My mouth and tongue started itching; Skin broke out in a rash and became super itchy; Skin broke out in a rash and became super itchy; Have hives; This is a spontaneous report from a consumer reporting for herself. A 29-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # em9809) vaccine , via an unspecified route of administration in the left arm on 24Feb2021 14:30 at single dose for covid-19 immunisation . Medical history included asthma , attention deficit hyperactivity disorder , polycystic ovaries , sleep apnoea syndrome, arthralgia , the patient was allergic to Albuterol, Penicillin, Cephalosporin, Iodine, Bees, all types of fish, all types of shellfish, peanuts, all types of tree nuts. Concomitant medication included cefixime (FLEXERIL), acetylcarnitine hydrochloride (NEUROTIN ), naproxen (MOTRIN). The patient experienced my mouth and tongue started itching on 24Feb2021 14:30 with outcome of not recovered , skin broke out in a rash and became super itchy on 24Feb2021 14:30 with outcome of not recovered , have hives on 24Feb2021 14:30 with outcome of not recovered. The reported events were considered Life Threatening. The patient received Benadryl, and got epi on hand as treatment. Follow up information has been requested.
29 2021-03-02 rash, itchy skin Rash on arms and legs, itchy, currently has lasted 7+ days
29 2021-03-03 hives Immunization administered on 12/27/2020. On 01/04/2021 I began to break out in full body urticaria w... Read more
Immunization administered on 12/27/2020. On 01/04/2021 I began to break out in full body urticaria with facial edema and joint pain. Followed up with allergist and rheumatology. Both ruled out allergy or rheumatological causes. Elevated CRP of 116. Ongoing urticaria outbreak since onset.
29 2021-03-04 injection site swelling, injection site pain Injection site pain, tiredness after 30 minutes, muscle pain in right arm, - joint pain, injection s... Read more
Injection site pain, tiredness after 30 minutes, muscle pain in right arm, - joint pain, injection site swelling, nausea, and headache.
29 2021-03-05 hives Patient with prior hx of anaphylaxis - required 30 min wait, ~ 25 mins into wait time - reporting sl... Read more
Patient with prior hx of anaphylaxis - required 30 min wait, ~ 25 mins into wait time - reporting slight swelling of lips, sensation of itchy throat/tightening, appearance of hives on arms. Patient alert and oriented, breathing comfortably. Advised will take to ED dept for further evaluation - patient refusing wheelchair - ambulatory. Walked to ED dept with NP, report given to ED, registration completed.
29 2021-03-05 injection site tingling Tingling sensation injected arm
29 2021-03-06 hives, rash Patient presented for her first covid vaccine today. She received the immunization in her right delt... Read more
Patient presented for her first covid vaccine today. She received the immunization in her right deltoid at 1703, was seated in the 15 minute observation area. After about 10 minutes, she reported feeling dizzy. RN alerted EMS who brought her for closer evaluation. While in EMS care, patient developed rash and hives on her neck and arms, swelling in her lips and tongue, shortness of breath with oxygen saturations in the 80's. EMS started a 20g Left antecubital IV, administered 50 mg benadryl IM, 125 mg solumedrol IV, placed patient on supplemental oxygen at 2L nasal canula. After medication administration, patient's rash and hives began to resolve and she was able to speak clearly after medication. Patient was transported to hospital via ambulance for further evaluation. VAERS documented.
29 2021-03-07 injection site redness, injection site pruritus After 30 minute observation period, pt. remoed her bandaid and stated she had a slight itching at th... Read more
After 30 minute observation period, pt. remoed her bandaid and stated she had a slight itching at the injection site. Slight redness noted, but pt. had been scratching. No swelling. Denied any other symptoms and states has had allergic reactions before and this didn't feel like one. Pt. was instructed to go to the ED if she had any worsening or concerning symptoms. Pt. verbalized understanding.
29 2021-03-07 hives diffuse urticaria about 3 hrs post injection
29 2021-03-08 injection site bruising, injection site nodule I started to have heart palpitations with a high heart rate. I called in to my telehealth and was to... Read more
I started to have heart palpitations with a high heart rate. I called in to my telehealth and was told that it was vaccine related. It subsided after 36 hours. After the second dose I had flu like symptoms and brain fog for a day. I had bruising and a knot at the injection site that lasted for three weeks.
29 2021-03-09 hives 2 hours after the injection, patient developed hives on arms/legs. She took a benadryl and symptoms ... Read more
2 hours after the injection, patient developed hives on arms/legs. She took a benadryl and symptoms resolved. She had no previous allergic reactions.
29 2021-03-09 redness, rash, itchy skin, bruising Pfizer-BioNTech COVID-19 Vaccine EUA. Severe and unusual skin itchiness, scratching resulted in imme... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Severe and unusual skin itchiness, scratching resulted in immediate bruising, patchy red skin, itchy throat and ears, fatigue, soreness, achiness Took benadryl and napped. Later took tylenol and ibuprofen
29 2021-03-09 rash papular, hives, itchy rash Raised rash that itches on skin only on areas where there are tattoos. Raised largest rash that itch... Read more
Raised rash that itches on skin only on areas where there are tattoos. Raised largest rash that itches stops at tattoo boarders. Swelling has caused the tattoos to swell up. Smaller rash bumps can be seen on top of tattoos that look different from the large welts. Primarily only on tattoos. OTC Topical cortisone cream has not relieved itching or welts. Prescription Topical Triamcinolone Acetonide Cream 0.1% has not made any changes.
29 2021-03-09 vaccination site pain sore neck; fatigue; Sore arm muscle at injection site; This is a spontaneous report from a contactab... Read more
sore neck; fatigue; Sore arm muscle at injection site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in arm left, on 18Feb2021 15:00, as single dose for COVID-19 immunization, at workplace clinic. Patient's medical history included Asthma, Herpes, Bipolar 2 Disorder. Patient had no Allergies to medications, food, or other products. Concomitant medications included valacyclovir, montelukast and lamotrigine (within two weeks of vaccination). Historical vaccine included first dose of BNT162B2 (lot number; unknown), via an unspecified route of administration, in Left arm, on 28Jan2021 3:00 PM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 18Feb2021 15:00, the patient experienced sore arm muscle at injection site after injection and continuing into second day (19Feb2021); sore neck and fatigue starting the next morning. Patient was not received treatment for adverse events. Seriousness of the events was reported as non-serious. Outcome of the events was recovering. Information on the lot/batch number has been requested.
29 2021-03-10 redness Approximately 3 to 4 minutes after receiving vaccine, patient stated she was not feeling good and pa... Read more
Approximately 3 to 4 minutes after receiving vaccine, patient stated she was not feeling good and patient turned red and fainted. She was sitting in chair so mom stood behind her with an ice pack behind neck and holding patient head while dad stood in front of patient. Her body became limp and mom was shaking her body on right side in attempt to wake patient up. Her eyes opened but was still unresponsive and she was breathing heavily for 30-40 seconds. After placing patient on floor and elevating her legs, patient stated she felt better but still fills nauseated. Paramedics were called.
29 2021-03-10 itchy skin Hot flashes. Body is hot. Itchy skin. Scratchy throat. Fuzzy tongue.
29 2021-03-11 itchy skin Patient was brought to me by nurse who was with patient in waiting area when she became anxious afte... Read more
Patient was brought to me by nurse who was with patient in waiting area when she became anxious after receiving Phizer COVID 19 vaccine. She was alert and oriented when I placed her in the sitting position on an exam table in the observation area. approximately 20 minutes later, she reported feeling itchiness in nose and lips. There was no swelling, redness noted. There was no rash, SOB, difficulty swallowing. She has taken Benadryl for similar symptoms in the past and requested she be given some. She was given Benadryl 50mg PO. VSS through out. Symptoms resolved over next 20 minutes. She was asymptomatic at 1210 and was discharged with sister to drive home.
29 2021-03-12 injection site reaction The muscle around the injection site was very stiff shortly after the injection. No pain to touch ar... Read more
The muscle around the injection site was very stiff shortly after the injection. No pain to touch around injection site. On 3/6/21 I started experiencing slight pain in my axillary region. Pain was probably 3 of 10. Stayed at this pain level until 3/8, when it started to increase and to date pain is increasing and there is a large lump in my under my arm. Lifting my arm above my shoulder increases pain. Pain also wraps around to my shoulder area. I have never had any pain in or around this region until after the vaccine.
29 2021-03-12 hives The night of vaccination I felt awful like I had the flu and got hives up and down my legs. Since th... Read more
The night of vaccination I felt awful like I had the flu and got hives up and down my legs. Since then I have felt malaise and general soreness as well as intermittent headaches etc. none of this is uncommon in my body (as I have autoimmune issues). But I am concerned it?s triggered an autoimmune flare. I no longer have hives (so I will check recovered) but still feel unwell.
29 2021-03-14 shingles Shingles in the chest at the level of T4.
29 2021-03-14 injection site pain soreness at the injection site (persisted 48 hours after injection), tired (persisted for 24 hours a... Read more
soreness at the injection site (persisted 48 hours after injection), tired (persisted for 24 hours after injection), headache (began approximately 14 hours after injection and persisted for 12 hours), body aches (began 14 hours after injection and persisted for 12 hours), fever (began 14 hours after injection and persisted for approximately 12 hours), chills (began 14 hours after injection and lasted for approximately 6 hours), nausea (began 16 hours after injection and lasted for approximately 12 hours) No treatments were done. No medications were taken at the direction of the vaccine provider who directed that Tylenol should only be taken with a high grade fever in order to promote a full immune response. Mild dehydration 36 hours following injection likely due to nausea decreasing intake of food and liquids.
29 2021-03-15 blister, shingles, rash 13 weeks pregnant, healthy. Rash start evening of vaccine, progressively worsened over the weekend,... Read more
13 weeks pregnant, healthy. Rash start evening of vaccine, progressively worsened over the weekend, went to a dermatologist 4 days after vaccine with severe and widespread blisters on chest and back, diagnosed as shingles.
29 2021-03-15 injection site rash, rash, skin spots, itchy skin Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on lef... Read more
Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on left chest and shoulder with muscle pain. Left arm became numb, rash at injections site, migraine, numb lips and mouth. Persisted and progressed to vomiting and diarrhea, tachycardia and tachypnea. On 1/14, petechiae around both eyes, widespread muscle and joint pain, tachycardia and tachypnea persist, unable to lift left arm, itchy face, nose and throat. 1/15 Tachycardia persists, migraine, diarrhea, sudden onset vaginal bleeding. 1/16 elevated blood pressure, tachycardia and tachypnea, found unresponsive in bed by my husband and taken to the emergency room.
29 2021-03-16 rash Developed a small light rash on Chest, near elbow and forearm, and above belly button. I have NOT go... Read more
Developed a small light rash on Chest, near elbow and forearm, and above belly button. I have NOT gone to the doctor the get it checked. I have NOT develop any breathing issues just the light rash.
29 2021-03-17 injection site pain Onset within minutes: dizziness, confusion, and facial numbness in both cheeks, eyes, nose, jaw and ... Read more
Onset within minutes: dizziness, confusion, and facial numbness in both cheeks, eyes, nose, jaw and muscle stiffness in the face which lasted until the following day. Following morning, there was sharp pain at the injection site and I was unable to lift my arm at all. In the evening I can lift it half way. Still experiencing 32 hours later: headache and brain fog and dissociated feeling, fatigue, and body aches. Neck remains stiff. Never had any adverse or allergic reaction to anything before and didn't become fully aware that something wasn't right until after I left the facility yesterday.
29 2021-03-17 hives, itchy skin Patient pre-medicated for vaccine with 25mg Benadryl Immediately developed itchy hives. Went to the ... Read more
Patient pre-medicated for vaccine with 25mg Benadryl Immediately developed itchy hives. Went to the ER, was given Benadryl, Pepcid, and Decadron Symptoms resolved To follow up with PCP as needed, take Benadryl/Pepcid as needed
29 2021-03-17 injection site pain Pt received her first dose of Pfizer LOT#: ER2613. Pt contacted EMT and reported that she had heart ... Read more
Pt received her first dose of Pfizer LOT#: ER2613. Pt contacted EMT and reported that she had heart palpitations which lasted about three minutes. Pt also had shoulder pain on left side where she was vaccinated. EMT took vital signs. BP: 118/80, Pulse: 82, 02: 100%. Pt stated that she has had a history of anxiety and high cholesterol. Pt stayed an extra 15 minutes. Pt reassessed, pt stated that she was feeling better. Pt reported that she had not eaten breakfast and requested to have some water. Pt left with husband with a steady gait at 1425.
29 2021-03-18 rash, bruising on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; ... Read more
on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; tingling; bruising; rash; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration in the left arm, on 01Feb2021 08:30, at a single dose, for covid-19 immunization. Medical history included kidney stones, BPD2 (bipolar II disorder), and anxiety; there were no known allergies. Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; and imipramine taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The vaccine was given at the hospital. The patient experienced left side: sharp shooting pains, constant pain; fatigue; numbness; tingling; bruising; rash and; on the legs, hands: nerve damage. All the adverse events happened on 02Feb2021 which resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had not recovered from all the adverse events at the time of the report despite having an unspecified medication and ongoing treatment received for them. The patient also had imaging and labs on Feb2021 for these adverse events with unknown results. The patient has not been Covid-tested post vaccination.
29 2021-03-19 hardening Extremely painful hard lymph node in left armpit
29 2021-03-19 redness My face and neck turned bright red and became very hot. I have pictures for the progress of the redn... Read more
My face and neck turned bright red and became very hot. I have pictures for the progress of the redness if needed too.
29 2021-03-19 hives, injection site reaction On Tuesday the injection site developed hives. On Wednesday I felt very sick. On Saturday I lost all... Read more
On Tuesday the injection site developed hives. On Wednesday I felt very sick. On Saturday I lost all sense of taste and smell.
29 2021-03-19 injection site warmth, injection site tingling PATIENT STARTED TO EXPERIENCE WARMTH AT THE SITE, TINGLING ALONG THE INJECTED ARM, AND DIZZINESS. ST... Read more
PATIENT STARTED TO EXPERIENCE WARMTH AT THE SITE, TINGLING ALONG THE INJECTED ARM, AND DIZZINESS. STAFF NURSES APPLIED COLD PACK TO INJECTION SITE, TOOK VITALS, GAVE PATIENT WATER, MONITORED FOR WORSENING SYMPTOMS. KEPT PATIENT AT SITE FOR OBSERVATION FOR 30 MINUTES.
29 2021-03-19 hives Patient received vaccine and was waiting for 30 minutes in the observation area due to history of al... Read more
Patient received vaccine and was waiting for 30 minutes in the observation area due to history of allergic reactions. At 20-minutes post-vaccination, patient experienced hives and swelling in her tongue. Patient reported to EMS that it felt like previous allergic reactions. EMS assessed VS. BP 151/101, HR 98, O2 sat 97%. EMS administered 1 Epi pen into the R thigh. Patient had a rapid resolution of symptoms. EMS recommended transport to ER, patient agreed. Transported to EMS. Post epi vitals were 150/69, HR 80, O2 Sat 97%.
29 2021-03-20 vaccination site redness, vaccination site swelling Redness and swelling below injection site; Redness and swelling below injection site; This is a spon... Read more
Redness and swelling below injection site; Redness and swelling below injection site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN9581) via an unspecified route of administration in left arm on 07Feb2021 15:00 (at the age of 29-years-old) as single dose for COVID-19 immunisation. Medical history included covid-19. The patient did not receive other vaccine in four weeks prior to vaccination and other medications in two weeks. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3246) in the left arm on 17Jan2021 15:00 for COVID-19 immunisation and amoxicillin and had known allergies. On 08Feb2021 08:00, the patient developed redness and swelling below injection site similar to the "covid arm" from the Moderna vaccine. No treatment was received for the adverse events. The patient did not test COVID post vaccination. The outcome of the events was recovering.
29 2021-03-20 vaccination site swelling, vaccination site warmth Very minor reaction localized to the injection site; the area is hot, swollen, with a few hives; the... Read more
Very minor reaction localized to the injection site; the area is hot, swollen, with a few hives; the area is hot, swollen, with a few hives; the area is hot, swollen, with a few hives; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 13Feb2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. There was no medical history. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included sertraline and bupropion hydrochloride (WELLBUTRIN), both from unknown dates and unknown if ongoing for unknown indications. The patient also received unspecified combination birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced very minor reaction localized to the injection site and the area was hot, swollen, with a few hives on 20Feb2021 at 14:00. Symptoms only appeared 7 days after injection. The patient did not receive any treatment for the events. The clinical outcomes of very minor reaction localized to the injection site and the area was hot, swollen, with a few hives were recovering. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
29 2021-03-21 skin irritation 29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of disc... Read more
29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.
29 2021-03-21 rash, itchy rash Sunday 3/21 (2 days after vaccine): itchy rash on entire neck, shoulder, ears and left abdomen - too... Read more
Sunday 3/21 (2 days after vaccine): itchy rash on entire neck, shoulder, ears and left abdomen - took Claritin and used hydro cortisol cream and the rash subsided. Monday 3/22: mid way through work shift, felt extremely dizzy, jittery and light headed. Difficult to stand and walk on my own and rash started to come back. Went to care.
29 2021-03-22 rash with redness, skin discolouration, itchy skin About an hour after shot in my left arm, I began to experience itchy skin, red bumps on inner elbo... Read more
About an hour after shot in my left arm, I began to experience itchy skin, red bumps on inner elbow on left arm. Now the bumps are discolored and brown/black and I have dark blotch on my inner elbow and the skin is textured
29 2021-03-22 injection site pain High fever, aches, chills, nausea, soreness at injection site, trouble sleeping, headaches, joint pa... Read more
High fever, aches, chills, nausea, soreness at injection site, trouble sleeping, headaches, joint pain
29 2021-03-22 injection site pain I received the shot at 8:30 AM. No reaction until around 12:30PM when I noticed mild soreness in my... Read more
I received the shot at 8:30 AM. No reaction until around 12:30PM when I noticed mild soreness in my arm muscle where I received the shot. Then around 5:30PM I became progressively fatigued and very mildly feverish.
29 2021-03-23 rash macular, injection site reaction Red blotchy patch of skin around injection site, first noticed on 3/20/21 and is still present as of... Read more
Red blotchy patch of skin around injection site, first noticed on 3/20/21 and is still present as of today 3/24/21.
29 2021-03-24 rash Patient reported severe rash on right arm and spread all over neck. No reports of trouble breathing ... Read more
Patient reported severe rash on right arm and spread all over neck. No reports of trouble breathing or hives, just itchiness. Recommended to take an antihistamine and continue to monitor. If any signs of difficulty breathing occur to call 911, if it does not improve over the next 2 days to contact their primary doctor.
29 2021-03-24 injection site pain sore injection site, body aches, low grade fever, general fatigue, swollen lymph nodes (neck), heada... Read more
sore injection site, body aches, low grade fever, general fatigue, swollen lymph nodes (neck), headache at base of skull, swollen and painful left nostril. Patient took 500mg of acetaminophen at 5pm and 9pm and again at 8am the following day. By 11am the next morning, all symptoms except the swollen and painful left nostril and sore injection site resolved. Swelling and pain lessened gradually around 11am and were fully resolved within 72 hours of the injection.
29 2021-03-25 injection site numbness Almost immediately after receiving the vaccine I started feeling numbness in my left arm (injection ... Read more
Almost immediately after receiving the vaccine I started feeling numbness in my left arm (injection site), dizzy, nauseous, and experienced tunnel vision. I also started profusely sweating (forehead). I reported my symptoms to the nurse who took my temperature, BP, and heartrate. I had a low grade fever (99 degrees) and slightly elevated BP. I drank water and remained at the site for another 30 minutes and my vitals were checked again before I left.
29 2021-03-25 hives Broke out in HIVES
29 2021-03-25 skin laceration Patient collapsed onto floor 10min s/p Pfizer vaccination patient stated feeling dizzy and not real... Read more
Patient collapsed onto floor 10min s/p Pfizer vaccination patient stated feeling dizzy and not realizing she fell. Patient has history of fainting after shots but did not advice anyone. Patient got quarter of an in laceration on forehead. Vital signs stable, cleaned and wrapped laceration and sent with paramedics to ER.
29 2021-03-25 itchy skin Patient reported itchiness on her neck, leg . Pt has a history of anaphylaxis. MD administered Zyrte... Read more
Patient reported itchiness on her neck, leg . Pt has a history of anaphylaxis. MD administered Zyrtec PO
29 2021-03-25 injection site pruritus, hives, injection site redness The day of the vaccine I had horrible body aches and horrible nausea as well that lasted approximate... Read more
The day of the vaccine I had horrible body aches and horrible nausea as well that lasted approximately 36 hours. But starting on the 24th so about 11 days post vaccine, my injection site got very red and itchy. The redness then spread down my arm and I developed hives around my elbow. I treated it with a topical Benadryl spray to get rid of the itchiness, and the hives lasted about 36 hours and have already almost faded.
29 2021-03-25 injection site redness, injection site pruritus itchy, redness around injection site. Evaluated by EMS-Cleared
29 2021-03-25 hives patient noted TDAP reaction (hives) in the past, after vaccine reported throat tightness and chest h... Read more
patient noted TDAP reaction (hives) in the past, after vaccine reported throat tightness and chest heaviness, EMS evaluation completed, given benadryl and alleviated and patient self drove himself home.
29 2021-03-26 injection site pain About 3-4 hours after the vaccine (3/25/2021 at 4:20pm) at approximately 8pm, I began to become exh... Read more
About 3-4 hours after the vaccine (3/25/2021 at 4:20pm) at approximately 8pm, I began to become exhausted and had a mild headache of a 1/10 pain. I thought the symptoms could be because I had worked almost a full work day. The next morning of 3/26/2021 at 6:30am, I woke up with injection-site pain (3-4/10 pain) and a worse, but still mild, headache (3-4/10 pain). As the day progressed, I began to feel warm and clammy but had no fever. I took acetaminophen at approximately 7:00pm on 3/26/2021. By the time I woke up on 3/27/2021 at 9am, I felt symptom-free.
29 2021-03-27 itchy skin Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extre... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: itching of neck-Mild, Systemic: Shakiness-Mild
29 2021-03-28 injection site pain Pain at injection site starting approx. 1 hour after injection and continuing yesterday and today (3... Read more
Pain at injection site starting approx. 1 hour after injection and continuing yesterday and today (3/29/21), fever, chills, and headache starting approx. 3-4 hours after injection and lasting approx. 12 hours, joint pain in right knee and right elbow starting approx. 24 hours after injection and continuing today (3/29/21).
29 2021-04-01 itchy skin ?COVID arm? - goose egg appeared; painful to touch and itchy
29 2021-04-09 skin warm, redness Approximately one week after injection I began to experience intense hot flashes. Hot flashes includ... Read more
Approximately one week after injection I began to experience intense hot flashes. Hot flashes include tachycardia, excessive perspiration, reddening of skin, intense warmth of skin and were followed by chills and my color flushing. Also experiencing night sweats that results in insomnia. This has caused a general interruption to my daily life. The hot flashes continued to get more intense over the past several weeks. I have not had my menstrual cycle since my second injection.
29 2021-04-13 skin burning sensation, itchy skin The morning after the vaccine, started with dizziness and vertigo, progressed to burning sensation o... Read more
The morning after the vaccine, started with dizziness and vertigo, progressed to burning sensation of skin. Felt like "burning from inside out." Went to hospital and was admitted on 4/9. Severe itching, nausea, vertigo. Spent 6 days in hospital. Given doses of steroids, Benadryl, pain medications, gabapentin. Discharged on 4/14. Symptoms have not improved.
29 2021-04-16 sensitive skin Everything started on January 24th at about 7pm exactly 20 days post first Pfizer vaccine. No other ... Read more
Everything started on January 24th at about 7pm exactly 20 days post first Pfizer vaccine. No other changes or vaccines given since October (flu vaccine) was scheduled for 1/25/21 for second Pfizer dose. It all started when I was working at ER when I started to feel cold like it was in an ice bath and numbness in both feet. I went to discharge my patients when I realized ascending numbness and coldness from the feet was traveling upward. Within 5 hours (around midnight) I went to hospital due to having severe weakness to where I couldn?t walk and loss of bladder control. I was rushed to MRI of brain, cervical, thoracic, and lumbar. I also had blood work done and a lumbar puncture. I was admitted for a couple days to watching the ascending weakness and loss of feeling. My MRIs came back clear from any diseases such as transverse myelitis, MS, etc. My LP showed mild elevated protein at 54 (normal range 15-45), one tube elevated lymphocytes 100% (range 40-80%) and one tube elevated monocytes 50% (range 15-45%). Also CK-MB w/reflex was 352 (range 26-140). I was discharged on 2/26 at 5:30pm with a diagnosis of bilateral leg weakness and numbness. From this point on I was wheelchair bound at home and being cared for 24/7. After discharge some additional random symptoms started such as chills with no fever to where I slept in sweat pants and sweat shirts, leg spasms/ twitches, leg heaviness, severe lower back and hip pain, a loss of sensation while going pee or poo but not incontinent, and things like drop foot with the severe weakness and numbness . On 2/3/22 I started with double vision, blurry vision and pain behind my right eye. I went to ER and had repeat MRIs of brain, cervical, thoracic and lumbar with and without contrast and basic blood work and was sent home to follow up with Dr. on 2/9 and was discharged home. By 2/8 my strength started to get worse to where I couldn?t lift my kids. Finally saw Dr. neurology and MS specialist 2/9, he ran detailed neuro exams from head to toe, looked at both scans from both hospitals, all the blood work and LP results. He reported that I had severe hyper reflexes in both legs and Hoffman?s sign in both hands. My feet were completely numb and cold to where I couldn?t feel them or walk. Literally felt like everyday I was standing in a ice cold bath with no feeling of touch hot or cold sensation or pin pricks. He realized my loss of sensation was from my bra line down and included tingling in my hands and weakness in my arms. I was able to get up for the first time with a walker and take a few steps with assistance at this time. He then sent me to ER to be admitted and see their neuromuscular team to get further treatment. Upon arrival via wheelchair I was brought back to see the ER Doctor and re-did a neuro exam, some blood work and contacted the neurology team to come see me. I was then admitted to the hospital step down ICU under Dr with strict monitoring. On 2/10/21 The neuro team ordered another set of MRI of brain, cervical and thoracic with and without contrast due to a change in condition again since my last visit to hospital. They reviewed and compared studies with no changes. They scheduled me for MRI lumbar on 2/11/21 with and without contrast which came back no changes from previous MRI as well as another LP which everything that was off before was now normal. Everyday I would work with PT, OT and speech. I had no changes in speech and slowly got some strength back, and was able walk using a walker. I was then discharged home on 2/13 mid afternoon and was told I would do home health and follow up with their neurologist and Neuromusclar team once everything was resulted back. On 2/19/21 I saw my primary doctors office (nurse practitioner) where she checked up on the status of me, took me officially off work and on state disability, filled out paperwork for work and a handicapped pass. On 2/25/21 followed up with neurology, and discussed all my imaging and blood work. All CSF fluid came back normal, all labs were fine and wanted me to get an EMG to look for nerve damage. She also wanted a follow up with cardiology as my resting heart rate was 110-120 and would spike to 160s. On 3/1/21 Home health was started for physical therapy for strengthening and working on sensation for both legs. At this point I had almost full strength in my arms, still tingling in my hands and constant numbness and cold feeling in both feet and knees with severe sensitivity to cold, wind or touch on my legs. I had Home health twice a week every week for 2-3 weeks then started outpatient physical therapy which has been twice a week for 1.5 hours. On 3/5 I saw cardiology and was placed on a holt monitor for 48 hour monitoring. On 3/9 I had my EMG with Dr. and had a follow up with Dr. for 35 tubes of blood he had drawn for multiple diseases which both blood work and EMG came back negative. On 3/16 symptoms started to change from numbness to severe hypersensitivity to touch, severe shooting nerve pains, burning sensations, non stop tingling in hands, issues with temperatures either hot or cold, and swelling of both legs. On 3/17 I saw rheumatology that looked into everything said it was not lupus related as none of my inflammatory markers or lupus DNA strands were elevated and no lupus symptoms like rashes, ulcers in the mouth or tongue, hair loss or joint pain. He ordered more blood work and confirmed it was not a lupus flare up. He suggested doing a small nerve fiber biopsies. On 3/19/21 saw spinal orthopedics who reassured it has nothing to do with my spine, prescribed gabapentin for all the nerve pain and told me that neurology is who should be following me. On 3/26 I had an echocardiogram done due to the leg swelling and heart rates which came back negative for any heart problems and was told since the tachycardia is getting better to just continue watching it and was prescribed trazodone 25mg to help with sleep due to severe nerve pains, spasms and severe back and hip pains at night. On 4/1/21 was followed up again with neurology. Ordered small nerve fiber biopsy for may 18th, increased the gabapentin to 300 mg- 3 times a day and had me wean off cymbalta. I am still dealing with tingling, burning hot and cold sensitivities in both legs, still tingling in hands all day but strength is back to full. I am scheduled to hopefully return to work 5/30/2021 after being off since 1/24/2021.
29 2021-04-17 rash throat has been itching; having a hard time breathing; everything hurts and feels like she got hit b... Read more
throat has been itching; having a hard time breathing; everything hurts and feels like she got hit by a truck; bad allergic reaction; throat started closing up; throat has felt swollen; wheezing; a rash on and off located around her throat and chest.; her symptoms began at the vaccination site; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EP8720), via an unspecified route of administration in left arm on 27Mar2021 11:00 (at the age of 29-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store and vaccine was not administered at military facility. Medical history included asthma and pulmonary embolism, both ongoing. There were no family medical history relevant to the events. No AE(s) following prior vaccinations. No Prior Vaccinations (within 4 weeks). The patient had no investigation assessment. Concomitant medications included apixaban (ELIQUIS) from an unspecified start date and ongoing for pulmonary embolism and prednisone for asthma from 31Jan2021 and ongoing. The patient received the first dose of BNT162B2 on this past Saturday (on 27Mar2021) and she had a bad allergic reaction and she has been having allergic reaction symptoms since then, almost in anaphylactic shock, throat has felt swollen, she has been wheezing, a rash on and off located around her throat and chest and throat started closing up, all on 27Mar2021 at 11:08. The patient stated her symptoms began at the vaccination site and she was taken by ambulance to an emergency room for treatment. On 28Mar2021, another allergic reaction; wheezing and her throat started closing up and she had a rash around her neck. On 31Mar2021, the patient was having allergic reactions, throat has been itching, having a hard time breathing, and everything hurts and feels like she got hit by a truck. The patient had the shot on Saturday 27Mar2021 and within eight minutes she was almost in anaphylactic shock. The patient got that taken care of and the next day she went into another allergic reaction and now today she was still having allergic reactions. The patient considered the events as non-serious. The patient would like to know how long her symptoms would last. Called ambulance with treatments included 2 shots of Epi and IV steroids and diphenhydramine hydrochloride (BENADRYL) and nebulizer treatments. The patient had anaphylactic reactions with allergy shots. The events required emergency room visits on 27Mar2021 and on 28Mar2021. No physician office visit. The outcome was recovered for anaphylactic shock, rash and wheezing on 27Mar2021; unknown for vaccination site reaction and not recovered for the remaining events.
29 2021-05-05 vaccination site redness 4 inches by 4x pustular rash with irregular erythemic borders - location left deltoid at injection s... Read more
4 inches by 4x pustular rash with irregular erythemic borders - location left deltoid at injection site; 4 inches by 4x pustular rash with irregular erythemic borders - location left deltoid at injection site; This is a spontaneous report from a contactable physician. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8737 and expiration date were not reported), via intramuscular route administered in left deltoid on 03Apr2021 at 10:00 (at the age of 29 year old) as single dose for COVID-19 immunization. The patient received the vaccine at public health clinic/administration facility. The patient's medical history included lactose - food sensitivity. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced 4 inches by 4x pustular rash with irregular erythemic borders - location left deltoid at injection site on 03Apr2021 at 16:00. These events result in the physician's office visit/emergency room (ER) visit. It was unknown if the patient received treatment for these events. The outcome of these events was not recovered. No follow-up attempts are needed. No further information is expected.
29 2021-05-06 itchy skin swollen bottom lip; tongue ached; chest pains; itching in mouth after eating; swelling and tingling ... Read more
swollen bottom lip; tongue ached; chest pains; itching in mouth after eating; swelling and tingling tongue; swelling and tingling tongue; tight throat after eating; felt like mucus was in throat; enlarged thyroid; lightheadedness; ocular migraines; throbbing lymph nodes in throat; Discomfort in throat; skin itchy; This is a spontaneous report from a contactable consumer (patient). This 29-year-old female consumer (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot En 6506), on 24Feb2021 at 10:00 AM, in left arm, for COVID-19 immunisation. Medical history included benign thalaseemia, irritable bowel syndrome, ocular migraines, peanuts allergy, tree nuts allergy, penicillin allergy, amoxicillin allergy. Concomitant medications were none (no other medications in two weeks, no other vaccine in four weeks). Covid prior vaccination: no. On 26Feb2021 at 11:00, 48 hours post vaccine, the patient experienced itching in mouth after eating, swelling and tingling tongue, tight throat after eating, felt like mucus was in throat, enlarged thyroid. 2 weeks post vaccine, on an unspecified date in Mar2021, the patient experienced swollen bottom lip, tongue ached, chest pains. 4 weeks post vaccine, on an unspecified date in 2021, the patient experienced lightheadedness, ocular migraines, throbbing lymph nodes in throat. Discomfort in throat and skin itchy were also reported. The events resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. Allergist recommended antihistamines 2x per day. The patient had a negative nasal swab on 28Feb2021. The events had not yet resolved.
30 2021-01-01 bruising Paralyzing back pain Extreme bruising Flu symptoms
30 2021-01-02 itchy skin, hives Become tired after returning home from getting the vaccine. I fell asleep and woke up to large hives... Read more
Become tired after returning home from getting the vaccine. I fell asleep and woke up to large hives on my face. Not much longer and the hives/itching spread down my back and chest. Face became swollen. Benadryl cream was initially attempted, but only briefly subsided the itching and reaction continued spreading. I took oral quick release Benadryl and was able to prevent the reaction from continuing. I had to take a secondary Benadryl dose a few hours later and extreme joint pain accompanied the allergic reaction.
30 2021-01-03 injection site pain, hardening For 2 days after the vaccinations, my left deltoid/ upper arm was sore. Approximately 7-8 days after... Read more
For 2 days after the vaccinations, my left deltoid/ upper arm was sore. Approximately 7-8 days after my vaccination, my left armpit started feeling sore. This has continued to today where I have left armpit swelling and what feels to be a swollen, hardened lymph node in my armpit. It feels like a hardened lump that is not fixed and is tender when I palpate it. On visual inspection, I can tell that my left armpit is more swollen than my right armpit (which is normal). It hurts to have my arm at my side and it hurts to lay on my left side at night when I am sleeping.
30 2021-01-03 rash, hives, rash macular Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red ... Read more
Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red splotches over chest and neck. C/o difficulty swallowing and some GI upset. Began to shake uncontrollably. Initial BP was 149/99 and HR 118. O2 sats at 99%. Administered 25mg of benadryl and monitored patient for approximately 1 hour. After about 30-45 minute, her vitals stabilized at 120/80, Pulse 90, O2 at 100% on room air. D/C'd home at 1:32pm. 24 hours later patient c/o of hives and flushing off and on. Also complained of some GI upset and fatigue. Pt was able to return to work on 1/3/2021.
30 2021-01-03 injection site warmth, injection site pain, injection site tingling, injection site redness, injection site numbness Redness around the injection site,continued muscle pain at the injection site, warmth and numbness a... Read more
Redness around the injection site,continued muscle pain at the injection site, warmth and numbness and tingling locally as well. Temperature taken during our call was 99.9 F. She denies hives, dizziness, face or throat swelling or any other signs of allergic reaction. Initially after having the vaccination, she did have some GI upset that resolved after a couple of days.
30 2021-01-04 vaccination site hardening, vaccination site redness, vaccination site pain I experienced nasal congestion the next morning, and redness, induration and pain on the injection s... Read more
I experienced nasal congestion the next morning, and redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; This is a spontaneous report from a contactable physician. A 30-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 23Dec2020 13:30 at a single dose for covid-19 vaccination. Vaccination was done in the hospital. There were no relevant medical history and no concomitant medications. The patient was not pregnant. The patient experienced nasal congestion the next morning, on 24Dec2020 07:00, and redness, induration and pain on the injection site. The induration and redness was around 1-1.5 inches diameter. The outcome of the events was recovering. There were no treatment involved for the events. This was assessed as non-serious. Information on the lot/batch number has been requested.
30 2021-01-04 vaccination site pain Initially soreness in injection area; body backs with back, hip, and knee pain limiting mobility; bo... Read more
Initially soreness in injection area; body backs with back, hip, and knee pain limiting mobility; body backs with back, hip, and knee pain limiting mobility; limiting mobility; Fatigue; chills; This is a spontaneous report from a contactable Other HCP (patient). A 30-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration in right arm, on 28Dec2020 03:30 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Relevant medical history included COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. The patient experienced Initially soreness in injection area on 29Dec2020 10:30 AM. At 19 hours after vaccination started to experience body backs with back, hip, and knee pain limiting mobility on 29Dec2020 10:30 AM. Fatigue and chills fan at 24 hour mark and are continuing now at 28 hours on 29Dec2020 10:30 AM. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
30 2021-01-04 vaccination site warmth, vaccination site hardening, vaccination site redness Still having pain in right arm a week after injection; Warmth/redness and hardness of injection site... Read more
Still having pain in right arm a week after injection; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 19Dec2020 19:15 at single dose on right arm for COVID-19 immunization in hospital. Medical history was reported as none and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced still having pain in right arm a week after injection, warmth/redness and hardness of injection site from 19Dec2020 19:15. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. The information on the batch number has been requested.
30 2021-01-05 skin discolouration 1215-Noted pt sitting on the floor fanning herself after receiving her COVID vaccine. 1220-Pt ambul... Read more
1215-Noted pt sitting on the floor fanning herself after receiving her COVID vaccine. 1220-Pt ambulates to stretcher for further evaulation of clinic staff, FNP. Patient reported no previous adverse reaction to vaccines, but did note an anaphylactic nut allergy. Pt reported a milder version of the symptoms she is experiencing today after her initial vaccine Dec 17, 2020. Initial HR 64 SPO2 74% room air(employee wearing dark fingernail polish and reporting tingling in her hands) Pt instructed to breath slowly in through nose, out through mouth. 1225 BP 150/95 HR 85 SPO2 99% Pt given some water and crackers and reports eating NO food today other than a few cookies. Pt reports feeling better, color has now returned to pt. 1235- BP systolic 180s. pt advised to be seen in the ED for further evaluation. 1240 patient taken to ED by this RN; FNP; and second RN for further evaluation. 2L SPO2 put on pt en route based on previous low oxygenation. 1245- Pt arrived in ED, pt began reporting blurred vision; handoff to ED staff. Evaluated by ED staff, medicated with 1L NS bolus, 125mg IV Methylprednisone; 20mg IV Famotidine, 50mg IV Benadryl. 1640-employee reported to ED complete resolution of symptoms . Employee discharged from ED with prescription for an Epi-pen and prednisone.
30 2021-01-05 skin discolouration, injection site pain Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until... Read more
Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until about 10am. Uncontrollable tremors, feeling like I need to constantly be moving and tachycardia- started around 830a started to diminish once I took a benadryl around 10a. Headache, fatigue and nausea beginning hours after vaccine, still present on 01/05. Sore arm at injection site and swollen axillary lymph node in same arm.
30 2021-01-05 injection site pain Headache fatigue, pain at injection site, mental fog
30 2021-01-05 itchy skin I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itch... Read more
I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itching but not at the injection site, lower. then my eye started itching a little later. I got scared and went to the UC and they told me to take Benadryl. It was just for a day after I took the Benadryl the next day all was back to normal.
30 2021-01-05 injection site pain Pain in site of injection, malaise, chills, retro orbital pain for approximately 24h.
30 2021-01-05 redness Palpitations, elevated heart rate. Red Face. Red upper chest. Complained of lightheadedness and pre-... Read more
Palpitations, elevated heart rate. Red Face. Red upper chest. Complained of lightheadedness and pre-syncopal. HR radial 120 bpm, BP 145/91 with HR 111 with BP cuff. Able to be released, feeling better. Recheck of BP 137/84, HR 88 bpm.
30 2021-01-05 injection site redness, injection site swelling Redness and swelling at injection site. Soreness like a bruise. Redness started about the side of a ... Read more
Redness and swelling at injection site. Soreness like a bruise. Redness started about the side of a nickel and progressed over the next 6-8 days to the size of a baseball. Localized swelling of that area was noticeable but not alarming. At two weeks the redness had completely resolved leaving just a nickel sized bruise. As of today 1/6/2021, everything has resolved. - Sought out no medical treatment for condition, just monitored at home.
30 2021-01-05 vaccination site pain pain and inflammation of the right axillary nodule; pain and inflammation of the right axillary nodu... Read more
pain and inflammation of the right axillary nodule; pain and inflammation of the right axillary nodule; Pain in the right arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration at the right arm on 28Dec2020 11:00 at a single dose for COVID-19 immunization. Medical history includes chronic migraine and sinusitis. The patient was not pregnant at the time of vaccination. Concomitant medications were amitriptyline and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, the patient experienced pain in the right arm. On 29Dec2020 23:00, approximately 40 hours later the patient experienced pain and inflammation of the right axillary nodule. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
30 2021-01-05 rash rash on face, 30 minutes later
30 2021-01-06 injection site pain Chills and body aches, 30 hours Fever, 8 hours, max 101.7, Tylenol Soreness and injection site, 48 h... Read more
Chills and body aches, 30 hours Fever, 8 hours, max 101.7, Tylenol Soreness and injection site, 48 hours
30 2021-01-06 itchy rash, rash Chills, myalgias, rash to chest and ear that is pruritic (started day after the vaccine and continue... Read more
Chills, myalgias, rash to chest and ear that is pruritic (started day after the vaccine and continued to day 3 post vaccine). No signs of anaphylaxis.
30 2021-01-06 injection site pain For 48 hours following injection, mild to moderate injection site pain was experienced. 5 days after... Read more
For 48 hours following injection, mild to moderate injection site pain was experienced. 5 days after the injection, symptoms including headache, body aches, fatigue lasting 24 hours.
30 2021-01-06 injection site pain, pain of skin Headache back of neck, twmples and eyebrows, really sore injection site. Fatigue, Malase, nausea off... Read more
Headache back of neck, twmples and eyebrows, really sore injection site. Fatigue, Malase, nausea off and on, decreased appetite. Feeling dehydrated, chills/ at times painful sensitive skin similar to the flu. Muscle aches throughout the body.
30 2021-01-06 vaccination site pain Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint ... Read more
Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination. Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
30 2021-01-06 injection site pain Shortly after receiving the vaccine: lightheadedness lasting a few hours. The day after sore arm at ... Read more
Shortly after receiving the vaccine: lightheadedness lasting a few hours. The day after sore arm at the injection site. 3 days after until present: major fatigue.
30 2021-01-06 itchy skin, injection site pain body itchiness on right hand and left upper body. Soreness at the injection site.
30 2021-01-07 hives, redness Allergic reaction, hives, wilts, itching,redness 30 min after taking benadryl
30 2021-01-07 hives, itchy skin Allergic reaction: hives, wilts, redness, itchiness, abdominal pain Treated with Benadryl and went ... Read more
Allergic reaction: hives, wilts, redness, itchiness, abdominal pain Treated with Benadryl and went away in 30 min or so
30 2021-01-07 injection site pain Fatigue, body aches, chills, very sore site extremity all last about 24 hours, rigid neck, headache
30 2021-01-07 vaccination site pain Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous r... Read more
Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), intramuscular on left arm on 18Dec2020 16:30 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included birth control medication (unspecified) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. On 19Dec2020 at 09:00 AM, patient experienced fever, aches, fatigue, injection site soreness for 5 days and loss of appetite. No treatment was received for the reported adverse events. Since the vaccination, the patient has not been tested for Covid-19. The outcome of the events was recovered. Information about lot/batch number has been requested.
30 2021-01-07 injection site warmth, injection site pain Headache, pain and warmth of injection site, and strange dreams
30 2021-01-07 vaccination site pain Mild to moderate injection site soreness 48 hours; This is a spontaneous report from a non-contactab... Read more
Mild to moderate injection site soreness 48 hours; This is a spontaneous report from a non-contactable other hcp. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 30Dec2020 19:30 at single dose for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication included amitriptyline (AMITRIPTYLINE), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient experienced mild to moderate injection site soreness for 48 hours (non-serious) on 30Dec2020 20:00 with outcome of recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained
30 2021-01-07 pain of skin, rash macular Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next ... Read more
Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next morning I had a fever and my joints, muscles, head and even my skin was hurting. My fever never came down to normal even with advil and I was extremely tired all day. The arm that had the injection is extremely sore with splotches of red (which is expected.) Today, 01/08, I woke up in a pool of sweat. My head is still hurting and I still have a fever. My arm is still sore but my skin and joint pain has improved. I am still very cold. Have been wearing my winter coat in my house even with the heat and the fire place on. I had to take the last two days off work.
30 2021-01-07 dry skin, rash papular, rash, rash with redness Pt received first dose of Pfizer COVID vaccine on 12/22/20 on L deltoid. On 12/25/20 Pt began develo... Read more
Pt received first dose of Pfizer COVID vaccine on 12/22/20 on L deltoid. On 12/25/20 Pt began developing a rash on her left elbow. Rash then spread to the bilateral arms and became more concentrated, and scantly on the bilateral lower extremities. She denies any other symptoms. No improvement with hydrocortisone cream. Pt presented to Urgent Care on 12/29/20 for workup. Per provider "On exam there is a concentrated erythematous papular rash that blanches with pressure on the bilateral upper extremities, right greater than left. It coalesces on the right arm as seen in picture below. It does feel rough in texture. No vesicular lesions, bulla, crusting. Few erythematous papular lesions that are scant on the bilateral lower extremities. Rash spares the palm and soles of feet. Exam otherwise unremarkable." Pt treated with 12 mg dexamethasone PO and given prednisone 20 mg BID X 5 days for outpatient prescription. Patient was discharged without further escalation of care.
30 2021-01-07 injection site pain Severe flu like symptoms, fever over 101, chills, body aches, headache, nausea/loss of appetite, fat... Read more
Severe flu like symptoms, fever over 101, chills, body aches, headache, nausea/loss of appetite, fatigue, soreness in the arm from injection
30 2021-01-07 injection site pain Soreness at the site about 3 hours after the injection followed by headache about 24 hours after. Th... Read more
Soreness at the site about 3 hours after the injection followed by headache about 24 hours after. Then about 48 hours after, developed diffuse myalgia and drowsiness
30 2021-01-07 itchy skin, injection site warmth, redness generalized pruritis, left arm swelling, redness, tenderness. significant redness and warmth surroun... Read more
generalized pruritis, left arm swelling, redness, tenderness. significant redness and warmth surrounding site of injection.
30 2021-01-07 vaccination site pain left deltoid was sore; left armpit was sore; It was sore to have left arm on side and it was sore wh... Read more
left deltoid was sore; left armpit was sore; It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest; left armpit is noticeably more swollen than right armpit; swollen, hard, lymph node which is not fixed when I palpate it; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 22Dec2020 at 12:00 at the age of 30 years at single dose for COVID-19 immunisation. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks and she did not receive other medications in two weeks. Relevant medical history included allergy to sulfa based medication. Concomitant medications were none. On 29Dec2020 at 17:00, the patient experienced left deltoid was sore, left armpit was sore, soreness was radiating down her left side and into her left chest, left armpit was noticeably more swollen than right armpit and swollen, hard, lymph node which was not fixed when she palpated it. The patient reported that for 2 days after the vaccination her left deltoid was sore which went away. Then, approximately 7-8 days after the vaccination, she noticed her left armpit was sore. This has persisted and the patient could feel a swollen, hard, lymph node which was not fixed when she palpated it. Her left armpit was noticeably more swollen than her right armpit (which wass normal appearing). It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient did not receive corrective treatments for the reported events. At the time of the report, she had not recovered from the events. The information on the lot/batch number has been requested.
30 2021-01-08 injection site pain 3am woke up freezing cold and shivering. Temp 99.7. 4:30am temp was 101.3. Took 975mg Tylenol. 8:00a... Read more
3am woke up freezing cold and shivering. Temp 99.7. 4:30am temp was 101.3. Took 975mg Tylenol. 8:00am fever broke. Headache. Took more Tylenol 2:00pm headache. Took migraine medication. Laid down to sleep. 5:30pm woke up. Temp 100.7. Took 650mg Tylenol. 8pm fever broke. Headache better. *fatigue and soreness at injection site all day* Saturday 1/9/21 Feeling much better. No fever or headache so far. 11:30am.
30 2021-01-08 injection site pain Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately afte... Read more
Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately after injection. Benadryl was given and EMT advised going to the hospital for observation. Heart rate and bp returned to normal a few hours later. Still feel dizzy and lightheaded when standing. Was informed that it was a vasovagal reaction. Arm is also very sorry at injection sight. Left arm where injection was placed it still tingling in hand, right hand feels normal.
30 2021-01-08 injection site pain, injection site swelling, itchy skin, injection site pruritus severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints a... Read more
severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints and muscles, headache, achy eyes, extreme tiredness, itchy all over and swollen, painful and itchy injection site.
30 2021-01-09 hives, itchy skin Full day on 01/09/21-extremely sore muscles to the point of it being painful to move and breath. Ext... Read more
Full day on 01/09/21-extremely sore muscles to the point of it being painful to move and breath. Extremely painful joints. Felt like there was an ice pick trying to pry them apart. Full day 01/10/21-hives and extremely itchy. Sore, not as bad as first day.
30 2021-01-09 injection site pain Sore and swollen arm at injection site, headache, fatigue, fever, chills
30 2021-01-10 rash, redness At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they wer... Read more
At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they were on fire. The next morning I had chills, severe joint pain, fatigue, dizziness, nausea, and rash/ redness on my face (cheeks, nose, forehead). The next day (Sunday, the 10th) I felt much better but still a bit of joint pain and fatigue. Today (Monday the 11th) I felt fatigued, with. A resting heart rate of 90 according to my fitbit. I had some numbness/tingling in my right arm, dizziness, and felt fatigued. Towards the end of today I felt better but still have some pain in lower back and neck.
30 2021-01-10 itchy skin Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling fa... Read more
Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling faint, lethargy. Was wheeled to ED where they left me in the waiting room for two hours, not seen by a provider, before being told I was "fine" and sent home. On 1/9/2020 I began experiencing widespread bodily itch, no hives or swelling that included in and around my mouth. Took cirtirizine and symptoms were alleviated.
30 2021-01-10 injection site pain Pain at injection site, constant, began ~2 hours after vaccine administration-time of VAERS submissi... Read more
Pain at injection site, constant, began ~2 hours after vaccine administration-time of VAERS submission Chills, duration from 3 AM-5 AM on 1/11/2020 ~14 hours after vaccine administration Generalized muscle aches, constant, began at 6 AM on 1/11/2020 - time of VAERS submission, ~ 17 hours after vaccine administration
30 2021-01-10 injection site pain, injection site swelling Severe head ache; nausea/vomiting; chills; muscle aches; injection site pain and swelling
30 2021-01-10 vaccination site pain Slight pain at the injection site; sore/tender muscles on the left side of the body (mainly shoulder... Read more
Slight pain at the injection site; sore/tender muscles on the left side of the body (mainly shoulder & neck); soreness/stiffness in left hip; soreness/stiffness in left hip; fatigue; This is a spontaneous report from a contactable pharmacist, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1284) solution for injection intramuscular in the left arm on 31Dec2020 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01Jan2021, the patient experienced slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. No treatment was provided for the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. The outcome of the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
30 2021-01-10 hives experiencing an allergic reaction; Hives all over her face and neck/hives on face and neck; This is ... Read more
experiencing an allergic reaction; Hives all over her face and neck/hives on face and neck; This is a spontaneous report from a contactable Physician (patient). A 30-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140, Expiry Date: 31Mar2021) via an unspecified route of administration in left upper arm on 31Dec2020 13:25 at single dose for COVID-19 immunisation. Medical history included crohn's disease from Jul2005 and ongoing, ongoing psoriasis, gastrooesophageal reflux disease (GERD), hand tremor. Concomitant medication included ongoing infliximab (REMICADE) for Crohn's, ongoing esomeprazole sodium (NEXIUM) for GERD, ongoing propranolol for hand tremor, copatsol topical steroid for Psoriasis, ongoing Multivitamin, ongoing vitamin B complex (B COMPLEX), ongoing biotin, ongoing iron, ongoing Calcium/Vitamin D, ongoing curcuma longa (TURMERIC). The patient had an allergic reaction after getting the COVID vaccine. She had an allergic reaction after getting the vaccine. She had hives all over her face and neck. She already had a Medrol Dose Pack at home and some Benadryl. She contacted her doctor who prescribed an Epi Pen for her, but she did not have to use the Epi Pen. She stated she used the Benadryl for three days. She started to get hives all over her face and neck the same date she got the vaccine. It started 2 hours after she got the vaccine (31Dec2020 15:25). She confirmed this was the first dose of the COVID Vaccine. She asked that if it is safe to take the second dose after experiencing an allergic reaction to the first dose. Symptoms include hives on face and neck. Patient had no trouble breathing. Took steroids and Benadryl for 3 days or until symptoms have been managed. No any of the events require a visit to emergency room. Reporter seriousness for hives all over her face and neck was reported as medically significant. Events outcome was recovered on 03Jan2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Allergic reaction and Hives cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-01-10 hives hives- like breaking out on fore head a lot of swelling in face numbness glands swollen under tongue
30 2021-01-10 rash rash on left arm, rash on right arm, rash on left leg. Given diphenhydramine 25mg PO and observed fo... Read more
rash on left arm, rash on right arm, rash on left leg. Given diphenhydramine 25mg PO and observed for 1 hour, no increase in reported symptoms. No difficulty breathing / SOB/ wheeze / anaphylaxis noted.
30 2021-01-11 itchy skin, hives Date of symptom onset ? 1/1/21? Symptoms - ? EE reports she began with abd pain, and itchiness to h... Read more
Date of symptom onset ? 1/1/21? Symptoms - ? EE reports she began with abd pain, and itchiness to head, face and ear that progressed to generalized hives. EE denies any changes in hygiene products and NKDA or food allergies per EE. Last day of work and shift - ? Home remedies? - EE took Benadryl after onset of symptoms and reported resolution of hives approx. 30 mins after medication. EE reports she spoke with her PCP and scheduled for allergy testing today (1/12) at 1:30 PM. Any improvement? ? yes Recommendation? EE asking if she should get her 2nd dose as scheduled tomorrow. EE encouraged to attend her allergy appointment today and to consult with her MD today for recommendations whether or not to receive 2nd dose. EE provided with HR support phone number if she needs to cancel/reschedule her 2nd vaccine appointment after MD recommendations. EE encouraged to call vaccine support line if she has adverse reactions after 2nd vaccine dose. EE verbalized back understanding and denied further questions at this time.
30 2021-01-11 redness On day 12 post vaccine, my bilateral temporal area, bilateral jaw, and bilateral cheeks became painf... Read more
On day 12 post vaccine, my bilateral temporal area, bilateral jaw, and bilateral cheeks became painful, erythematous, edematous, and with palpable nodules where I had Sculptra placed back in April/July 2020. Contacted aesthetic APRN in regards to symptoms. Was advised etiology is likely infection resulting from Covid Vaccine. Was started on PO Clindamycin 300 mg TID x 14 days and Ciprofloxacin (unsure of dosage) x 14 days with follow-up in office at Aesthetic office on 1/16/2021.
30 2021-01-11 injection site pain, injection site redness, injection site swelling, injection site warmth Patient received Pfizer COVID-19 vaccine second dose this morning at 8:50am and at 12:15pm started w... Read more
Patient received Pfizer COVID-19 vaccine second dose this morning at 8:50am and at 12:15pm started with burning sensation in the area of where the vaccine was administered. Soon after, within the hour, the area became erythematous and warm. She reported her whole left arm felt "achy". Patient took ibuprofen 600mg at 1pm as well as iced the area. She was evaluated by writer at 2:15pm. The area was noted to be erythematous, warm, and mildly swollen. The redness was outlined with skin marker and noted to be 15cm wide and 13cm in height. She denied any other symptoms.
30 2021-01-11 redness, hardening Pt. states that left arm is hardened, red, and painful. This started on 1/12/2021. Pt. states that s... Read more
Pt. states that left arm is hardened, red, and painful. This started on 1/12/2021. Pt. states that she took Motrin for this and is not sure if this is helping.
30 2021-01-11 rash She developed a rash a few days after vaccine administration. It started out very small on her trunk... Read more
She developed a rash a few days after vaccine administration. It started out very small on her trunk and over the last few weeks has spread to her arms and legs.
30 2021-01-11 hives Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball lik... Read more
Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball like swelling at peak of swelling beginning Thursday evening through Saturday, inability to raise, hold, grasp or use arm for 2 days after injection, consistent fever for 36 hours/intermittent fever through Saturday, tightness in chest (relieved with inhaler every 2 hours) for 36 hours, tingling and phantom pain along left side of body and face, excessive exhaustion, dizziness and unfocused thoughts 48 hours, persistent migraine for 36 hours, intermittent headaches continuing with chills and nausea. Worse symptoms were 24-72 hours after injection, more mild side-effects (intermittent headache, nausea and chills) continuing through today.
30 2021-01-11 rash, skin swelling, injection site rash severe headache for 72 hours bump beginning under skin 24 hours after injection, small bumps under t... Read more
severe headache for 72 hours bump beginning under skin 24 hours after injection, small bumps under the surface appear 72 hours later, today (1/12) bumps appearing around injection site
30 2021-01-12 injection site mass, injection site pruritus 1/7/21: Sore arm the night of the vaccine. 1/8/21: Woke-up around 4am with chills. Fever of 101.4 ar... Read more
1/7/21: Sore arm the night of the vaccine. 1/8/21: Woke-up around 4am with chills. Fever of 101.4 around 7am with generalized malaise and severe fatigue. Spent most of the day in bed. Fevers on and off throughout the day with Tmax of 101.4. Some mild body aches. Sore arm with itching at the injection site. Lump at injection site. Had to call off of work. Loss of appetite. 1/9/21: Afebrile the whole day. Moderate fatigue in the morning. Overall felt better by the afternoon. Sore arm continued with itching and lump remaining at the injection site. 1/10/21: Overall felt better, arm soreness and itching at injection improving. 1/11/21: Mild fatigue. No arm soreness. Itching improved. Lump at injection site improving. Mild body aches in the evening. 1/12/21: Mild fatigue. 1/13/21: No arm soreness, itching and lump at injection site gone.
30 2021-01-12 hives 11 minutes after vaccine this employee developed a metallic taste in her mouth, tachycardia and hive... Read more
11 minutes after vaccine this employee developed a metallic taste in her mouth, tachycardia and hives on her chest and neck. She reports her heart rate normalized quickly. Before she went to bed, she felt her tongue slightly swell and developed a scratchy throat. She reports the top portion of her throat feeling swollen as well. Benadryl resolved the symptoms.
30 2021-01-12 injection site swelling, injection site pain Beginning 12 hours after vaccine experienced chills, aches, nausea and headache. Also experiencing p... Read more
Beginning 12 hours after vaccine experienced chills, aches, nausea and headache. Also experiencing pain and swelling at injection site.
30 2021-01-12 bruising Brown reddish abnormal bruising of the left hand, top and bottom of forearm. No treatment. No improv... Read more
Brown reddish abnormal bruising of the left hand, top and bottom of forearm. No treatment. No improvement
30 2021-01-12 vaccination site pain Fever for 8 hours, max 101.7; Chills; body aches; Injection site pain; female patient who just got t... Read more
Fever for 8 hours, max 101.7; Chills; body aches; Injection site pain; female patient who just got the COVID vaccine and is currently breastfeeding; female patient who just got the COVID vaccine and is currently breastfeeding; This is a spontaneous report from a contactable nurse (patient). This nurse reported for both mother and baby. This is maternal report. A 30-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: Elt9899; expiration date: not known), via an unspecified route of administration on left arm on 19Dec2020 10:00 at single dose for covid-19 immunization, administered at workplace clinic. Medical history included childbirth in Jul2020 and currently (ongoing) breastfeeding. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included norethindrone (NORETHINDRONE [NORETHISTERONE]) and unspecified prenatal vitamin (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested with covid-19 since the vaccination. On 19Dec2020 10:00, the female patient who just got the COVID vaccine and is currently breastfeeding. On 19Dec2020 18:00, the patient experienced fever for 8 hours, max 101.7; chills and body aches for 30 hours; and injection site pain for 48 hours. The reported events were non-serious. There was no treatment received for the events fever, chills, body aches, and injection site pain. The outcome of the event 'fever' was recovered on 20Dec2020 02:00 (for 8 hours), of event "chills and body aches" was recovered on 21Dec2020 00:00 (for 30 hours), and of event "injection site pain" was recovered on 21Dec2020 18:00 (for 48 hours).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011500 baby case
30 2021-01-12 injection site pain I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the f... Read more
I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the first time so quickly. It shortly progressed to a cold/numb sensation from my deltoid down to my finger tips. This persisted but seemed to transition from more numbness to moderate pain from my left scapula, neck and down to my fingers about 7 hours after the vaccine. I also developed intermittent fasiculations of my forearm muscles on the left arm. This morning I woke up with worsening pain, mild numbness but new weakness in the hand and arm. I have a weak grip and can?t fully grab objects. My wrist flexión and extension are also weak as well as shoulder abduction (I am a neurologist by the way so can?t localize it to any nerve distribution). I?m not weak anywhere else and I only have mild arthralgia and diarrhea systemically.
30 2021-01-12 injection site reaction, injection site pruritus, injection site swelling, injection site redness Initial injection site reaction (swelling and redness) began in 24 hours and resolved after 3 days. ... Read more
Initial injection site reaction (swelling and redness) began in 24 hours and resolved after 3 days. A secondary injection site reaction (redness and itching with minor swelling) began 10 days after injection and was almost resolved by 15 days after injection. Fatigue occurred 12 hours after injection and resolved in 3 days
30 2021-01-12 redness, itchy skin Patient is afebrile,. Has mild erythema on her upper chest where she was itching in her primary con... Read more
Patient is afebrile,. Has mild erythema on her upper chest where she was itching in her primary concern is feeling flushed at this time. Symptoms resolved and patient remained stable. Discharged to home. Medications diphenhydramine (Benadryl) injection 50 mg prednisone (Deltasone) tablet 40 mg Prescription at discharge - Prednisone 20mg take two tabs by mouth one time a day for 4 days.
30 2021-01-12 vaccination site swelling, vaccination site pain, vaccination site itchiness received first dose of bnt162b2 (BNT162B2) on 18Dec2020 07:00 at SINGLE DOSE, second dose on 07Jan20... Read more
received first dose of bnt162b2 (BNT162B2) on 18Dec2020 07:00 at SINGLE DOSE, second dose on 07Jan2021 11:00; injection site pain; swelling, and itching at injection site; itching at injection site; This is a spontaneous report from a contactable Other HCP (patient). The 30-years-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2) unknown on left arm on 18Dec2020 07:00 at SINGLE DOSE, second dose via unknown on left arm on 07Jan2021 11:00 at SINGLE DOSE, both in hospital for covid-19 immunisation. Medical history included n/a. Concomitant medication included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC). The patient did not receive other vaccine in four weeks. No COVID prior or post vaccination. No Known allergies. The patient experienced injection site pain, swelling, and itching at injection site on 07Jan2021 19:00. No treatment received. The outcome of the event Drug use for unapproved schedule was unknown and for the rest events was not recovered. Information about lot/batch number has been requested.
30 2021-01-13 hives, itchy skin At 4:10 I awoke with pruritus and when i looked at my arms and I developed hives on my bilateral fo... Read more
At 4:10 I awoke with pruritus and when i looked at my arms and I developed hives on my bilateral forearms and bilateral hip area. I felt itchy all over. When I stood up, I felt palpitations and started to feel as if I was going to pass out. I sat down and I started to tremor and felt like it was hard to catch my breath. I took an antihistamine and took a puff of albuterol. I felt a lot better. At 10 AM in the morning, the hives have improved but i still feel some pruritus.
30 2021-01-13 rash maculo-papular, rash, injection site rash Blanching maculopapular rash on arms, legs, trunk/back. Started day 4 after vaccine. Blanching rash ... Read more
Blanching maculopapular rash on arms, legs, trunk/back. Started day 4 after vaccine. Blanching rash at site of injection.
30 2021-01-13 vaccination site pain, vaccination site warmth Headache; pain/warmth at injection site; pain/warmth at injection site; nightmares; This is a sponta... Read more
Headache; pain/warmth at injection site; pain/warmth at injection site; nightmares; This is a spontaneous report from a non-contactable other health care professional. A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: lot number: EL0142), via an unspecified route of administration on 07Jan2021 at SINGLE DOSE at right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and Aspirin; and experienced allergies. On 07Jan2021, the patient experienced headache, pain/warmth at injection site, and nightmares. The outcome of the events was recovered. The patient took some ibuprofen as treatment. No follow up attempts are possible. No further information is expected.
30 2021-01-13 itchy skin Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Ra... Read more
Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Rapid Response called and she was brought to ED. At ED, evaluation done, pt stable, felt to be likely anxiety/panic attack as cause of symptoms, and low likelihood of anaphylaxis. Pt was given rx for Epi pen to keep on hand just in case.
30 2021-01-13 rash Joint pain and headaches. Also full body raised bumps (non pruritic, non pustular). Headaches resol... Read more
Joint pain and headaches. Also full body raised bumps (non pruritic, non pustular). Headaches resolved in about 1 week, joint pain and bumps have lasted a couple weeks now.
30 2021-01-13 itchy rash Pruritic rash all over body that started approximately 2 hours after administration, lasted for a fe... Read more
Pruritic rash all over body that started approximately 2 hours after administration, lasted for a few more hours after taking Benadryl and Famotidine.
30 2021-01-13 vaccination site redness, vaccination site itchiness experienced redness and itching at the injection site (localized to the arm).; experienced redness a... Read more
experienced redness and itching at the injection site (localized to the arm).; experienced redness and itching at the injection site (localized to the arm).; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 07Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot /batch and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness and itching at the injection site (localized to the arm) after she received the first dose of the vaccine. She received Benadryl. The reporter was asking if her employee should receive the 2nd dose if she developed a site injection reaction following the first dose and any premedication to give. Outcome of events was unknown. Information on Lot/Batch number has been requested.
30 2021-01-13 hives throat began swelling up; hives; This is a spontaneous report from a contactable other HCP. A 30-yea... Read more
throat began swelling up; hives; This is a spontaneous report from a contactable other HCP. A 30-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from 06Jan2021 to 06Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: PCN. The patient's concomitant medications were not reported. On 06Jan2021, the patient stated that his throat began swelling up and also had breaking out into hives. The patient underwent lab tests and procedures which included nasal swab (COVID test): negative on 19Dec2020. Therapeutic measures were taken as a result of pharyngeal swelling and hives included Benadryl. Outcome of the events was not recovered. Information on the Lot/batch number has been requested.
30 2021-01-14 injection site pain 20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure... Read more
20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure and warmth (coming in waves) up towards my chest, lasting 1-2 seconds and occurring about every 5 minutes . Was able to withstand feeling until it became difficult to breath. Lips and face turned white and blue, fainted. Felt extremely nausea when awake. Called 911. Vitals were normal apart from BP was very high 130/100's. EKG was NSR. Blood sugar taken was normal around 113. After 1 hour of event, I took a shower and drank water. I felt the wave one more time before trying to fall asleep. Then stopped. Woke up fine.
30 2021-01-14 itchy skin, hives Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, ... Read more
Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown unable to locate or read the details) via an unspecified route of administration at Left arm on 23Dec2020 14:15 at single dose covid-19 immunization. Facility type vaccine was Hospital. No known allergies and no other medical history. Concomitant medication included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), colecalciferol (VITAMIN D). No other vaccine in four weeks. The patient experienced itchiness, hives, wilts, abdominal pain on 01Jan2021 23:45. The events resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination and covid was not tested post vaccination. Treatment Benadryl was received for the events. The outcome of the events was recovered in Jan2021. Information about lot/batch number request.
30 2021-01-14 vaccination site pain Mild pain at injection site and runny nose/sneezing day after vaccine; Mild pain at injection site a... Read more
Mild pain at injection site and runny nose/sneezing day after vaccine; Mild pain at injection site and runny nose/sneezing day after vaccine; Mild pain at injection site and runny nose/sneezing day after vaccine; This is a spontaneous report from a contactable pharmacist (patient herself). A 30-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot Ej1685), via an unspecified route of administration in the left arm on 21Dec2020 12:00 at single dose for Covid-19 immunisation. Medical history included allergy to PCN (rash to PCN as a child). No other vaccine in four weeks prior to Covid-19 vaccine. No Covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient experienced mild pain at injection site and runny nose/sneezing day after vaccine (22Dec2020). No treatment was given to the patient. The outcome of events was recovered.
30 2021-01-14 vaccination site pain, vaccination site swelling Myalgia; overwhelming fatigue; injection site pain and swelling; injection site pain and swelling; T... Read more
Myalgia; overwhelming fatigue; injection site pain and swelling; injection site pain and swelling; This is a spontaneous report from a contactable physician, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek4176, via an unspecified route of administration on 08Jan2021 at 08:30 (at the age of 30 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included attention deficit hyperactivity disorder, gastritis, and hiatal hernia all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included spironolactone, ethinylestradiol, norgestimate (SPRINTEC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), and 'dexylan', all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, lot number: Eh9899 on 18Dec2020 at 10:00 AM in the right arm. The vaccine was given at a Public Health Clinic. On 09Jan2021 at 12:00AM, the patient experienced myalgia, overwhelming fatigue, injection site pain and swelling. The patient did not receive treatment for the events. The clinical outcome of myalgia, overwhelming fatigue, injection site pain and swelling was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
30 2021-01-14 pain of skin, hives, itchy skin, skin burning sensation No symptoms following vaccination #1. Vaccination #2 received 1/13/21-no symptoms on 1/13/21. On 1/... Read more
No symptoms following vaccination #1. Vaccination #2 received 1/13/21-no symptoms on 1/13/21. On 1/14/20 pt reports fever 101.6, chills, body/muscle aches. These symptoms improved during day on 1/14/21. Pt reports evening of 1/14/2021 she began feeling like her skin hurt, burning feeling. On 1/15/2021, pt woke to hives across chest, abdomen, axillas, underside of arms and lateral torsos, scalp and posterior neck. Pt reports hives are present in area of painful skin the day prior. Pt reports hive were not initially itchy, but are at time of evaluation. Pt provided with care instructions for urticaria/hives, benadryl & OTC Allergy tablet instructions. She was also provided for s/s to watch-worsening hives, swelling,
30 2021-01-14 injection site pain Pain at the injection site...
30 2021-01-14 hives Pins and needles tingling sensation throughout entire body at 10 minutes. At 20 minutes hives coveri... Read more
Pins and needles tingling sensation throughout entire body at 10 minutes. At 20 minutes hives covering face, chest and arms. Given 50mg Benadryl and 40 mg Pepcid. Symptoms resolved a little over an hour post injections
30 2021-01-14 rash, injection site pain Soreness at the injection site....Small rash on face Went away without treatment
30 2021-01-14 itchy skin, hives, injection site pain, injection site redness Urticarial rash, itching, swelling, pain and redness at injection site
30 2021-01-14 skin burning sensation, itchy skin, redness Wednesday 1/13/2021 I woke up feeling like nauseous, then later in the day I started to get itchy in... Read more
Wednesday 1/13/2021 I woke up feeling like nauseous, then later in the day I started to get itchy in my lower body that was coming and going (I believe I still had some allegra d in my system). On Thursday 01/14/2021 by noon time the itching had become extreme and unbearable all over my body and felt like my skin was crawling/burning, my chest and parts of my arms were really red . I also developed a lump in my throat that kept getting bigger and felt itchy and couldn't stop clearing my throat. Around 3pm I took 10ml of Claritin. The Claritin had not really helped however the redness had gone down a lot and by 4:30 I was miserable. Informed by a provider I work with to go to urgent care. I arrived at urgent care at about 5:10 where I was treated for an allergy reaction. I was given 0.9% sodium chloride IV bolus 500mL, Methylprednisolone sod suc(PF) (SOLU-Medrol) 125mg Intravenous, Famotidine (Pepcid) 20mg/2ml injection 20mg intravenous, diphenhydramine (Benadryl) 50mg/ml injection 25mg intravenous. The itching subsided within 30 minutes, the itchy throat/ lump was still present but was not getting worse and slowly improving. I was discharged home and was told to pick up famotidine 20mg, otc benadryl and prednisone 50mg to take for 5 days. got home a little after 7 and was able to eat dinner, let dog out, shower, rest before going to bed. I did take another 10 ml of Benadryl at 10:30. Woke up without any itchy skin at 5:45 and was able to return to work this morning. I still have a slight itchy throat but it is tolerable. I took allegra d and famotidine this morning. I am holding off on the prednisone because of the immune response to vaccines from steroids. I don't want to lessen the effectiveness of the vaccine.
30 2021-01-14 rash When the patient got sick she got a rash that didn't itch all over her body; Chills; aching; fever; ... Read more
When the patient got sick she got a rash that didn't itch all over her body; Chills; aching; fever; This is a spontaneous report from a contactable other health professional (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 06:45 AM at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was no. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number and expiration date), via an unspecified route of administration on 18Dec2020 06:30 AM at left arm, at single dose for covid-19 immunization. The patient experienced chills, aching and fever 10 hours later at 08Jan2021 18:30. When the patient got sick she got a rash that didn't itch all over her body and it happened 24 hours after the vaccine, on 09Jan2021. No treatment was received for all events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on lot number/batch number was requested.
30 2021-01-14 hives, rash rash/hives on right arm
30 2021-01-15 injection site pain Injection site pain initially (11/11/21). Followed by generalized body aches starting approximately ... Read more
Injection site pain initially (11/11/21). Followed by generalized body aches starting approximately 12 hours later. Significant lymphadenopathy in the left axilla (same arm as injection site), with tenderness, generalized aching, and obvious swelling and fullness to palpation of the left axilla. Body aches were treated with Tylenol and resolved in 24 hours. Lymphadenopathy in the left axilla persisted until 11/17/21, with improvements in severity of ache and size of swelling noted on 11/16/21.
30 2021-01-15 hives, rash Within 3 hours I developed hives and a rash all over my body and legs and arms. I have no history of... Read more
Within 3 hours I developed hives and a rash all over my body and legs and arms. I have no history of this type of reaction. I took 50 mg of Benadryl which caused the rash to go away.
30 2021-01-16 pain of skin, skin warm, redness, injection site pain 3pm 1/13: sore left arm at injection site 9am 1/15: swollen lymph nodes in left armpit and a raised,... Read more
3pm 1/13: sore left arm at injection site 9am 1/15: swollen lymph nodes in left armpit and a raised, red, hot, painful patch of skin on left arm about 2 inches below injection site
30 2021-01-16 injection site redness, injection site pain, injection site mass Migraine Body aches Large red painful lump at injection site Exhaustion
30 2021-01-17 skin spots, rash with redness, rash Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started t... Read more
Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started to bleed; Humongous scar on her nose; In her hand there's a rash with different dots/red; She has petechiae/rash on the forearm; hit her face; knocked out, hit her nose; This is a spontaneous report from a contactable physician. This physician reported that a 30-year-old female patient (daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blacked out, fainted, felt very unwell, nauseous, chills, fell, knocked out, hit her nose, started to bleed, humongous scar on her nose, in her hand there's a rash with different dots/red, she has petechiae/rash on the forearm, all on an unspecified date in Jan2021. The Caller wanted information on side effects specifically looking at platelet or clotting or bleeding issues. Her daughter, (female, age 29 date of birth) received the 2nd dose of Pfizer vaccine, received it at the (State name), last night. She felt very unwell, nauseous, chills, and then blacked out, fell, knocked out, hit her nose, started to bleed; fainted and hit her face, didn't stop bleeding for 2 hours. There's a humongous scar on her nose. It took 2 hours to stop bleeding. She's going to urgent care today. Her daughter was healthy, yesterday was 2nd dose. In her hand, there's a rash with different dots/red. She has petechiae/rash on the forearm. Thankfully it (bleeding) did stop. The outcome of events for 'knocked out, hit her nose, started to bleed' was resolved on an unspecified date, for other events was unknown. The case was reported as non-serious. Information on the Batch/Lot number has been requested.; Sender's Comments: Based solely on a chronological association a causal relationship between events blacked out and fainted and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-01-17 injection site pain, injection site reaction fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site a... Read more
fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; Started having chills; Severe headache; collapsed on the way back to bathroom and was unable to get up for about 20 minutes; tachycardia; extremely fatigued entire day; This is a spontaneous report from a contactable Pharmacist who reported for herself. A 30-year-old female patient received her second dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number Ej1685) at a single dose at 09:45 AM 07Jan2021 at left arm for Covid-19 immunization in a hospital. The patient had her first dose of Pifzer Covid-19 vaccine on 21Dec2020 at 12:00 PM at left arm, and experienced very mild reactions which included mild pain at injection site and runny nose/sneezing day after vaccine. The paitent had a medical hisotry of rash to penicillin as a child. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to her first dose of Pfizer COVID vaccine. In the evening of second vaccine (around 17:00), pain and stiffness radiated from injection site all the way down arm, into breast, and middle of back. She started having chills. Around 10 hours after dose chills became somewhat violent despite being under 4 blankets. Severe headache also started. In the middle of the night to go to bathroom, she collapsed on the way back and was unable to get up for about 20 minutes. She also suffered from tachycardia overnight. her baseline heart rate runs in 60s- 70s, but was in 110s-120s (based on Apple Watch monitoring). Day after vaccine, she was extremely fatigue entire day and spent all but a few hours in bed. Arm pain mostly gone. Headache was very strong and persistent through the day. On second night chills not as bad but still occurred overnight. HR still elevated in 80s overnight. Morning of day 2 still had headache and fatigue. The patient did not receive any treatment for the events. The outcome of collapse and unable to get up for 20minutes, pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back was resolved, chills and tachycardia was resolving, headache, fatigue was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered that the events was non-serious.; Sender's Comments: Based on a chronological temporal association and known BNT162B2 vaccine safety profile, causality between events fainting, violent chills and severe headache and BNT162B2 ((Pfizer/ BioNTech Covid-19 vaccine) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-01-17 injection site pain injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering to... Read more
injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering took 1 Tylenol at 2:15 am. woke up at 3:23 am to bout of SVT 154 and tachycardia for a few hours after.
30 2021-01-18 vaccination site pain Chills; fatigue; generalized muscle pain; back pain; pain in the arm injected; This is a spontaneous... Read more
Chills; fatigue; generalized muscle pain; back pain; pain in the arm injected; This is a spontaneous report from a non-contactable nurse. A 30-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number: EK9321), intramuscular om the right arm, on 04Jan2021 at 16:00, single dose for COVID-19 vaccination. Medical history included allergies to mango and swiss chard. Patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient experienced chills, fatigue, generalized muscle pain, back pain, pain in the arm injected from 05Jan2021 at 01:00. Facility where the most recent COVID-19 vaccine was administered was in a hospital. No treatment was reported for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021. No follow-up attempts are possible. No further information is expected.
30 2021-01-18 injection site swelling, injection site redness Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
30 2021-01-18 itchy skin, rash Within 5 mins of injection tingling between shoulder blades and face, came in waves. Within 20 mins... Read more
Within 5 mins of injection tingling between shoulder blades and face, came in waves. Within 20 mins of the injection throat tightness, dysphagia. 50mg Benadryl PO, 20mg Pepcid PO, 2 puffs of Albuterol. Throat tightness resolved within the following 30 mins. The next day body aches, itching of arms, and swelling in the left axilla (same side as injection). 48 hours after injection rash and itching on the upper back, chest, and both arms resolved with 50mg Benadryl.
30 2021-01-19 rash macular 30yo female with no documented allergies received COVID-19 Pfizer BioNTech vaccination, dose#1. Pat... Read more
30yo female with no documented allergies received COVID-19 Pfizer BioNTech vaccination, dose#1. Patient c/o feeling warm, blotchy across her face and chest. Stated she was really nervous about receiving the vaccine. Monitored for 45 minutes under direct observation of clinic staff. Initial SBP 156 and decreased to 120/80s. Denies nausea, drinking water. Remained on 100% RA. Blotches appear less bright. Asked to go back to work. No dizziness, ambulated to door without problems. Discharged to self and returned to work.
30 2021-01-19 injection site pain DAY OF VACCINE: SORENESS AT INJECTION SITE MORNING AFTER VACCINE (1/12): BODY ACHES, CHILLS, MILD HE... Read more
DAY OF VACCINE: SORENESS AT INJECTION SITE MORNING AFTER VACCINE (1/12): BODY ACHES, CHILLS, MILD HEADACHE, FATIGUE, INTENSE SORENESS AT INJECTION SITE/ AFTERNOON & NIGHT (1/12): MORE FATIGUE AND SOME NAUSEA. 2ND MORNING AFTER VACCINE (1/13): SOME FATIGUE AND LIGHT NAUSEA. 2ND AFTERNOON AFTER VACCINE (1/13): NO SYMPTOMS. TOOK TYLENOL (EXTRA STRENGTH) & ADVIL.
30 2021-01-19 injection site pruritus, injection site redness, injection site pain, injection site swelling Local allergic reaction with redness pain itching swelling and burning for over 24 hours at site of ... Read more
Local allergic reaction with redness pain itching swelling and burning for over 24 hours at site of injection as time progressed reaction has grown larger to about 2 inches diameter
30 2021-01-20 redness Fever of 99.5; Body aches; chills; red face; feeling flushed 5 hours after 1st shot; Headache for ne... Read more
Fever of 99.5; Body aches; chills; red face; feeling flushed 5 hours after 1st shot; Headache for next two days; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on 15Dec2020 10:00 at single dose (Left arm) for COVID-19 immunization. Medical history included Covid 19. Patient is not pregnant. Patient had no known allergies. Concomitant medication included pseudoephedrine. Facility type vaccine: Hospital. There was no other vaccine in four weeks. On 15Dec2020 15:00, it was reported that patient had Fever of 99.5, body aches, chills, red face, and feeling flushed (5 hours after 1st shot). Temp increased to 100.6 so I took Aleve and I felt better in 30 min. Headache for next two days. After second shot, fever of 99.6 and body aches with chills after 12 hours. Took Aleve and fever was gone felt fine by noon next day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 18Dec2020. Therapeutic measures were taken as a result of fever of 99.5. The outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.
30 2021-01-20 hives Hives on stomach
30 2021-01-20 pain of skin, shingles Rash on her right forearm consisting of clusters of vesicles on an erythematous base; rash is consis... Read more
Rash on her right forearm consisting of clusters of vesicles on an erythematous base; rash is consistent with a diagnosis of herpes zoster or shingles; Radiating burning pain down the underside or volar side of her right arm to her wrist; first felt like a bruise; Radiating burning pain down the underside or volar side of her right arm to her wrist; first felt like a bruise; Pain then began to feel more like a bad sunburn with her skin being tender in the same distribution; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in right arm, on 04Jan2021 at 18:15, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was her workplace clinic. On 05Jan2021 at 03:00 PM, the patient developed radiating burning pain down the underside or volar side of her right arm to her wrist (vaccinated arm) that at first felt like a bruise within 24 hours of receiving the vaccine. In Jan2021, the pain then began to feel more like a bad sunburn with her skin being tender in the same distribution. Then on 11Jan2021, the patient developed a rash on her right forearm consisting of clusters of vesicles on an erythematous base. The patient consulted with a dermatologist in her primary care physician who agreed that the rash is consistent with a diagnosis of herpes zoster or shingles. This resulted in doctor or other healthcare professional office or clinic visit. Treatment received for shingles included valacyclovir. Post-vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
30 2021-01-20 injection site pain Severe body aches especially neck and back pain, nausea/vomiting, severe headache unrelieved by over... Read more
Severe body aches especially neck and back pain, nausea/vomiting, severe headache unrelieved by over-the-counter medication, light sensitivity, fatigue, severe injection-site pain, chills with low-grade fever (99.8F). Symptoms listed began approximately 18 hours after 2nd COVID-19 vaccine was given and lasted until 48 hours after vaccine was administered.
30 2021-01-20 injection site swelling, injection site redness, injection site pain, injection site rash Swelling, pain and red rash around injection site, about size of baseball; Swelling, pain and red ra... Read more
Swelling, pain and red rash around injection site, about size of baseball; Swelling, pain and red rash around injection site, about size of baseball; Swelling, pain and red rash around injection site, about size of baseball; Swelling, pain and red rash around injection site, about size of baseball; dose 2 administration date=07Jan2021/ dose 1administration date=18Dec2020; This is a spontaneous report from a contactable healthcare professional (patient) reported for herself that a 30-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231) via an unspecified route of administration at right arm, on 07Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history was none. Patient did not have COVID prior vaccination. Patient has no known allergies. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number: EH9899) on 18Dec2020 15:00 at left arm for COVID-19 immunisation at the age of 30 years old. The patient experienced swelling, pain and red rash around injection site, about size of baseball on 07Jan2021 16:00. No treatment received for events. Patient did not test COVID post vaccination. Patient did not receive other vaccine in four weeks. Outcome of swelling, pain and red rash around injection site, about size of baseball was recovering, outcome of other event was unknown.
30 2021-01-20 rash, itchy rash, rash papular Two days after receiving my 2nd dose, I began noticing a rash on my stomach that initially appeared ... Read more
Two days after receiving my 2nd dose, I began noticing a rash on my stomach that initially appeared like hives. The rash then turned into small red bumps all over my back and stomach the next day. It is one week later and the rash is still extensive (now on armpits, neck and mild on legs). It itches slightly but not bad. I have tried hydrocortisone cream and Benadryl without much benefit.
30 2021-01-21 itchy skin 1 hour after receipt of booster vaccine, developed pruritis and difficulty breathing, throat tightne... Read more
1 hour after receipt of booster vaccine, developed pruritis and difficulty breathing, throat tightness; Stridor evident in the ED, hypotension requiring epinephrine injections and eventual infusion.
30 2021-01-21 rash 30 yr old getting vaccinated as an employee of hospital. Within minutes of vaccination, developed t... Read more
30 yr old getting vaccinated as an employee of hospital. Within minutes of vaccination, developed tingling in mouth, swelling of tongue, rash on arms and chest (rest of body not examined in room). GIven epi and brought to ER. BP within normal range, exact number not available. In ER given Benadryl and Pepcid, other medications not recollected. Admitted for observation into hospital for one night, discharged next day and doing well.
30 2021-01-21 hives Hives covering entire body for 3 days
30 2021-01-22 injection site pain Burning of arm at time of injection, pain at injection site starting 3 hours post injection and last... Read more
Burning of arm at time of injection, pain at injection site starting 3 hours post injection and lasting for 3 days, fatigue for 3 days, chills/fever for 3 days, myalgia for 3 days.
30 2021-01-22 hives Reaction noted with Dose #2: Hives s/p COVID vaccine at 1100. Pt noted w/ hives on forehead. Denies ... Read more
Reaction noted with Dose #2: Hives s/p COVID vaccine at 1100. Pt noted w/ hives on forehead. Denies difficulty breathing or swallowing at this time. Took 50mg of benadryl PTA. Pt reports mild improvement of symptoms after benadryl and prednisone. Skin signs remain unchanged.
30 2021-01-23 injection site pruritus, injection site redness, injection site rash, injection site warmth Location site is itchy, red rash, warm to the touch.
30 2021-01-23 injection site pain On the evening and day following receiving the second dose of the Pfizer vaccine, I experienced chil... Read more
On the evening and day following receiving the second dose of the Pfizer vaccine, I experienced chills, body muscle aches, headache, and fever (99.7-100.2 degrees). I was unable to get out of bed or go to work. I took ibuprofen at first, for my muscle pain but was told I should instead take Tylenol to reduce my fever and address my pain. My fever and chills recurred last night at about 8pm and I took more Tylenol. Today, I am still experiencing some pain in my arm (injection site) and some chills/dizziness, but am taking Tylenol and have not experienced any recurring fever since last night. I am continuing to drink a lot of fluid and take a low dose of Tylenol at regular intervals.
30 2021-01-24 injection site pain Injection was given and burned on insertion. That evening and proceeding into next day I experience... Read more
Injection was given and burned on insertion. That evening and proceeding into next day I experienced loss of Range of motion in Left upper extremity, pain up to neck and down left arm, and back behind shoulder blade.
30 2021-01-24 injection site pain pain at site, fatigue , chills and headache
30 2021-01-25 pain of skin Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 min... Read more
Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 minutes every 30 minute or so) Tingling in my hands and finger tips.
30 2021-01-25 rash with redness Patient c/o metallic taste, chest tightness, SOB, difficulty breathing, and difficulty swallowing. A... Read more
Patient c/o metallic taste, chest tightness, SOB, difficulty breathing, and difficulty swallowing. Also had a mild erythematous rash. Symptoms began < 5 minutes after vaccination. Epi Pen was administered and code team took patient to the emergency room. In the emergency room the patient was treated with benadryl (50mg PO once), prednisone (60mg PO once), famotidine (20mg PO once)and monitored for 4 hours. Symptoms improved and patient was discharged home safely.
30 2021-01-25 rash Three days after receiving my second dose of the Covid vaccine I started to notice a rash on my fore... Read more
Three days after receiving my second dose of the Covid vaccine I started to notice a rash on my forearms. This rash progressed to all over my stomach/chest/back. I went and saw a dermatologist 8 days after getting the vaccine and they diagnosed me with pityriasis rosea. This can take 6?8 weeks to go away.
30 2021-01-26 injection site discolouration About 2 hours after injection noticed white ring about quarter sized encircling injection site. Sin... Read more
About 2 hours after injection noticed white ring about quarter sized encircling injection site. Since that time hypo-pigmented region has not changed and color has not returned to that part of my arm. A white ring remains at injection site.
30 2021-01-26 injection site pain At the time of vaccination, a part of the liquid contained in the syringe spilled prior to it being ... Read more
At the time of vaccination, a part of the liquid contained in the syringe spilled prior to it being injected. Unclear how much of the dose truly administered. I felt minimal left deltoid injection site pain with the second vaccine than the first.
30 2021-01-26 hives Hives, left arm swelling
30 2021-01-26 injection site pain, injection site warmth, injection site swelling, injection site redness Injection site swelling within 45 mins of injection. Swelling is red, painful, and warm to touch. 4... Read more
Injection site swelling within 45 mins of injection. Swelling is red, painful, and warm to touch. 43 hours hours later swelling is about 2 inches wide and 1.5 inches in height, still red, warm, hard, and painful.
30 2021-01-26 hives Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and bo... Read more
Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and body still hurt; Felt sick; Broke out in hives all over my body; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain under my right breast/body still hurt; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 12Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included the patient had known allergies to Erythromycin and pineapple. The patient had Covid-19 prior vaccination on an unspecified date. The patient had other concomitant medications. On 12Jan2021 14:00, 1 hour after vaccine the patient broke out in hives all over her body. The patient went to the ER at around 2-3pm. Later that night the patient had extreme pain in her right arm, upper right side of her back and under her right breast. The patient called ER and they told the patient to monitor it. The next morning on 13Jan2021 the patient was exhausted, had a headache and felt sick. Her right arm was painful to touch or lay on. The hives went down some. On 14Jan2021 the patient woke at 7am and her lymph node in her right armpit was swollen. It's painful to lower her arm due to the swelling. The patient was still tired and now the patient had diarrhea (on 14Jan2021). The patient's hives were less noticeable today. Her head and body still hurt. The patient had been on bed rest. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects in Jan2021. Information on the lot/batch number has been requested.
30 2021-01-26 hives Patient experienced a mild reaction with first Covid vaccine and upon second vaccine administration,... Read more
Patient experienced a mild reaction with first Covid vaccine and upon second vaccine administration, patient experienced numbness in ear and jaw, hives, nausea, dizziness, and tachycardic. Patient was seen in the emergency department given diphenhydramine 50 mg, famotidine 20 mg, ondansetron 4 mg, and 1L of sodium chloride. Patient was monitored, EKG normal, and then discharged.
30 2021-01-27 itchy skin, rash Besides the typical fever, chills, headache and arm soreness on day 1 and 2, I developed a rash and ... Read more
Besides the typical fever, chills, headache and arm soreness on day 1 and 2, I developed a rash and a feeling of pins and needles throughout my body (except my face) (on Day 2 post vaccine administration). Urgent care on day 3- prescribed loratidine 2x a day and prednisone 1x a day. Day 7- very mild itching.
30 2021-01-27 hives Hives on face, slightly short of breath, anxious. Had taken 50 mg Benadryl OTC before going to Urgen... Read more
Hives on face, slightly short of breath, anxious. Had taken 50 mg Benadryl OTC before going to Urgent Care, reported feeling better once there. Denied wheezing or any other symptoms. Prescribed 20 mg Prednisone, two per day for 3 days to take if needed but no indication of needed
30 2021-01-27 injection site pain I did not feel the shot going in, so much so that I wished I had looked to see if I was actually vac... Read more
I did not feel the shot going in, so much so that I wished I had looked to see if I was actually vaccinated. About 6 hrs after vaccine, I felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine, my arm was so sore I could not lift it. That night I took two Tylenol and had to wrap my arm in a heating pad. I woke up around 3am that following morning with a fever of 104 F. I was so dizzy from the high fever. I felt extremely nauseated. My body ached mostly in my legs and lower back. It hurt to sit on the toilet, to put on clothes. My Fevers happened at night time ranging from 102-104F for 4 days. My injection site soreness lasted for 7 days. Body aches lasted around 2-3 days. Dizziness subsided after my fever broke, but was replaced with a severe headache lasting 2 days.
30 2021-01-27 itchy skin Initial itching around the collarbone progressing up the neck. while in route to ED she started comp... Read more
Initial itching around the collarbone progressing up the neck. while in route to ED she started complaining of a scratchy throat. Seen in ED. no further information provided
30 2021-01-27 injection site swelling Symptoms Fever 100.4 chills, cough, Fatigue swelling at injection site severe fatigue and severe Ma... Read more
Symptoms Fever 100.4 chills, cough, Fatigue swelling at injection site severe fatigue and severe Malaise
30 2021-01-27 rash with redness, rash, rash macular WHEN THE 15 MINUTE OBSERVATION PERIOD ENDED, PATIENT NOTED SCATTERED BLOTCHY RED RASH ACROSS HER UPP... Read more
WHEN THE 15 MINUTE OBSERVATION PERIOD ENDED, PATIENT NOTED SCATTERED BLOTCHY RED RASH ACROSS HER UPPER CHEST/FRONT SHOULDER AREA. RASH ALSO NOTED OVER L SCAPULAR AREA. SKIN IS CLEAR ON THE REMAINDER OF BACK, ADBOMEN, EXTREMITES, BLOTCHES ARE NOT RAISED OR PRURITIC. FACE FLUSHED. PATIENT STATES SHE GETS THIS RASH WHEN SHE IS ANXIOUS. NO DIFFICULTY BREATHING, NO TIGHTNESS IN THROAT OR CHEST, NO NUMBNESS,SWELLING OR TINGLING OF LIPS/TONGUE. PATIENT REMOVED JACKET LAYERS OF CLOTHING AND MASK, GIVEN WATER AND CRAKERS (ALSO HAD NOT EATEN FOR SEVERAL HOURS). LUNGS ARE CLEAR TO AUSCAULTATION. BP 130/91, PULSE OX 100%, PULSE 93. RASH BEGAN TO SUBSIDE ABOUT 5-10 MINUTES AFTER PATIENT FIRST NOTED IT, AND WAS COMPLETELY GONE WITHIN 20-30 MINUTES. PATIENT STATED SHE FELT WELL, HAD NO FURTHER COMPLAINTS.
30 2021-01-27 itchy rash, rash itchy rash - hips , thighs after vaccine #1 12-23-20 rash developed on 1/8/20 had vaccine #2 - 1/13... Read more
itchy rash - hips , thighs after vaccine #1 12-23-20 rash developed on 1/8/20 had vaccine #2 - 1/13/21 - rash progressed to include upper back, elbows, axilla
30 2021-01-28 injection site pain I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredn... Read more
I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hour mark I started having a heartbeat 15-20 bpm higher than my normal, chest tightness, difficulty breathing, and dizziness. I'm now 3.5 days post vaccine dose 1 and still having all of the symptoms in my last sentence plus extreme exhaustion, muscle pain, and fever.
30 2021-01-28 hives This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old fem... Read more
This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) solution for injection, intramuscular on right arm 14Jan2021 12:30 at a single dose for Covid-19 immunization. Medical history included chronic sinusitis due to allergies, asthma; allergies to corn, wheat, Penicillin, Sulfa, and cephalosporins. The patient was not pregnant. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (AUROVELA FE 1/20), and salbutamol (ALBUTEROL HFA). The patient experienced hives - full body on 14Jan2021 17:00 (as reported), experienced it approximately 4-6 hours after receiving vaccine. It was resolved with Benadryl. Patient stated that to be fair, she has a lot of allergies and she does occasionally experience full body hives on days when she has not received a vaccine or changed her diet/detergents. Patient did not have COVID prior vaccination. Patient has not been tested for COVID-19 after receiving the vaccine. Outcome of the events was recovered. No follow-up activities are needed. No further information is expected.
30 2021-01-29 injection site pain, injection site swelling Aches, severe headache, fever over 101.1, loss of appetite, overall malaise, injection site swelling... Read more
Aches, severe headache, fever over 101.1, loss of appetite, overall malaise, injection site swelling and pain for four days
30 2021-01-30 shingles, injection site pain Burning sensation entire arm of injection site - started roughly four hours after injection. Extreme... Read more
Burning sensation entire arm of injection site - started roughly four hours after injection. Extremely nauseous for several days. Strong headache and fatigue. Shingles outbreak a week later on the same side as injection, lower left leg.
30 2021-01-30 injection site pain Injection site pain, muscle and body aches, chills and fever up to 101
30 2021-01-30 skin peeling The day after the first dose I began experiencing pre-menstrual symptoms including heavy cramping. I... Read more
The day after the first dose I began experiencing pre-menstrual symptoms including heavy cramping. I also began shedding from my vagina small clumps of skin, maybe the size of a pea. I started my period about a week later and experienced much heavier flow than normal in a much shorter period of time. My second dose was received on 01/20/21 at 10am at the same facility. The day after I began similar feelings of cramping and experienced very heavy, opaque white discharge from my vagina with a couple of pea sized clumps of what looked like my vaginal wall the day or two after, but then none at all. I continued to see this odd discharge until today (01/31/21). Neither experience was at all painful, but it was very alarming.
30 2021-01-31 injection site pain 12 hours post-injection patient experienced fever (100 degrees F), headache, lethargy, significant p... Read more
12 hours post-injection patient experienced fever (100 degrees F), headache, lethargy, significant pain at injection site, chills, aching joints, and painful swollen lymph nodes in the armpit of the arm the injections was administered in. Symptoms resolved by about 36 hours post-injection. Only remaining symptom at 4 days post-injection is swollen lymph nodes, no longer painful.
30 2021-01-31 injection site pain, injection site swelling Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Other- hand ... Read more
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Other- hand on same side as injection is very swollen - dbl in size-Medium; symptoms lasted 1 day
30 2021-01-31 injection site pain, injection site pruritus, injection site redness Sore and itchy at site of vaccination; Redness 1" diameter around site of vaccination.
30 2021-01-31 skin warm, redness Warm , red area, and swollen.
30 2021-02-01 injection site bleeding I received the Pfizer vaccine on January 11th, 2021. On January 12th,2021 I experienced nausea, seve... Read more
I received the Pfizer vaccine on January 11th, 2021. On January 12th,2021 I experienced nausea, severe body aches, chills, sweating, a severe headache and fatigue. Symptoms lasted about 24 hours. I had some axillary tenderness (I had this with the first vaccine as well) this lasted about a week. I also had some moderate bleeding at injection site after the vaccine was given. it resolved quickly. I took Tylenol and ibuprofen for the headache and body aches.
30 2021-02-01 rash, hives My first reaction after the second dose of Pfizer vaccine was numb right arm immediately after the i... Read more
My first reaction after the second dose of Pfizer vaccine was numb right arm immediately after the injection. This was followed by a feeling of shakiness and cold sweating. After about 20 minutes my heart started racing and hives/rash on neck and chest. After about 30 minutes of observation I was told to go straight to urgent care. I went to Accelerated Urgent Care. I received a shot of I believe Dexamethasone and was prescribed prednisone. Throughout the weekend following the injection on Friday I have felt tired and have had moderate diarrhea and feelings of being flushed.
30 2021-02-01 injection site pain On the next day of the vaccine on 1/13/2021 I woke up around midnight because I felt feverish, achy,... Read more
On the next day of the vaccine on 1/13/2021 I woke up around midnight because I felt feverish, achy, & chills. Also had pain in the injection site. The fever feeling lasted about an hour or 2 but the aching lasted for about 12 hrs.
30 2021-02-01 injection site pain Pain and soreness at the injection site which started approx 4 hours after vaccine and lasted approx... Read more
Pain and soreness at the injection site which started approx 4 hours after vaccine and lasted approx 72 hours. Malaise and fatigue that started approx 4 hours after vaccine and lasted for 48 hours. Headache that started approx 4 hours after vaccine and has lingered one week later; as of reporting headache has not resolved.
30 2021-02-01 redness Received 1st dose Pfizer COVID vaccine at 8:36am. At 9:43 am patient complained of chest tightness ... Read more
Received 1st dose Pfizer COVID vaccine at 8:36am. At 9:43 am patient complained of chest tightness and shortness of breath. Facial redness and tension. Complained of facial tingling and cheeks feeling "tingly". Administered 1 epi-pen to right thigh at9:00am. Continued to complain of chest pain, throat tightness, and facial tingling and numbness. Administered 2nd epi-pen at9:04am and 911 called. Patient transported to ER.
30 2021-02-01 injection site swelling, injection site redness, injection site pruritus Redness, slight swelling, and itchiness at injection site.
30 2021-02-03 redness Five to ten minutes after the vaccine I got red, head itched/sweaty and face was tingly as well as h... Read more
Five to ten minutes after the vaccine I got red, head itched/sweaty and face was tingly as well as hands. My heart rate went up to 186 I became Tachycardia. I t came in all of a sudden. I ended up going to the E. They gave me IV fluids, Benadryl thru the IV. They also did a CT scan on my brain. After three hours they discharged me . I felt Tachycardia for about two days after. After the 2-3 day I felt better. I had another Tachycardia episode on January 25,2021- I was scheduled to get my second dose but didn't get it done. It just hit me and my heart rate went up, it has not gone away and have been dealing with it for about two weeks. I have a heart monitor on me. I saw a Gastrologist and they want to do an EGD to rule out ulcers. I'm not able to eat without feeling a hot rush and my heart rate going up. I have lost 12lbs since the 20th.
30 2021-02-03 injection site pain Pfizer-BioNTech. I suffered from chills, headache, joint and muscle aches, and nausea. The symptoms ... Read more
Pfizer-BioNTech. I suffered from chills, headache, joint and muscle aches, and nausea. The symptoms were severe from 7:30 pm on Monday, the day of the dose (vaccine received at 9:30AM), until 5:30 PM Tuesday (approximately 22 hours). The symptoms were relieved by taking extra strength tylenol every 4 hours. The symptoms were lessened, but still present until 9:30 AM on Wednesday. I was still suffering from a minor headache all day Thursday. I also had soreness in the injection site, there was no swelling or redness that I noticed; the soreness was mostly gone by Thursday. I have had a left eyelid twitch in the past (randomly), it returned after the vaccine and was very bothersome. Today is Thursday and the eyelid twitch is still bothering me.
30 2021-02-03 itchy skin anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting fo... Read more
anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting for herself. A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis . Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy , food allergy , contrast media allergy (gadolinium). There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8 on 13Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included allergy test: unknown results on Jan2021 , body temperature: 100.8 on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day. The patient also received Decadron and Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions. Follow up information has been requested.
30 2021-02-04 hives Hives on arm
30 2021-02-04 skin discolouration Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following ... Read more
Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: burning form the inside out some dizziness Lot: EN9581 Time of Administration: 14:37 Time Symptoms Began: _____ Patient alerted observer who took the patient to the medical observation area. I was alerted and responded. Initial Assessment @ _2:44p_: Patient is AAO. The employee is sitting up on the sofa. The employee is pink and does not appear to be in distress. They are talking and making conversation. Vitals @: 2:44pm HR: 98 BP: 163 / 95 - BP is usually 100/70ish O2: 99 Vitals @: 2:46pm HR: 84 BP: O2: 98 Vitals @: 2:49pm HR: 65 BP: 135/96 O2: 99% Patient is feeling much better. She no longer feels hot. Discharged at 2:52pm
30 2021-02-05 rash Patient presented to COVID-19 Vaccine clinic on 02/06/21. Reported listed allergies (see nots above)... Read more
Patient presented to COVID-19 Vaccine clinic on 02/06/21. Reported listed allergies (see nots above) and pharmacist noted throat swelling and shortness of breath for reaction. Patient received 1st dose of Pfizer COVID-19 Vaccine and reacted to administration. Patient experienced lip swelling, which triggered pharmacy staff to follow Albertson's/Acme Markets Vaccine Emergency Protocol - Patient took diphenhydramine 25mg by mouth. Reaction continued and a rash developed, which spread from her lower extremities and covered her stomach. Patient took another diphenhydramine 25mg by mouth. An ambulance was called and arrived at clinic. At that time, she reported feeling better due to diphenhydramine. She DID NOT receive Epi-pen, and did not take ambulance to emergency department. However, she is reporting to emergency department for follow-up.
30 2021-02-06 injection site pain, injection site redness, injection site pruritus Fri. evening (1/29): fatigue, diarrhea, nausea Sat. (1/30): fatigue nausea Mon.-Thu (2/1-2/4); soren... Read more
Fri. evening (1/29): fatigue, diarrhea, nausea Sat. (1/30): fatigue nausea Mon.-Thu (2/1-2/4); soreness, redness and itching at injection site
30 2021-02-06 itchy rash, rash with redness, rash papular, rash Severe red and purple raised rash, extremely itchy, behind bilateral elbows, behind bilateral knees,... Read more
Severe red and purple raised rash, extremely itchy, behind bilateral elbows, behind bilateral knees, on bilateral calves, bilateral axilla, left wrist. Rash more severe on left side.
30 2021-02-07 redness Patient at site for 1st dose of COVID Vaccine. Patient approximately 2 minutes after receiving vacc... Read more
Patient at site for 1st dose of COVID Vaccine. Patient approximately 2 minutes after receiving vaccine at 1028 started feeling tongue swelling with throat itching. Patient taken to first aid room where she was assessed by provider and ems on duty. Patients skin was red and flushed and with slight swelling of the tongue noted. Patient still A7 O x4 with respirations even and unlabored. Patient had O2Sat of 96% on RA. Patient states she has an allergy to all Bovine proteins and had a mini-stroke approximately 4-5 years ago. Patient is a healthcare worker and is currently at home with newborn son. Provider ordered Benadryl 25mg PO and pt received 1st dose at 1045. Then provider ordered a second dose of Benadryl 25mg after patient stated her Jaw felt "Wonky" and patient received at 1048. Pt slowly responded to treatment and after 15 minutes from first dose of Benadryl patient had a decrease in redness and tongue swelling. Itching was slowly decreasing. At 1105 patient stated itching had subsided and by 1110 patient had a full return to baseline. Pt discharged at 11:15 home and pt communicated understanding that she was ok to drive and that she should follow up with PCP prior to receiving second dose of vaccine. Also, patient was able to communicate understanding of a rescue plan at home if symptoms should flare up again. Patient stated she did have an epi pen at home as well and note if she needed to she would use epi-pen and seek immediate medical attention after use.
30 2021-02-07 vaccination site swelling Sore arm; Swollen injection site and halo formation; This is a spontaneous report from a non-contact... Read more
Sore arm; Swollen injection site and halo formation; This is a spontaneous report from a non-contactable consumer reported for herself. A 30-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration on 20Jan2021 11:15 on right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at workplace clinic. Medical history and concomitant medications were not reported. The patient experienced sore arm within 20 minutes from vaccination on 20Jan2021 11:30, swollen injection site and halo formation at 18h on 20Jan2021. Soreness subsided after 72h. No treatment was received for the events. The outcome of the events were resolving. No follow-up attempts are possible. No further information is expected.
30 2021-02-07 vaccination site pain high fever of 101.8; body aches; headache; rigors/chills; shaking; increased pain at injection site;... Read more
high fever of 101.8; body aches; headache; rigors/chills; shaking; increased pain at injection site; one instance of vomiting; This is a spontaneous report from a contactable other health professional (patient). A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: El3302, via an unspecified route of administration on 20Jan2021 02:00 at a SINGLE DOSE for covid-19 immunization. Medical history included allergies to penicillin and cephalosporin. Patient received her first dose of BNT162B2 on 30Dec2020 at (12:00) (lot number: ELO140), (in the right arm) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient developed a high fever of 101.8 (unit not provided), chills, body aches, headache, rigors, shaking, increased pain at injection site, and one instance of vomiting starting approximately 6 hours after her second dose (for clarification) of the vaccine (20Jan2021, 20:00). the outcome of event was reported as 'recovering'. the patient did not receive any treatment due to the events. The events were considered as non-serious by the reporter. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
30 2021-02-07 vaccination site pain muscle aches; nausea; fever, Tmax 101.7; neck ache; soreness at sight of injection; This is a sponta... Read more
muscle aches; nausea; fever, Tmax 101.7; neck ache; soreness at sight of injection; This is a spontaneous report from a non-contactable nurse. A 30-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3247), intramuscularly on 21Jan2021 at 09:15 AM in the Left arm at single dose for COVID-19 immunization in hospital. Medical history included hasimoto's, known allergies with peanuts. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscularly on 30Dec2020 at 08:15 AM in the Left arm at single dose for COVID-19 immunization at the age of 30-year-old. The patient experienced fever, Tmax 101.7, muscle aches, neck ache, soreness at sight of injection, nausea on 21Jan2021 at 23:30. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included mefenamic acid (ADVIL). The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
30 2021-02-07 redness, skin irritation, itchy skin nervous; back started to itch/There was irritation; back felt itchy; back felt itchy and pinkish red... Read more
nervous; back started to itch/There was irritation; back felt itchy; back felt itchy and pinkish red/back was red; Arm soreness; This is a spontaneous report from a contactable consumer (patient) via a Medical information team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history included steel rods in back from 2006 and ongoing. The patient's concomitant medications were not reported. The patient was vaccinated and felt fine. She experienced arm soreness on 20Jan2021 originally. Then today, it was so bizarre, about an hour and a half ago, her back started to itch on 22Jan2021. There was irritation. She checked in the mirror, and her back was red on 22Jan2021. She was wondering if this was a reaction from the vaccine. She was getting nervous. A medical student gave her the vaccine. She didn't have a prescribing doctor. Twenty minutes after getting the vaccine, she noticed the arm soreness. It was worse yesterday, but today she thinks it is the same or maybe a little better. The irritation on her back seems a little better since she first noticed it. The outcome of the events back felt itchy and pinkish red and irritation was recovering. The outcome of the event arm soreness was not recovered. The outcome of the event nervous was unknown.
30 2021-02-08 injection site pain 5 hours later after the 2nd dose of vaccine. I had aching pain at the injection site and throughout ... Read more
5 hours later after the 2nd dose of vaccine. I had aching pain at the injection site and throughout my left arm, radiating to my chest (like squeezing or feels heavy) as well as nausea. On Sunday morning around 330 am, I had bad chills and temperature of 100.5 and had taken Tylenol prior to having chills. Later in the day, I had severe headache and fatigue.
30 2021-02-08 injection site pain, injection site warmth I received the shot around 1:45 pm and I felt a warm/ burning sensation in my arm. I waited there fo... Read more
I received the shot around 1:45 pm and I felt a warm/ burning sensation in my arm. I waited there for 15 minutes and nothing happened. I get home and still felt fine. Around 6:30 pm I started to feel neck pain and stiffness as I continued to do house chores the pain just kept going up towards my neck into my left cheek where I feel numbness. My throat and jaw hurt as well. My neck is stiff and I can?t look to the left unless I turn my body. The back my head is also starting to hurt. My arm is sore where the shot was given but what hurts most is my neck, throat and head. I have body chills but no fever. I took Tylenol and called the dr on demand who told me to take Benedryl and if the symptoms got worse to go to the hospital.
30 2021-02-08 itchy skin, rash Systemic: Rash (other than injection site)- Mild, Systemic: Nausea- Mild, Systemic: Vomiting- Mild, ... Read more
Systemic: Rash (other than injection site)- Mild, Systemic: Nausea- Mild, Systemic: Vomiting- Mild, Systemic: Other- pt had itchy eyes, arms, neck and numbness around eyes
30 2021-02-08 injection site pain diarrhea (7+ loose stools each day starting on this day); headache; severe nausea; worsened muscle p... Read more
diarrhea (7+ loose stools each day starting on this day); headache; severe nausea; worsened muscle pain; new joint pain morning after (Included in aforementioned, but significant stiff neck.); new joint pain morning after (Included in aforementioned, but significant stiff neck.); fatigue/malaise; fatigue/malaise; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) Intramuscular at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Other medications in two weeks includes fluoxetine, lorazepam, and Ibuprofen. Patient received first dose of bnt162b2 (lot number: EL0140) on 30Dec2020 and experienced injection sight tenderness, severe headache and fatigue. On 20Jan2021 5:00 PM after the second dose, patient experience headache, severe nausea, diarrhea (7+ loose stools each day starting on this day), worsened muscle pain several hours later, new joint pain morning after (Included in aforementioned, but significant stiff neck), fatigue/malaise. Patient received Ibuprofen and rest, supportive care due to events. The outcome of event was not recovered. Rapid Nasal Swab tested Negative on 21Jan2021.; Sender's Comments: The reported event diarrhea was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship, and considering no alternative cause reported currently. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
30 2021-02-08 rash rash, chest heaviness and shortness of breath
30 2021-02-09 vaccination site pain Chills; brain fog; fatigue/exhaustion; nausea; headache; site pain; fever; This is a spontaneous rep... Read more
Chills; brain fog; fatigue/exhaustion; nausea; headache; site pain; fever; This is a spontaneous report from a contactable health professional reporting for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not known) on 27Jan2021 at 09:00 via an unspecified route of administration at single dose in the right arm for COVID-19 immunization in the workplace clinic. The patient has no medical history. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID 19 vaccine and no other medications received within 2 weeks of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination. On 29Jan2021 at 7:00 AM the patient experienced chills, brain fog, fatigue/exhaustion, nausea, headache, site pain and fever. The patient has not been tested for Covid-19 since the vaccination. The events were assessed as non-serious. The patient did not receive treatment. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
30 2021-02-09 vaccination site pain Injection sight tenderness; Fatigue; Severe headache; This is a spontaneous report from a contactabl... Read more
Injection sight tenderness; Fatigue; Severe headache; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) intramuscular at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Concomitant medications include Fluoxetine, lorazepam, and Ibuprofen. Patient experienced injection sight tenderness, severe headache for 5 days, fatigue for 7-10 days after first dose. The outcome of events was unknown.
30 2021-02-09 rash Patient initially had some abdominal pain, which she attributed to be anxious/nervous about getting ... Read more
Patient initially had some abdominal pain, which she attributed to be anxious/nervous about getting the shot. Within 2-3 hours of the shot, she developed a rash on her neck, abdomen, and wrists. She said she never felt SOB or like her throat was closing. She was already taking Benadryl for eczema, and said the rash resolved in 48 hours.
30 2021-02-10 injection site pain Fever, Headache, Body Ache, Tiredness, Injection Site Pain
30 2021-02-10 injection site swelling She reports with a few minutes she felt light headed, dizzy and mentally disconnected. Symptoms incl... Read more
She reports with a few minutes she felt light headed, dizzy and mentally disconnected. Symptoms included feeling nonspecific discomfort, hot, cold, palpitations, nausea. She states her chest cavity felt strange and can best describe it as internal burning. She states breathing was strange, and was 'almost' SOB. She felt palpitations. They seated her in a chair for 15 minutes and observed her for 35-45 minutes. Her VS were normal. She denies pruritis, urticaria, flushing, sweating, cough, wheeze, oral/facial/throat/tongue swelling, red/watery eyes. She went home and continued to feel uncomfortable and restless. She had one emesis. She took a Tylenol pm at 19:00 and slept until about midnight. She reports the restlessness and discomfort stopped, but she then felt flulike symptoms (malaise, myalgias) for the next 3 days. She noted onset of edema at the injection site day 1, but no erythema or dermatitis.
30 2021-02-10 injection site pain Woke up at 3am with bad chills and headache. Took temperature and it was 100.0 degrees F. Drank wate... Read more
Woke up at 3am with bad chills and headache. Took temperature and it was 100.0 degrees F. Drank water and took 500mg of Tylenol and eventually went back to sleep around 5:30am. Continued to drink water when I woke up again around 8am. Took 1g of Tylenol around 9am. Continued to experience symptoms, including sore injection site, throughout the day although the Tylenol mildly helped alleviate symptoms. Experienced mild headache the following morning (2/10) but it went away after a couple of hours. No chills or fever on 2/10 but continued to have sore injection site through 2/11.
30 2021-02-14 vaccination site pain fever of 104 F; dizzy; my arm was so sore I could not lift it/ My body ached mostly in my legs and l... Read more
fever of 104 F; dizzy; my arm was so sore I could not lift it/ My body ached mostly in my legs and lower back; felt soreness at the injection site; felt extremely nauseated; My body ached mostly in my legs and lower back; Body aches/extreme tiredness; headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EJ1686. Medical history and concomitant medications were unknown. Historical vaccination included flu vaccine for immunization (vaccination site pain). About 6 hrs after vaccine on 07Jan2121, the patient felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine on 07Jan2021, arm was so sore that the patient could not lift it. That night the patient took two Tylenol and had to wrap arm in a heating pad. The patient woke up around at 03:00 on 08Jan2021 with a fever of 104 F; the patient was so dizzy from the high fever. The patient felt extremely nauseated on 07Jan2021. Body ached mostly in my legs and lower back on 07Jan2021. It hurt to sit on the toilet, to put on clothes. On 07Jan2021, the patient experienced body aches/extreme tiredness. On 07Jan2021, the patient experienced headache 8as reported). Fevers happened at night-time ranging from 102-104F for 4 days. Injection site soreness lasted for 7 days. Body aches/extreme tiredness lasted around 2-3 days. Dizziness subsided after fever broke, but it was replaced with a severe headache lasting 2 days (as reported). The patient was not COVID tested post vaccination. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
30 2021-02-15 injection site pain DEVELOPED SORENESS IN LEFT ARM AT INJECTION SITE THAT IS STILL ONGOING
30 2021-02-15 injection site pain Soreness at injection site starting night of 2/15. Ulnar numbness abs tingling in forearm and hand o... Read more
Soreness at injection site starting night of 2/15. Ulnar numbness abs tingling in forearm and hand of left arm. (Same side as injection)
30 2021-02-16 injection site pain Had an extremely sore arm at injection site. By late afternoon/early evening became extremely lethar... Read more
Had an extremely sore arm at injection site. By late afternoon/early evening became extremely lethargic and could not stay awake by 8pm on 1/13/2021. At around 1am on 1/14/21 I woke up with a fever of 101*F that lasted for roughly 6 hours. Fever eventually subsided after taking tylenol, drinking a lot of water, and using an ice pack. Still had some residual lethargy that lingered until the end of 1/15/2021.
30 2021-02-16 bruising tired, random bruising, fatigue, bone achy
30 2021-02-18 rash, redness, rash with redness 1/15/21 30-60MINS POST VACCINATION PT DEVELOPED FLAT RED RASH ALONG ANTERIOR REGION OF NECK . WITHIN... Read more
1/15/21 30-60MINS POST VACCINATION PT DEVELOPED FLAT RED RASH ALONG ANTERIOR REGION OF NECK . WITHIN 72HRS REDNESS SPREAD TO SKIN AROUND EYES BILATERALLY. ON 2/8/21 PT DEVELOPED EDEMA BILATERALLY AROUND THE EYES. EDEMA AROUND EYES IS SEVERE ENOUGH TO HAVE TO "PRY" EYES OPEN AND USE ICE PACKS TO REDUCE SWELLING AROUND 2/12/21 PT REPORTS RED RASH ON NECK SREADING TO POSTERIOR REGION OF NECK. 2/19/21 PT STATED SHE HAD TELEMED APPT WITH MD TO REVIEW PICTURES AND PT. PT WAS ADVISED TO TAKE CLARITIN OR ZYRTEC DAILY AND BENARDYL 25-50MG NIGHTLY.
30 2021-02-18 rash Rash, tachycardia
30 2021-02-18 hives She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction t... Read more
She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction to her first dose of the Pfizer Covid vaccine with acute hives within 15 minutes on 12/26. She had hives on her neck, arms chest, headache arm pain and mild dizziness. Symptoms resolved with Benadryl She received her second dose of the Covid vaccine 12/26 with immediate symptoms within 30 minutes of respiratory symptoms, shortness of breath, hives, dizziness, fainting with treatment of epinephrine on site at the Vaccine Site by ambulance to the ER. She reports she was hypoxic with O2 sat 70 to 75%. Went to hospital and received 3 doses of epinephrine, IV Benadryl, IV fluids, Pepcid, and 7 days of prednisone. 1/26: c/o chest tightness had video visit with primarily MD, continued diphenhydramine and refer to allergy. She does have a history of vaccine reaction in the past to Gardasiln (contains polysorbate 80) given at age 16 with delayed hives 24 hours later. Allergist assessment: Covid vaccine 19 mRNA anaphylaxis with 2nd dose and acute hives with 1st dose of Pfizer vaccine S/p repeated doses of epipen With ongoing asthma, dizziness, light headed , nausea and fast heart rate 1.5 weeks after anaphylaxis but normotensive With prior history of delayed hives with gardisil --may be sensitive to polysorbate 80 in both vaccines. Added COVID vaccine to allergy list
30 2021-02-18 itchy skin, redness Within 5 minutes, she developed itching in the right arm (opposite from injection site), itching on ... Read more
Within 5 minutes, she developed itching in the right arm (opposite from injection site), itching on back, redness on the right arm, dyspnea, "out of body experience," "sense of impending doom," chest tightness. Then, the nurse who observed her transported her to a bed to be evaluated. stated that she was tachycardic, short of breath and had erythema on both arms. An IV was placed 10 minutes later and 9-1-1 was called. She was given Pepcid, Benadryl and Solu-Medrol at the clinic before arriving to the emergency room. She was given Epinephrine approximately 1 hour after the reaction occurred as well as IV benadryl. She was sent home with prednisone.
30 2021-02-19 rash 1/30 Reaction tongue and lips tingling. Right arm w rash and chest tightening. Today lips 8and ton... Read more
1/30 Reaction tongue and lips tingling. Right arm w rash and chest tightening. Today lips 8and tongue tingling. EMS evaluated. BP 128/84 P 86 SaO2 98% No further issues resolved - home 2:55
30 2021-02-21 hives, rash Within less than 24 hours after receiving the vaccine I developed hives on my face. I have had break... Read more
Within less than 24 hours after receiving the vaccine I developed hives on my face. I have had breakouts of hives on my face every day since then. I have woken up with them in the morning and then they will come and go throughout the day up to 3 times. Also experienced rashes on my face. No pain, wheezing, or other adverse effects.
30 2021-02-22 itchy skin 1415: Patient with history of COVID 8/2020 presented today for second dose of vaccine after approxim... Read more
1415: Patient with history of COVID 8/2020 presented today for second dose of vaccine after approximately 5 minutes after patient had vaccine patient had syncopal episode, itching/ fullness. Covering physician present and assessed with EMS on Duty: VS: 110/80-BP, 18-RR, 96-HR, SaO2-98% on RA, CBG: 138 Patient awakened and reported "feeling funny" but was A & Ox4, MAEW x4 with equal strength, Lungs Clear to auscultation. 1420: Benadryl liquid PO given along with 8oz of water. Patient able to drink without issues. 1500: EMS called for ER transport to due prolonged recovery.
30 2021-02-22 rash Breakout of rash on hands lasting about 2 weeks
30 2021-02-23 vaccination site pain Pain at the injection site that started about 3hrs after injection; This is a spontaneous report fro... Read more
Pain at the injection site that started about 3hrs after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247, first dose) solution for injection intramuscular on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced pain at the injection site that started about 3 hours after injection. No treatment was provided for the event pain at the injection site. The outcome of the event pain at the injection site was unknown. The patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.
30 2021-02-23 rash Patient was experiencing rash and chills after her second dose of COVID19 vaccine, treated herself w... Read more
Patient was experiencing rash and chills after her second dose of COVID19 vaccine, treated herself with benadryl to resolve. Rash re-appeared following day, presented to the ED received solumedrol, fluids and benadryl, and she was discharged with ranitidine and hydroxyzine (2/21). She returned on 2/23 to ED, presented with rash, tachycardia and c/o abdominal pain . She was treated with methylprednisolone 15mg, 1L of LR, 1L of NS, and 50 mg IV diphenhydramine, 0.3 mg IM Epinephrine, and 20 mg of famotidine IVx1. Patient was continued on prednisone 40 mg po bid and famotidine 20mg po bid.
30 2021-02-25 vaccination site pain Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from... Read more
Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from a contactable consumer reporting for herself. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 10Feb2021 at single dose in Left arm for COVID-19 immunisation. Medical history included coeliac disease from an unknown date. There were no Allergies to medications, food, or other products. The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), on 20Jan2021 at the age of 30-year-old at single dose in Left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Painful left arm (where vaccinated). She experienced flu like aches the day after vaccination as well as feeling cold on 11Feb2021. Since the vaccination, the patient had not been tested for COVID-19There was no treatment received for the adverse event. The outcome of events was recovered. The events were reported as non-serious.
30 2021-02-25 injection site pain, injection site redness, injection site pruritus Pregnant, due date 03/27/2021; adverse event included localized reaction at site of injection, start... Read more
Pregnant, due date 03/27/2021; adverse event included localized reaction at site of injection, started out as dime sized red spot around site that grew to approximately 2" in diameter. It was very itchy and painful, required Benadryl, Tylenol and cortisone cream for treatment, and lasted approximately 2 weeks after injection. Only occurred after initial dose.
30 2021-02-26 injection site pain I woke up 4 days later 2/12, with both ear clogged or ear fullness. I felt out of balanced and a lit... Read more
I woke up 4 days later 2/12, with both ear clogged or ear fullness. I felt out of balanced and a little light headed. I also felt like my hearing was less. Next day 2/13 I only felt ear fullness on my left ear. 2/15 I woke up feeling fine. A week later 2/19 I woke up with the injection site hurting along with my leg ear clogged again. Again I felt out of balanced and light headed. I went to see an audiologist on the third day 2/21 while my ear was still clogged. They didn't see any wax or ear infection. They did a hearing test which showed normal hearing but worse on the left ear than the right. They told me I should see an ENT. 2/22 I woke up feeling fine. 2/24 I was asymptomatic when I went to see the ENT and my hearing test was normal but when they did a videonystagmography it showed significant positional nystagmus.
30 2021-02-27 itchy skin, rash vesicular 1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above righ... Read more
1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above right eyelid 1/3/21 - Diagnosed with Zoster Ophthalmicus of Right Eye at urgent care and initiated on Valacyclovir 1000 mg PO TID x 10 days 1/4/21 - Ganciclovir eye drops added to treatment course 1/10/21- Rash crusted and resolved but with severe neuropathic pain and itch 1/12/21 - Second dose of COVID vaccine received
30 2021-02-28 injection site mass, itchy skin 2-26-21 8pm bump quarter sized to injection site, numbness and tingling lasting half an hour after t... Read more
2-26-21 8pm bump quarter sized to injection site, numbness and tingling lasting half an hour after taking ibuprofen, today reports itching. reports area of bump is now larger at the size of a golf ball
30 2021-02-28 rash After my second Covid19 vaccine shot I developed symptoms such as headache, back aches, a rash, and ... Read more
After my second Covid19 vaccine shot I developed symptoms such as headache, back aches, a rash, and fatigue. This started at 6 am the next morning after the vaccine, and lasted for 24 hours. Except the headache which lasted about 48 hours. Rash is going away, but still itchy on bottom half of body.
30 2021-02-28 injection site pain Pain at injection site, fever, chills, joint aches, overly sensitive to physical stimuli. Began abou... Read more
Pain at injection site, fever, chills, joint aches, overly sensitive to physical stimuli. Began about 6 hours after vaccine was administered and lasted about 24 hours. Standard OTC dose of ibuprofen every 6 hours provided slight relief.
30 2021-03-01 bruising, injection site pain Fatigue (began noticing 8 hours after injection, slept a lot), body aches (20 hours after), chills (... Read more
Fatigue (began noticing 8 hours after injection, slept a lot), body aches (20 hours after), chills (20-24 hours after), fever (24-28 hours after). Symptoms continued until I took Tylenol following night (33 hours after injection). Pain/soreness at injection site almost immediately + swollen left underarm lymph nodes noticeable 40+ hours after. Tenderness and bruise-like pain there.
30 2021-03-01 injection site pain, injection site redness Fever, chills, body aches, fatigue, muscle weakness, and injection site pain, redness and tenderness... Read more
Fever, chills, body aches, fatigue, muscle weakness, and injection site pain, redness and tenderness.
30 2021-03-01 rash Patient reported rash on injected arm 2 weeks post vaccine at time of second vaccine. Approximately ... Read more
Patient reported rash on injected arm 2 weeks post vaccine at time of second vaccine. Approximately 5 min post second dose, patient noticed a rash starting already. Patient declined the need for treatment at time of vaccine. Patient ambulated without difficulty out of the vaccine clinic approximately 30 min. post vaccination.
30 2021-03-02 rash About 5 hour after receiving the vaccine I broke out in what looked like pimples/pox all over my tor... Read more
About 5 hour after receiving the vaccine I broke out in what looked like pimples/pox all over my torso (stomach, back, chest), legs, and arms. None on face, hands, or feet. Lasted (has not gone away) for 7 day now and has not been getting any better. Took oral Benadryl for 3 days no change.
30 2021-03-02 rash macular sudden rash appear on left side of my chest and shoulder, just visually a bunch of red dots; Swollen... Read more
sudden rash appear on left side of my chest and shoulder, just visually a bunch of red dots; Swollen lymph nodes, both collar bone and neck; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at the left arm on 26Jan2021 at single dose for COVID-19 immunisation. The patient has no medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (LUTERA). The patient experienced swollen lymph nodes, both collar bone and neck noticed the evening of 30Jan2021. Expected as much for an immune response, but then she had a sudden rash appear on left side of her chest and shoulder, just visually a bunch of red dots, no itching or discomfort the afternoon of 31Jan2021. She was reporting immediately, so no recovery yet. The patient did not receive any treatment for the events. The patient has not recovered from the events.
30 2021-03-03 itchy skin itching (itching affected her upper body, face, shoulders and torso).; This is a spontaneous report ... Read more
itching (itching affected her upper body, face, shoulders and torso).; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at arm left on 13Jan2021 at 12:00 (at the age of 30 years) at single dose for COVID-19 immunization. Medical history included pregnancy from an unknown date to an unknown date, dual venous thrombosis post pregnancy (from two years and four months ago) and blood thinner from an unknown date and ongoing. Concomitant medication included warfarin oral at 7.5 mg once a day from an unknown date and ongoing for blood thinner. The patient experienced itching (itching affected her upper body, face, shoulders and torso). The patient outcome of the event was not recovered.
30 2021-03-04 injection site pruritus, rash with redness, injection site reaction Itchy red Rash on upper left arm
30 2021-03-04 injection site pain Muscle pain and tightness at injection site. Not being able to lift arm past shoulder height. Pain w... Read more
Muscle pain and tightness at injection site. Not being able to lift arm past shoulder height. Pain with touch or movement of arm. Severe headache, joint pain, generalized body aches, low grade fever, fatigue, chills, nausea and weakness. Called in sick to work. Rest, drinking water, a hot bath, muscle ache cream, alternating Tylenol and Motrin.
30 2021-03-04 hives Patient was given vaccine and then sent to observation area for 15 minute observation. Patient appea... Read more
Patient was given vaccine and then sent to observation area for 15 minute observation. Patient appeared pale and diaphoretic when she got to the observation area and then suffered a syncopal episode. She was unconscious for several seconds. She did not hit her head or have any trauma. Patient complained of nausea, and dizziness when she regained consciousness. Patient appeared pale and diaphoretic. Patient then developed hives over her abdomen, upper torso, and upper arms. Patient never complained of difficulty breathing but was constantly pulling at the neck of her sweater. Pt was a Type I diabetic and had a BG reading of 262. She was given 0.3 mL of epinephrine with an immediate positive response. Transported to local hospital emergency room.
30 2021-03-05 injection site pain, itchy skin, rash Pfizer-BioNTech COVID-19 Vaccine EUA: patient developed soreness around injection site, chills, and... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient developed soreness around injection site, chills, and fever in the evening following vaccine administration. The next day developed rash, itching, and mild swelling below eyelids. Three days after vaccination patient reported tongue appeared red, bumpy, and a little swollen. Patient took diphenhydramine with some improvement overnight, then cetirizine the following day. It took another 24 hours- five days from vaccination- for tongue bumps and swelling to resolve.
30 2021-03-06 rash, rash with redness Bumpy, red rash turned flaky as it healed. Fatigued and feeling warmer than normal but no fever. Ras... Read more
Bumpy, red rash turned flaky as it healed. Fatigued and feeling warmer than normal but no fever. Rash on chest, back, and inner wrists. Benadryl taken twice daily until rashes subsided; about a week later.
30 2021-03-09 rash Patient had rash on back and thigh with erythematous pinpoint lesions improved with benadryl cream. ... Read more
Patient had rash on back and thigh with erythematous pinpoint lesions improved with benadryl cream. Doing well after 1 day of cream use.
30 2021-03-09 injection site irritation, injection site warmth, injection site swelling, injection site pain, injection site mass, injection site redness swelling, redness, heat at injection site, pain, and a round lump under the skin. lasted for one we... Read more
swelling, redness, heat at injection site, pain, and a round lump under the skin. lasted for one week over the course of 5 days, swelling, redness, and irritaiton became larger
30 2021-03-09 itchy skin syncopal episode; itching; fullness; feeling funny; This is a spontaneous report from a contactable ... Read more
syncopal episode; itching; fullness; feeling funny; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), intramuscular on 19Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included manual vacuum aspiration (MVA), traumatic brain injury (TBI) from 2007 to an unknown date, vagovasal and hypotension post TBI, Celiac disease, allergy to milk products, diagnosed with COVID-19 from Aug2020 to an unknown date prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included famotidine, methylphenidate, fludrocortisone, omeprazole, desvenlafaxine succinate (PRISTIQ), brexpiprazole (REXULTI), and folic acid. The patient was previously vaccinated with the first dose of bnt162b2 (lot number: EL3246) at the age of 30-year-old, intramuscularly for COVID-19 immunisation on 19Jan2021 at 14:15 and experienced heart flutters and "fell faint" (fainted). The patient also previously took ibuprofen and experienced allergies. After approximately 5 minutes after the patient had the second dose of vaccine (19Feb2021 14:20), the patient had syncopal episode, itching/ fullness. Covering physician present and assessed with EMS on Duty: VS: 110/80-BP, 18-RR, 96-HR, SaO2-98% on RA, CBG: 138. Patient awakened and reported "feeling funny" on 19Feb2021, but was A &Ox4, MAEW x4 with equal strength, Lungs Clear to auscultation. At 14:20 the patient was given Benadryl liquid PO given along with 8oz of water. Patient able to drink without issues. At 15:00, EMS called for ER transport to due prolonged recovery. The events resulted in emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-03-11 itchy skin, redness Patient developed generalizd skin redness and itching. Received 50 mg Diphenhydramine, PO. Patient o... Read more
Patient developed generalizd skin redness and itching. Received 50 mg Diphenhydramine, PO. Patient observed vital signs q5 min. Symptoms improved. Patient left with husband, stable, alert and oriented, and ambulating.
30 2021-03-13 rash, rash macular, itchy rash, hives, dry skin Red, itchy spots on stomach and side of torso. Appeared about 24 hours after first dose. Still visib... Read more
Red, itchy spots on stomach and side of torso. Appeared about 24 hours after first dose. Still visible over 48 hours after. Started out as what looked like itchy hives, now they?re just rough, red, itchy patches.
30 2021-03-14 itchy skin, blister Described as "COVID toes" a little over a week from the first dose of Pfizer COVID vaccine, the thre... Read more
Described as "COVID toes" a little over a week from the first dose of Pfizer COVID vaccine, the three small toes on my left foot started to itch like I had gotten a mosquito bite in between my toes. Within 12 hours, the itching got much worse and my three toes started to swell. The itch was bad enough that I couldn't sleep, but I wouldn't say there was much pain. I noticed a cut in between a couple of my toes and a small blister. I thought it was Athlete's foot until a colleague told me about COVID toes. I've been taking Benadyrl and using athlete's foot products (Lotrimin) that have been helping with the itch. Going on day 5 with some reduction in swelling.
30 2021-03-14 rash I am currently 22 weeks pregnant with expected date of delivery July 16th 2021. I was diagnosed with... Read more
I am currently 22 weeks pregnant with expected date of delivery July 16th 2021. I was diagnosed with epilepsy in January of 2017. In 2019 i began using lamictal and had zero problems with the anti -seizure medication. One week after my second dose of vaccine i developed a significant rash and experienced extreme difficulty breathing. After seeing a dermatologist and getting a biopsy i was told that i had DRESS syndrome which is very uncommon given i had already been on lamictal for such a long period of time. I have been prescribed a topical steroid as well as 40mg prednisone and am titrating off the lamictal to the keppra (1500mg).
30 2021-03-14 injection site swelling Started with burning nasal cavity then sore throat started and now congested body aching and arm of ... Read more
Started with burning nasal cavity then sore throat started and now congested body aching and arm of injection is swollen.
30 2021-03-14 itchy skin, rash rash, itching, hot chest and neck, post nasal drippage, left arm feels hot, right arm itchy, itchy t... Read more
rash, itching, hot chest and neck, post nasal drippage, left arm feels hot, right arm itchy, itchy throat
30 2021-03-15 hives Hives on side of body injection site; This is a spontaneous report from a contactable other health p... Read more
Hives on side of body injection site; This is a spontaneous report from a contactable other health professional (patient). A none pregnant 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN, Solution for injection, Lot/Batch Number and Expiration Date unknown), via an unspecified route of administration, administered in right arm on 16Feb2021 at time of 13:00 (at the age of 30 years old, no pregnant at vaccination) at a single dose for COVID-19 immunization. The patient had no other medical history. No known allergies. There was no concomitant drugs. There was no other vaccine in four weeks and no other medications in two weeks. The patient did not have covid prior vaccination and did not receive covid tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN, lot number unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced hives on side of body injection site on 17Feb2021. Therapeutic measures were taken as a result of "hives on side of body injection site" and included treatment with "use of diphenhydramine (BENADRYL) and paracetamol (TYLENOL)". The outcome of event was recovering. No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
30 2021-03-16 rash rash 3 days after.
30 2021-03-17 itchy skin C/o Generalized itchiness. No rash visible. VSS 123/84 HR 74 100% on RA RR 16. No tongue, lip swelli... Read more
C/o Generalized itchiness. No rash visible. VSS 123/84 HR 74 100% on RA RR 16. No tongue, lip swelling, no hives. No chest pain, sob. No hx of prior vaccine reaction. Hx of allergies to strawberries with anaphalaxis. Vaccine received at 0925. Pt still c/o itchng at 10:05. Will send to ER for further monitoring as may need antihistamines, steroids, h2 blockers. No signs of anaphalaxis. Will need further monitoring. ED Note: This is a well-appearing and pleasant 30-year-old female who presented to the emergency department for generalized body itching following getting the first dose of Pfizer COVID-19 vaccine at approximately 930 this morning. On presentation patient is well-appearing, respirations are even and nonlabored, she is speaking in complete sentences with normal work of breathing. She denies any symptoms other than itching currently on her upper arms and upper back. She notes that the itching is already starting to resolve and has lessened. There is no rash present on exam, no hives. Airway is clear, uvula midline, patient is tolerating secretions well with no drooling or voice changes and there is no mouth or tongue swelling present. Neck is supple without lymphadenopathy. Patient was observed close to an hour and a half and she remained stable with no changes. At time of discharge patient with no skin reaction, facial, mouth, or tongue swelling. She is speaking in complete sentences with normal work of breathing, respirations even and nonlabored. She appears well and appropriate for discharge. I had an in-depth discussion with her regarding monitoring her symptoms at home seeking emergent care if she has any compromise. We discussed all signs and symptoms that she should look for that would be concerning and need emergent intervention. She indicated that she understood all instructions. Patient was given the opportunity to ask questions. All questions and concerns were thoroughly addressed. Patient indicated she understood all instructions was comfortable with this plan of care. No evidence of Stevens-Johnson syndrome, anaphylaxis, cellulitis, or systemic compromise. Feel supportive care and symptomatic treatment reasonable. I reviewed recent and relevant Chart Entries, Previous Notes, Previous Labs, Previous Radiology studies. Patient ambulated out of the emergency department with a steady gait. Received benadryl and famotidine in the ED and take home prescriptions for famotidine and hydroxyzine.
30 2021-03-18 itchy skin At 13:55 on 3/19/21 patient received 1st Pfizer vaccine to left arm. At 14:05 on 3/19/21 patient dev... Read more
At 13:55 on 3/19/21 patient received 1st Pfizer vaccine to left arm. At 14:05 on 3/19/21 patient developed itching to bilateral lower and upper arms. Denies shortness of breath, denies trouble breathing, denies chest pain, denies hives.
30 2021-03-18 injection site mass, redness, itchy skin, injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA headache first day, immediate itching and redness and lump at i... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA headache first day, immediate itching and redness and lump at injection site, nausea and shortness of breath, tenderness on injection site, arm soreness it is now day 9 since my 1st shot, and everything else has gone away except for the redness, itchiness, and the lump size which has progressively gotten worse not cleared up in 7 to 10 days
30 2021-03-18 redness, hives Red Hives from neck down - Benedryl and rest
30 2021-03-18 rash, itchy skin, itchy skin, rash Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Genera... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
30 2021-03-18 rash papular, hives, rash Widespread hives all over body, under hair, raised bumps--especially on the back. Over 2.5 days, hiv... Read more
Widespread hives all over body, under hair, raised bumps--especially on the back. Over 2.5 days, hives remain.
30 2021-03-18 vaccination site pain injection site pain; chills; flushing; tired; unable to sleep; It felt like I had a fever but my tem... Read more
injection site pain; chills; flushing; tired; unable to sleep; It felt like I had a fever but my temperature did not go above 98.6.; This is a spontaneous report from a contactable Other HCP. A 30-years-old female patient (Other HCP) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL1283) via an unspecified route of administration on 26Jan2021 at single dose for Covid-19 immunization. Medical history included panic attack from an unknown date and unknown if ongoing and not known drug allergies (NKDA). The past drug included received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EJ1685) via an unspecified route of administration on 05Jan2021 10:30 AM at single dose for Covid-19 immunization. The patient's concomitant medications included multivitamins (Smartypants) and birth control. As per adverse event description, 14 hours after the injection on 27Jan2021 at 03:00 AM, she began to have injection site pain, chills, flushing, tired/unable to sleep. It felt like she had a fever but the temperature did not go above 98.6. The outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
30 2021-03-19 itchy skin Patient described trunk based pruritis that resolved within 15-30 minutes.
30 2021-03-19 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA: Injection site pain, woke me up whenever I tried to move my le... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Injection site pain, woke me up whenever I tried to move my left arm for the whole night. I didn't sleep well because of that.
30 2021-03-20 skin irritation JIA flare-up (inflammation in jaw, knees, ankles) H. Sup flare-up (inflammation if skin, increase i... Read more
JIA flare-up (inflammation in jaw, knees, ankles) H. Sup flare-up (inflammation if skin, increase in active spots)
30 2021-03-20 rash Redness and itching to left arm that started approximately 30 minutes after administration. Redness ... Read more
Redness and itching to left arm that started approximately 30 minutes after administration. Redness and itching spread across body into a generalized rash. Itching to throat but no respiratory issues- no shortness of breath or trouble breathing. Took two Benadryl tablets and a Pepcid tablet around 745pm when I got home.
30 2021-03-21 skin discolouration Brown spot appeared on palm of hand. Approximately 1/3? long.
30 2021-03-21 itchy skin I had an allergic reaction to the Pfizer vaccine. After 10-15 minutes from receiving the vaccine, my... Read more
I had an allergic reaction to the Pfizer vaccine. After 10-15 minutes from receiving the vaccine, my face got itchy but it was mild so I left after 25 minutes of waiting. Over the next hour the itching got more noticeable (no rash) and my throat felt slightly swollen, although I had no difficulty breathing or talking. I called a pharmacy that advised I take Benadryl, which helped. The next morning my face was still itching and it felt like there was a lump in my throat. I went to urgent care and received a steroid shot and prescription for Atarax, although the pharmacy was closed, so I just ended up taking more Benadryl. Today, 2 days after the vaccine, my face no longer itches and my throat feels normal. Just feel moderately fatigued, although I think that is a normal side effect.
30 2021-03-21 injection site swelling, injection site redness Nausea, fatigue, red swollen injection site, light headedness lasting 4 days
30 2021-03-21 injection site bruising, injection site swelling Nonstop Fever, chills, exhaustion, and nausea for 3 days. Where shot was placed, right arm swelled ... Read more
Nonstop Fever, chills, exhaustion, and nausea for 3 days. Where shot was placed, right arm swelled and bruised for 3 weeks.
30 2021-03-21 rash, bruising, injection site irritation Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/19/2021 9:22 AM Expand AllColla... Read more
Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/19/2021 9:22 AM Expand AllCollapse All Clinic 3/18/2021 Patient: Date: 3/18/2021 Subjective Patient is a 30 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience paresthesia down R arm. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling, tongue swelling and weakness in arm. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms. PMH insignificant ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + paresthesia in R arm: Previous Reactions: none Objective Vitals Vitals: 03/18/21 1430 BP: 108/62 Pulse: 72 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No facial asymmetry. Sensory: Sensation is intact. Motor: No weakness. Coordination: Coordination is intact. Gait: Gait normal. Comments: + 5/5 strength against resistance to bilateral upper extremities. Pt able to put on her own sweater without difficulty or assistance. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: ice pack Follow up response to treatment: fair. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Suspect superficial nerve secondary to injection. Discussed ice/warm cloth, movement of R arm. Follow up with pcp as needed. We will check in with her tomorrow via phone. Pt voiced appreciation of evaluation today. Nurse Practitioner Electronically Signed 3/18/2021 8:58 AM
30 2021-03-22 injection site redness, injection site swelling Around the site where I got the shot is now red and slightly raised.
30 2021-03-22 skin warm, injection site redness, injection site rash I had the 2nd vaccine on Friday night and had a headache and arm pain. I woke up on Saturday morning... Read more
I had the 2nd vaccine on Friday night and had a headache and arm pain. I woke up on Saturday morning with arm pain again and a red, raised rash where my injection site was. about the size of a half dollar and it was warm to the tough Arm pain went away by Sunday but the rash grew to about the size of a golf ball in diameter and it was egg shaped and became darker red. Monday the rash did not grow anymore but was still warm to the touch and there was pain if I pushed on the rash. It was getting lighter in color. Right now on Tuesday, rash has gotten even more lighter to just a pink/almost skin color, it has not grown in size.
30 2021-03-22 itchy skin Post-vaccination evaluation: Pt waiting in waiting area after receiving Pfizer vaccine 5 minutes pr... Read more
Post-vaccination evaluation: Pt waiting in waiting area after receiving Pfizer vaccine 5 minutes prior. Reported nausea. Brought back to vaccine area, pt was sat in chair, cool cloth applied to back of neck. Alcohol wipe given to help nausea. Pt reports itching on chin, neck and chest. No rash noted. Vital signs taken B/P 110/85, pulse 95, O2 sat 100%, R18. Pt produced emesis of 100 ml of drainage. Pt continues to report nausea and itching. Cool clothes applied, feet elevated. Pt produced another 100 ml of emesis. Pt given ice to back of neck. States nausea easing up. 18:35 - patient continues to itch abdominal area. No rash noted. Instructed to call PCP tomorrow to determine if second vaccine should be given. 18:38. Pt discharged to significant other. Ambulates with assistance of significant other. Patient and SO instructed to proceed to ER if symptoms progress or if has any involvement with respiratory. Patient stated itching and nausea was improving. 30-45 minutes: - Patient does exhibit signs and symptoms of adverse reaction to the vaccination. - Plan for follow up: Patient will follow up with PCP and allergist. Patient waiting to schedule 2 nd dose at this time
30 2021-03-22 injection site pain Swollen lymph nodes in left armpit. Tenderness under left armpit. Bump in left armpit.
30 2021-03-23 hives Anaphylaxis, hives
30 2021-03-23 redness Fever a few hours after receiving vaccination. 99.5 after taking ibuprofen. felt flushed and red in ... Read more
Fever a few hours after receiving vaccination. 99.5 after taking ibuprofen. felt flushed and red in the face.
30 2021-03-23 rash Patient sent to emergency department from nearby vaccine clinic with tachycardia (HR 138). She recei... Read more
Patient sent to emergency department from nearby vaccine clinic with tachycardia (HR 138). She received her second dose of the Pfizer vaccine approximately 45 minutes prior to arrival to ED. On arrival to ED she also had abnormal sensation in the back of her throat, change in her voice, and a new rash which developed few minutes prior to arrival. At this point, with signs and symptoms c/w anaphylaxis, she was given IM epinephrine, solumedrol, Benadryl, and famotidine. Symptoms improved entirely after 3-hour observation period and she was discharged home on EpiPen, prednisone, Benadryl, and famotidine.
30 2021-03-23 blister, shingles, rash Shingles on the same arm that received the injection. Skin rash and water blisters. Burning pain, fo... Read more
Shingles on the same arm that received the injection. Skin rash and water blisters. Burning pain, following nerve pain.
30 2021-03-24 injection site pruritus, injection site hardening, injection site redness, injection site warmth Got a red mark at injection site in first day and it is gradually getting bigger and very hot and de... Read more
Got a red mark at injection site in first day and it is gradually getting bigger and very hot and dense. And itchy.
30 2021-03-25 hives The Pt is a 30 year old female who presents with urticaria to the right neck 25 minutes following 1s... Read more
The Pt is a 30 year old female who presents with urticaria to the right neck 25 minutes following 1st dose Pfizer vaccination to the left deltoid. She has a Hx of seasonal allergies and childhood asthma but currently takes no medications. Pt endorses allergy to penicillin and notes similar skin rash as the reaction. Pt denies any Hx of severe allergic reactions. Currently the Pt denies any swelling of the face/lips/eye, difficulty swallowing, tightness of the throat, or itching of the skin. She also denies dizziness, diaphoresis, or vision changes.
30 2021-03-25 itchy skin When I first got the vaccine I had a flush reaction (felt like I had an IV and they had just flushed... Read more
When I first got the vaccine I had a flush reaction (felt like I had an IV and they had just flushed the IV). I felt dizzy. It went away quickly. 5 mins later I had diarrhea. I was also feeling post nasal drip, itchy throat, my chest had a burning sensation from the inject arm towards the middle of my chest. Throat was closing and tongue and lips were swelling. Entire body was itchy.
30 2021-03-26 hives, itchy skin Hives, itchiness, swollen and itchy tongue/lips, mild wheezing. I took zyrtec before I noticed sympt... Read more
Hives, itchiness, swollen and itchy tongue/lips, mild wheezing. I took zyrtec before I noticed symptoms beginning, which probably helped. The next day, as the zyrtec started to wear off, my tongue/lips began to feel itchy and mildly swollen again. I called my doctor but did not go to the hospital
30 2021-03-26 itchy skin, hives Tongue tingling, itching, hives
30 2021-03-27 skin irritation, itchy skin, redness Red, itchy and irritated at base of left palm
30 2021-03-28 injection site pain Soreness to the injection site only. First pregnancy. Estimated date of delivery Sept 22nd.
30 2021-03-30 vaccination site pain Heartbeat 15-20 bpm higher than my normal; Chest tightness; Difficulty breathing; Dizziness; Injecti... Read more
Heartbeat 15-20 bpm higher than my normal; Chest tightness; Difficulty breathing; Dizziness; Injection site pain; Headache; Tiredness/ Extreme exhaustion; Muscle pain; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9261), via an unspecified route of administration on Arm Left on 25Jan2021 18:30 as single dose for COVID-19 immunisation in hospital. Medical history included seasonal allergy and Known allergies. Concomitant medications included unspecified medications received within two weeks. The patient did not receive other vaccines within four weeks. The patient not had COVID prior vaccination. The patient was not tested for COVID post vaccination. On 25Jan2021 22:30, the patient was totally fine for 4 hours. After 4 hours she started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hours mark (on 26Jan2021), she started having a heartbeat 15-20 bpm higher than her normal, chest tightness, difficulty breathing, and dizziness. She was now 3.5 days post vaccine dose 1 and still having all of the symptoms in her last sentence plus extreme exhaustion, muscle pain, and fever. The events result in doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a for all the events. The outcome of the events was reported as not recovered.
30 2021-03-30 skin discolouration cardiac arrhythmia; dizziness/lightheadedness; nausea; muscle weakness; extreme fatigue; lost consci... Read more
cardiac arrhythmia; dizziness/lightheadedness; nausea; muscle weakness; extreme fatigue; lost consciousness/She is in and out of consciousness; extreme weakness; extremely low blood pressure; tachycardia when resting/heart rate is high/HR gets up to 135; One foot and leg became very cold and turned blue; One foot and leg became very cold and turned blue; other foot warm and hot; This is a spontaneous report from a contactable consumer (patient's sister). A 30-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EN/ EW 6198; expiration date: unknown), at vaccination age of 30-year-old via an unspecified route of administration in the left arm on 02Mar2021 as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with covid prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EN6198), at vaccination age of 30-year-old via an unspecified route of administration in the left arm on 09Feb2021 as a single dose for covid-19 immunisation but had weakness, fainted, lost consciousness and concussion. There were no concomitant medications. The patient did not receive other vaccine in four weeks. The reporter mentioned that on the next day after vaccination (03Mar2021), the patient's one foot and leg became very cold and turned blue other foot warm and hot started cardiac arrhythmia, dizziness, lightheadedness, nausea, muscle weakness, extreme fatigue, extremely low blood pressure and tachycardia when resting. The reporter stated that since 02Mar2021, she hasn't been able to get out of bed due to extreme weakness. The reporter also mentioned that her heart rate (HR) gets up to 135 [unit unspecified]. The reporter also stated that the patient was wearing a heart monitor and was waiting for data. They went to the emergency room (ER) on 12Mar2021 due to concerns of blood clot, ruled out blood clot. The doctors can't explain what is happening to her. She was extremely healthy and fit, no previous cardiac or energy issues. No blood pressure issues or family HX. She says she "feels like she's dying". The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life-threatening illness (immediate risk of death from the event). The hospitalization was reported as 1 day. It was unknown if the events received treatment. The patient was not tested post vaccination. It was further reported that her sister had the second Covid shot 02Mar2021 and a few hours later she lost consciousness. She has been in the hospital ever since. She was in and out of consciousness, her blood pressure is low, and her heart rate is high. One of her legs is blue and cold, the other is hot. She cannot get out of the bed. The doctors don't know what is wrong. It was mentioned that the patient was healthy and not taking any medication. The outcome of the events was not recovered.
30 2021-04-01 hives, itchy skin, skin tightness However at 2pm symptoms came back as before along with chest tightness and hives.; However at 2pm sy... Read more
However at 2pm symptoms came back as before along with chest tightness and hives.; However at 2pm symptoms came back as before along with chest tightness and hives.; after 5 mins felt tightness in my throat; felt skin tightness; followed by itchy face, eyes and stomach; developed a cough; This is a spontaneous report from a contactable consumer. A 30-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 11:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included arthritis reactive from Aug2020 , thyroid cancer from Aug2020. Concomitant medications included lansoprazole (LANSOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; etodolac (ETODOLAC) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELECOXIB) taken for an unspecified indication, start and stop date were not reported. The patient after 5 mins felt tightness in her throat, felt skin tightness, followed by itchy face, eyes and stomach, developed a cough on 19Mar2021 with outcome of recovering , however at 2pm symptoms came back as before along with chest tightness and hives on 19Mar2021 14:00 with outcome of recovering. All the reported events were considered serious because Impotant Medical Events. Course of the event. Adverse event: after 5 mins felt tightness in the throat, then felt skin tightness, followed by itchy face, eyes and stomach, and developed a cough. At 1200 the patient was given 25mg of Benadryl, and then another dose at 12:30. This improved symptoms and the patient was starting to consider going home. However at 2pm symptoms came back as before along with chest tightness and hives. she was given another 25mg of Beandryl and an ambulance was called. In the hospital they gave epinephrine, famotidine and methylprednisolone, which helped almost immediately. After a few hours she was discharged home. Follow up information has been requested. Lot number already obtained.
30 2021-04-11 skin discolouration After injection pt was escorted by RN to observation area. In route, patient passed out. Color becam... Read more
After injection pt was escorted by RN to observation area. In route, patient passed out. Color became dusky. Spo2 was 88-100 %. Dr ordered Epi Pen to be administered to left thigh at 1258. EMS was notified and patient taken to Hospital. Upon arrival to ED pt reports she became suddenly dizzy then woke up in the ED. She experienced chest tightness, sore throat, tongue swelling. Second epi was given in the ED. Developed muscle stiffness in the ED.
30 2021-04-14 injection site pain, injection site numbness Site: Pain at Injection Site-Medium, Additional Details: patient reported that she experienced numbn... Read more
Site: Pain at Injection Site-Medium, Additional Details: patient reported that she experienced numbness after inection which disappeared afterwards, but she is still experiencing a stiff neck 3 days after receiving the vaccine and is concerned about getting the second dose. I recommended her for a follow up with her primary care which she said she doesn't have and to go to the urgent care if pain is unbearable. patient is concerned that she may have experienced a pinched nerve after the shot itself.
30 2021-04-18 rash macular Swelling on right side of face; right eye swelled shut; labored breathing; red splotches on face and... Read more
Swelling on right side of face; right eye swelled shut; labored breathing; red splotches on face and arm; extreme fatigue and fog; extreme fatigue and fog; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 16:45 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior vaccination, and has not been tested for Covid-19 since vaccination. Patient was not pregnant at time of vaccination. Concomitant medications reported included bupropion hydrochloride (WELLBUTRIN XL) for unspecified indication, start and stop date not reported. On 31Mar2021 17:30, patient experienced swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm, and extreme fatigue and fog. Therapeutic measures were taken as a result of swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm and extreme fatigue and fog. The adverse events resulted on emergency room/department or urgent care. Patient received steroids, inhaler and allergy medicine. Outcome of the event labored breathing and extreme fatigue and fog (feeling abnormal) recovered on unspecified date, while others were recovering. The vaccine was administered in a Pharmacy or Drug Store. Follow up attempts are needed. Information on lot/batch number was requested.
30 2021-04-26 shingles I was given a diagnosis of shingles 4 days after receiving my first dose
30 2021-04-27 itchy skin Instant allergic reaction to injection; itchy; arm is numb where they injected the vaccine; This is ... Read more
Instant allergic reaction to injection; itchy; arm is numb where they injected the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Ew0162, first dose) solution for injection intramuscular in the left arm on 10Apr2021 at 11:30 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included sulfa allergy. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had an instant allergic reaction to injection, it's still very itchy, also my arm was numb where they injected the vaccine on 10Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included diphenhydramine (BENADRYL). The outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
30 2021-04-27 shingles Shingles on left side of body
30 2021-05-07 itchy skin Angioedema of left arm at the inoculation site; Pruritus; Inflammation; Pain; edema; Lethargy; arthr... Read more
Angioedema of left arm at the inoculation site; Pruritus; Inflammation; Pain; edema; Lethargy; arthralgia/shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 20Apr2021 at 11:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included penicillin allergy, HAE (hereditary angioedema), endometriosis, narcolepsy and depression, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received NSAIDs for an unspecified indication on an unspecified date and experienced allergy. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 30Mar2021 at 16:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Concomitant medications (other medications in two weeks) included bupropion, desvenlafaxine, oxybate sodium (XYREM) and icatibant, all taken for unspecified indications on unspecified dates. The patient did not receive another vaccine within 4 weeks prior to the COVID-19 vaccination. On 20Apr2021 at 13:15 the patient experienced angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain. The clinical course was reported as follows: "Angioedema of left arm at the inoculation site. Diameter of 70 mm. Pruritus subsided within 72 hours. Inflammation remains at present: Approx 96 hours after injection. Pain accompanies edema when pressure is applied. Lethargy and arthralgia for 72 hours. Shoulder joint pain. Note: patient's arm is thin; angioedema extended from anterior to posterior sides of the arm." The patient did not receive treatment for the events. The clinical outcomes of the events angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain were recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.
30 2021-05-10 hives Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth s... Read more
Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); This is the spontaneous report received from a contactable other health professional. This other HCP (patient) reported for herself that a 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) at the age of 30-years, via an unspecified route of administration in left arm on 19Mar2021 13:00 at single dose for COVID-19 immunization, in hospital. Medical history included PTSD, anorexia, chronic migraines, bradycardia. Patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included propranolol, atorvastatin (LIPITOR), prazosin, alprazolam (XANAX). On 19Mar2021 13:15, the patient experienced allergic reaction-characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling). After medical treatment, hives continued for 3-4 days. The events result in doctor or other healthcare professional office/clinic visit. The patient received high dose diphenhydramine hydrochloride (BENADRYL) and epinephrine (EPIPEN). Outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Allergic reaction, Anaphylactic reaction. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
31 2020-12-31 injection site pain Soreness at site of injection
31 2021-01-02 injection site hives, injection site redness, rash, hives, itchy skin, injection site pruritus Developed mild redness, hives, and itching at site of injection on days 2 and 3. Symptoms completely... Read more
Developed mild redness, hives, and itching at site of injection on days 2 and 3. Symptoms completely resolved independently on days 4 and 5. On day 6, developed significant welt-like hives, intense burning and itching, and numbness/tingling of entire extremity. Also developed a non-pruritic, flat, diffuse, pinpoint rash to the trunk. Rash and itching resolved with Benadryl. Right upper extremity burning, pain, and numbness persist.
31 2021-01-03 injection site pain 1 week after receiving the vaccine in the right arm, lymph node in the right arm pit became swollen ... Read more
1 week after receiving the vaccine in the right arm, lymph node in the right arm pit became swollen and painful. Also, right upper chest lymph node swelling and pain. Continuing to have vague/dull pain in right upper arm.
31 2021-01-04 vaccination site pain Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck... Read more
Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing)/ Left and right neck pain; Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing); Arm Pain at injection site; Arm Pain at injection site; This is a spontaneous report from a non-contactable physician (patient). A 31-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: EK5730), intramuscularly on 22Dec2020 09:45 at single dose on left arm for COVID-19 immunization in hospital. Medical history included gastrooesophageal reflux disease (reported as GERD). No true allergies; unable to take NSAIDs or eat bananas or avocados 2/2 GERD. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain at injection site on Day 1 (22Dec2020); chest, back and left neck pain (chest and back pain worse with breathing) on Day 2 (23Dec2020); left and right neck pain on Day 3, resolved on Day 4. No treatment received for the adverse events. The events outcome was resolved on 25Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. No follow-up attempts are possible. No further information is expected.
31 2021-01-04 hives Hives; This is a spontaneous report from a non-contactable physician. A 31-year-old female patient r... Read more
Hives; This is a spontaneous report from a non-contactable physician. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Dec2020 in left arm at single dose for COVID-19 immunization. Medical history included rheumatoid arthritis and known allergies to fire ants from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL) and drospirenone, ethinylestradiol (YASMIN). The patient experienced hives in Dec2020. The facility where the most recent COVID-19 vaccine was administered was on the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered in Dec2020. Therapeutic measure such as anti-histamine was taken as a result of hives. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are possible, information about lot/batch cannot be obtained.
31 2021-01-04 vaccination site itchiness, vaccination site pain, vaccination site swelling Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3... Read more
Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; This is a spontaneous report from a non-contactable Other healthcare professional (HCP) (patient). A 31-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E4284), via an unspecified route of administration on 22Dec2020 11:30 at a single dose in left arm for COVID-19 immunization. Medical history included asthma, known allergies: dust mites. The patient experienced soreness on day 2 (24Dec2020) and day 3 (25Dec2020), site of injection was swollen, painful, and itched on 24Dec2020. No other vaccine in four weeks received. No treatment received for these events. The patient had no COVID prior vaccination or no COVID tested post vaccination. This is a non-serious report. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
31 2021-01-04 vaccination site warmth, vaccination site pain, itchy skin light headed; soreness to site of injection; felt a random itch run along from my hand to up along m... Read more
light headed; soreness to site of injection; felt a random itch run along from my hand to up along my arm; some warmth to the site; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), intramuscularly on 23Dec2020 07:30AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included depression from an unknown date. No allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. Concomitant medication included fluoxetine. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. At the day of 23Dec2020 at 7:30 am the time of injection patient felt okay. She was let go to go back straight in to work. Once at work she felt light headed for 30 minutes with soreness to site of injection. Patient also felt a random itch run along from her hand to up along her arm. She applied lotion to the site if irritation for some comfort. The next 2 days patient still felt soreness and some warmth to the site. It's unknown if patient received treatment for the other adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The date report was first received from source was 27Dec2020. The events were reported as non-serious. No follow up attempts are possible; information about lot/batch number cannot be obtained.
31 2021-01-04 injection site pain, hives, rash received vaccine 1600 and then developed hive like rash on anterior neck only which has continued an... Read more
received vaccine 1600 and then developed hive like rash on anterior neck only which has continued and patient will be evaluated today 12/24/2020. She did not develop any other allergic reaction symptoms and only other symptom is mild soreness to her arm where she received the vaccine.
31 2021-01-04 hives, redness, itchy skin whole left arm was numb/numbness and itching happened also to the soles of feet; itching happened al... Read more
whole left arm was numb/numbness and itching happened also to the soles of feet; itching happened also to the soles of feet/hands also became red and itchy; hands also became red; hives; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient (non-pregnant) receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 20Dec2020 11:45 at single dose at left arm for immunization. Medical history included known allergies: sulfa. Concomitant medication in two weeks included bupropion hydrochloride (WELLBUTRIN). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Immediately following vaccination, patient whole left arm was numb, the numbness slightly improved, but then only palms of hands were numb. Later that night, the numbness and itching happened also to the soles of feet, hands also became red and itchy, and then patient got hives that lasted 48 hours, but nightly hives after that, the hives would resolve after taking PO (per oral) diphenhydramine hydrochloride (BENADRYL), and then would come back again that night. Patient was still having them. The adverse events resulted in emergency room/department or urgent care. Outcome of events was reported as recovered/resolved with sequel. The report is considered as non-serious. Information on the lot/batch number has been requested.
31 2021-01-05 vaccination site swelling, vaccination site pain, vaccination site warmth 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful.... Read more
8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0140), intramuscular in the right arm on 21Dec2020 15:00 at a single dose for COVID-19 immunization at the age of 31 years old at the workplace clinic. Medical history included asthma and seasonal allergies. Concomitant medications included fluticasone nasal spray, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), salbutamol sulfate (ALBUTEROL), zinc and unspecified multivitamin. On 29Dec2020 16:00, 8 days after the vaccine, the patient had swelling at the injection site on her right arm, it is hot and painful. Also, the patient had pain in right fingers and lymph pain in axillary region. Outcome of the events was unknown. No treatment was given for the events. The events were assessed as non-serious.
31 2021-01-05 itchy skin Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is b... Read more
Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; felt bad/did not feel right all day; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; there is a lot of paranoia; This is a spontaneous report received from a contactable consumer (who is also the patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 28Dec2020, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated she got the first dose of the Pfizer Covid vaccine on Monday, 28Dec2020. She mentioned that she read the list of side effects and all the print outs and stated her events were not on there. She wanted to make sure and stated maybe it was not even from the vaccine. She reported she just came from the hair dresser, had hair colored before many times, but today (30Dec2020), when she put the dye on her hair, she broke out with what felt like a million bugs on her head and face, stated it is burning and itching, maybe it is her imagination. She knows there is a lot of paranoia. She reported that she has had hair colored before and this has never happened, it occurred during hair coloring treatment. She also mentioned that on 30Dec2020 (also reported as "yesterday", pending clarification), she felt dizzy and nauseous; on 29Dec2020 (reported as "yesterday"), she felt bad and did not feel right all day, but says she knows those were listed symptoms. The outcome of the events dizziness, nausea, burning sensation and pruritus was recovering; the outcome of events paranoia and feeling abnormal was unknown.
31 2021-01-05 itchy skin, rash with redness Ten minutes after Covid vaccine begin to feel "itchy" , lips tingling/itchy; dry heaving, chest pres... Read more
Ten minutes after Covid vaccine begin to feel "itchy" , lips tingling/itchy; dry heaving, chest pressure.E rythematous rash on face. Evidence of excoriation on neck and upper chest. No shortness of breath Rapid response team called and transported to ED. Received epinephrine, Benadryl, Pepcid, Zofran and Solu-Medrol. Discharged at 8:20 PM home. E Today she is experiencing: itching all over, lips tingling, legs and arms feel very heavy, weak. Will follow up with her healthcare provider MD @ Hospital.
31 2021-01-06 skin burning sensation Body aches, chills, headache, skin burning. Took Tylenol.
31 2021-01-06 itchy skin, injection site swelling, injection site pain Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache... Read more
Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache, chills Day 3: fatigue, raised area, itching in the arm, pain in arm Day 4: nausea, diarrhea, itching in arm, raised bump at injection site, itchy throat, cough, runny nose
31 2021-01-06 skin discolouration Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills N... Read more
Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills Narrative
31 2021-01-06 itchy skin Facial flushing with extension to anterior neck approximately 10 minutes status post vaccination. Mi... Read more
Facial flushing with extension to anterior neck approximately 10 minutes status post vaccination. Mild pruritis forehead reported. Denies SOB and other symptoms. Epinephrine x 1 administered 15 minutes after vaccination left thigh. After epinephrine felt better and transported to ER via ambulance without incidence.
31 2021-01-06 injection site redness, injection site warmth, injection site pruritus, injection site rash Had initially had heaviness in chest but tolerable. Injection site was red with bump for 2 days, the... Read more
Had initially had heaviness in chest but tolerable. Injection site was red with bump for 2 days, then resolved. evening of 1/6/21 itchiness returned to injection site and now today 1/7/21 injection site has a warm, red itchy area that is 50 mm in diamter.
31 2021-01-06 injection site hardening, injection site swelling, injection site pain Left axillary swelling developed on day 2 after vaccination. Measuring approximately 6 cm x 6 cm. Si... Read more
Left axillary swelling developed on day 2 after vaccination. Measuring approximately 6 cm x 6 cm. Site is visibly mildly swollen. Feels firm. Tender to palpation.
31 2021-01-06 injection site pain Low back pain Bodyache Injection site pain
31 2021-01-06 redness, itchy skin, injection site swelling, injection site nodule Patient reported to COVID Vaccine administration site two days post vaccination for Pfizer COVID vac... Read more
Patient reported to COVID Vaccine administration site two days post vaccination for Pfizer COVID vaccine to report an itchy red, raised bump/hard nodule at the vaccine site. Vitals were as follows: BP 137/74 O2 Sat on RA 99.9% HR 93 Physician evaluated the patient and instructed to apply compress and report to ER if symptoms worsen.
31 2021-01-06 injection site pain Significant arm pain at site of injection starting at 5pm. Then developed vague aching throughout lo... Read more
Significant arm pain at site of injection starting at 5pm. Then developed vague aching throughout lower back, shoulder, and hips. Progressed to shooting pains (mild) into both legs and down both arms into fingers and toes. muscle aches and pains persisted until 4pm on 1/7. Also developed inflamed lymph node under left arm pit.
31 2021-01-06 itchy skin, hives, rash UrticariaPruritus HIVES ON ARM AND BACK Narrative:
31 2021-01-07 rash 2:45 pm - 10 minutes after receiving vaccine pt reports throat tightness and sensation of lump in th... Read more
2:45 pm - 10 minutes after receiving vaccine pt reports throat tightness and sensation of lump in throat, and rash to face and chest 2:50 Pm pt evaluated by EMS and transported to Hospital pt reports is 10 weeks pregnant
31 2021-01-07 hives, itchy skin Approximately 18 minutes post injection, patient experienced itching and whelps on opposite limb as ... Read more
Approximately 18 minutes post injection, patient experienced itching and whelps on opposite limb as injection site. Diphenhydramine 25 mg chewable tablets given. Itching continued into legs and skin above lips. Prednisolone 40 mg liquid given. After 10 minutes, itching and whelps improved. Patient monitored for a total of 1 hr post injection.
31 2021-01-07 vaccination site pain Extreme pain in vaccine area for 72 hours post shot/ dull ache; Could not perform daily activities; ... Read more
Extreme pain in vaccine area for 72 hours post shot/ dull ache; Could not perform daily activities; This is a spontaneous report from a contactable other healthcare professional. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899;expiry date: unknown) via an unspecified route of administration (arm left), on 29Dec2020 at 15:30, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medication included an unspecified birth control. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 29Dec2020, at 18:00, the patient experienced extreme pain in vaccine area for 72 hours post shot. The patient could not perform daily activities. Post 72 hours extreme pain subsided and became a dull ache for 2 days. The patient received pain medication as treatment for extreme pain. Outcome of the events "extreme pain in vaccine area for 72 hours post shot/ dull ache" was recovering, while for the other event was unknown.
31 2021-01-07 rash Eye swelling, lip swelling and rash.
31 2021-01-07 injection site pain First dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 1... Read more
First dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 Fatigue, malaise, soreness at injection site. 12/31-1/4 Migraines, increased fatigue and malaise, increased lightheadedness, body aches, intermittent dry cough. 1/5-1/8 decreased body aches, decreased fatigue, sustained lightheadedness.
31 2021-01-07 vaccination site redness, vaccination site pain Headache 24 hours after but nothing; uncontrollable/teeth chattering; chills; Fever; all over muscle... Read more
Headache 24 hours after but nothing; uncontrollable/teeth chattering; chills; Fever; all over muscle aches; Injection site is sore and surrounding area is red; Injection site is sore and surrounding area is red; This is a spontaneous report from a contactable Other HCP. This 31-year-old female Other HCP (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on 30Dec2020 at 11:00 AM (at the age of 31-years) as single dose, Intramuscular into right arm for immunization. Medical history included COVID-19 virus test positive from 30Nov2020 to an unspecified date. Allergies were reported as none. Concomitant medications included magnesium citrate, magnesium oxide, riboflavin, tanacetum parthenium (MIGRELIEF) and curcuma longa rhizome, piper nigrum fruit (TURMERIC +). On 31Dec2020 (00:45), patient experienced headache 24 hours after vaccine but nothing to keep her from my normal activities. About 36-40 hours post vaccine on 01Jan2021 patient awoke with uncontrollable/teeth chattering chills with 101 Fahrenheit (F) fever and muscle aches. Fever broke after taking Tylenol severe. Temp at 5:30AM back down to 98.5F. Temp creeping up again to 99.5F at 11AM. Injection site is sore and surrounding area is red on 01Jan2021. The patient is experiencing all over muscle aches. The patient received treatment and controlled the fever with Tylenol. Lab data included body temperature 101, 98.5, 99.5 Fahrenheit all in Jan2021. Events 'Headache', 'teeth chattering', 'chills', 'fever', 'muscle pain', 'muscle pain' and 'Injection site is sore and surrounding area is red' were recovering.
31 2021-01-07 vaccination site pain Muscle aches; joint pain; injection site pain; This is a spontaneous report from a non-contactable n... Read more
Muscle aches; joint pain; injection site pain; This is a spontaneous report from a non-contactable nurse reported for herself. A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date unknown), via an unspecified route of administration on left arm 05:30 PM on 04Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications include escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN). The patient previously took the first dose of bnt162b2 (lot number: EH9899) via an unspecified route of administration on arm left on 14Dec2020 at single dose for covid-19 immunisation. The patient experienced muscle aches, joint pain, injection site pain on 05Jan2021 04:00 AM after the second vaccine administrated, with outcome recovered. The patient received treatment for the events with Ibuprofen. No follow-up attempts are possible. No further information is expected.
31 2021-01-07 rash, vaccination site itchiness, vaccination site redness On day 6, developed large, urticarial hives at injection site associated with significant burning, a... Read more
On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; Developed diffuse, pinpoint, non-pruritic, flat rash to trunk.; redness, and itching at injection site; redness, and itching at injection site; Developed mild hives at injection site/large, urticarial hives at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscular from 28Dec2020 08:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took cephalosporin and experienced allergies. The patient developed mild hives, redness, and itching at injection site on days 2 and 3. Symptoms resolved entirely on days 4 and 5. On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity. On 30Dec2020, she developed diffuse, pinpoint, non-pruritic, flat rash to trunk. Rash resolved with Benadryl. Extremity pain and burning persists despite Benadryl. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within 2 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did receive treatment for the events which included Benadryl and Pepcid. The events resulted in emergency room/department or urgent care. The outcome of the events "Developed mild hives at injection site/large, urticarial hives at injection site", "On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity" was unknown; for events "Paraesthesia" and "pain in extremity" was not recovered; and for the other events was recovered on an unspecified date.
31 2021-01-07 itchy skin, hives UrticariaPruritus sweating, fatique, lymph node swelling Narrative:
31 2021-01-07 redness diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness ... Read more
diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital, experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-01-07 sensitive skin hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/p... Read more
hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/pains.
31 2021-01-07 injection site pain, injection site redness, injection site bruising, injection site swelling injection given proximal to acromion process resulting in pain , hematoma, and erythema at injection... Read more
injection given proximal to acromion process resulting in pain , hematoma, and erythema at injection site. Pain started within an hour of injection; bruising observed the next day after removal of band aide; redness started on day 2 post injection. Ice was applied to injection site reduced redness and swelling.
31 2021-01-07 vaccination site redness, vaccination site warmth raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my ... Read more
raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination. Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
31 2021-01-08 injection site swelling, injection site redness Dizziness, Fever, fatigue, redness and swelling at injection site, Narrative: off work x 1 day;
31 2021-01-08 skin warm Side effects started 12 hours after 2nd dose of vaccine (lot EL1284). I got chills, body aches, naus... Read more
Side effects started 12 hours after 2nd dose of vaccine (lot EL1284). I got chills, body aches, nausea, enlarged and swollen lymph node under left armpit that is warm to the touch and hurts.
31 2021-01-09 hives, itchy skin Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feel... Read more
Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feeling hot, flushed, and tachycardia briefly around 5 min. 10 min developed a pressure in my chest, and dizziness. Within 20 min, developed itching, flushing and hives specifically on left arm, hand, and across chest. Within 45 min, both ears and forehead covered with hives. Hospital staff made me go to ED. Within ED hives continued to progress across the chest and bilateral arms and wrists. Received 50mg of Benadryl, and 40mg of prednisone. Symptoms improved but did not resolved. 3 hrs following vaccine, bilateral lip swelling. Took 40mg of percribed pred and 25mg of Benadryl again around 4pm. Within 12 hrs, significant diarrhea. Hives resurfaced on face, bilateral wrists, arms, and ears around 645 on the 12/29. Fever 100.3 noted on 12/29-12/30. Intermitted hives, and lip swelling remained until 1/1. Nausea diarrhea and body aches until 1/2.
31 2021-01-09 injection site pain Right after the second dose less than 2 minutes my heart rate began to spike. I could feel my heart ... Read more
Right after the second dose less than 2 minutes my heart rate began to spike. I could feel my heart pumping fast. I couldn?t sit due to this so I began pacing the room. I didn?t know this was a side affect so I thought I was over thinking the second dose. I attributed this to all the worry and doubt the media and people around me try pumping in your head. I thought I was having a panic attack. I didn?t alert any of the medical team there because again, I thought I was over thinking it. A few hours later my heart rate had gone down. My Apple Watch helped me monitor this. The next day I felt pain at the injection site, not my normal self, groggy. Slightly feverish and chilled. I work in a cold environment so I couldn?t quite tell if the chilled feeling was a side effect, or the room. Later that evening around 9pm things took a turn. I began running a low grade fever and was shaking from being so cold. About another hour late my fever was up to 101 and I was still shaking from being so cold. I took about 600mg of ibuprofen. I couldn?t sleep, tossed and turned. Probably another hour later my temperature was 102, still shaking uncontrollably. Covered in about 5 blankets I kept waiting it out. And I?d say around 2-3am I could feel my fever breaking. By late morning my temp was back to normal but I felt achy still. Tired, sore. Definitely sore at my injection site. And I don?t know if this is worth mentioning or not but just haven?t been able to shake that panic attack feeling. Like a worry or a dread over me. I just don?t feel as clear-headed as I did before. This is my biggest concern. Just don?t feel myself yet.
31 2021-01-10 injection site pain 2nd dose: Sore at site of injection left arm 5-6 hrs after injection. 6 AM body aches, chills and di... Read more
2nd dose: Sore at site of injection left arm 5-6 hrs after injection. 6 AM body aches, chills and dizziness, symptoms are resolving at time of reporting 1 dose: only soreness at site of injection few hrs
31 2021-01-10 injection site pain I got fatigue a few hours after vaccine and resolved after a nap of 3 hours. My arm also still has ... Read more
I got fatigue a few hours after vaccine and resolved after a nap of 3 hours. My arm also still has soreness at the injection sight when touch and area around my underarm hurts with movement.
31 2021-01-10 hives, redness, itchy skin Itch, redness and hives
31 2021-01-10 injection site swelling, injection site pruritus, injection site pain, redness Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at t... Read more
Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(no pain noted but area is itchy to patient.) area affected was directly around the injection site (left upper arm) spreading out about 2 inches around in all directions. Within about 5 minutes, area looks normal (no longer swollen or red) and was much less itchy for pt. Pt plans on going home.  Actions Taken: VS taken and WNL. Disposition: Patient declined ED visit
31 2021-01-10 injection site pain Received second Pfizer covid vaccine. Felt extremely fatigue, joint pain, and pain in the injection ... Read more
Received second Pfizer covid vaccine. Felt extremely fatigue, joint pain, and pain in the injection site Friday night at work. Saturday night felt extremely fatigue.
31 2021-01-11 injection site pain All symptoms started around 12 hours after the vaccine and peaked at 18 hours: Fever 103f, body ache... Read more
All symptoms started around 12 hours after the vaccine and peaked at 18 hours: Fever 103f, body aches, malaise, severe headache, injection site pain, loss of appetite
31 2021-01-11 rash Recipient reported a sore throat and an upper body rash on the neck area and parts of the face that ... Read more
Recipient reported a sore throat and an upper body rash on the neck area and parts of the face that eventually faded.
31 2021-01-11 hives Widespread Hives
31 2021-01-11 vaccination site redness, vaccination site warmth a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site;... Read more
a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site; a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site; a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unknown route of administration in left arm on 03Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included birth control. No known allergies. Concomitant medications included drospirenone, ethinylestradiol (OCELLA) for birth control, escitalopram oxalate (LEXAPRO). Patient had a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site. She noticed it about 4-5 hours after the injection and it hadn't changed since. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the events was not recovered. Information about Lot/batch number has been requested.
31 2021-01-11 rash with redness, itchy rash a red looking rash that's itchy; a red looking rash that's itchy; This is a spontaneous report from ... Read more
a red looking rash that's itchy; a red looking rash that's itchy; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0140 and expiry date: Mar2021, via an unspecified route of administration in left arm from 23Dec2020 to 23Dec2020 as single dose (first dose) for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated she noticed the day after getting the COVID vaccine, 24Dec2020 that morning when she woke up between 9am to 10am that she had this red looking rash that it is itchy. The person who gave her the shot placed a band-aid on the site of injection. At first caller thought the person who gave her the injection missed the site where it was injected where placing the band-aid. However, this was a big red circle. The circle was bigger than a quarter. It is still itchy. This is located on her left arm. She stated she was hoping it would just go away on its own. No additional details provided. She is due to receive the second dose on 13Jan2021 or 14Jan2021 depending on when there is availability. The patient is about 130 pounds give or take. The outcome of the event was not recovered.
31 2021-01-12 hives After my first dose, the only symptom I had was soreness at the injection site lasting 1 day. 12 hou... Read more
After my first dose, the only symptom I had was soreness at the injection site lasting 1 day. 12 hours after my second vaccine, I developed muscle aches and chills that were gone the following morning when I woke up. 3 days after receiving my second dose, I developed hives and swelling on my entire body that progressed over 2 days. I also started to have some swelling in my throat by 4 days after the second dose and ended up going to immediate care for a steroid injection which began to provide relief by the next morning.
31 2021-01-12 rash DEVELOPED RASH TO NECK AND ARM LASTING 30 MINUTES. RECEIVED 25MG DIPHENHYDRAMINE BY MOUTH AT 3:30PM.... Read more
DEVELOPED RASH TO NECK AND ARM LASTING 30 MINUTES. RECEIVED 25MG DIPHENHYDRAMINE BY MOUTH AT 3:30PM. RASH RESOLVED IN 30 MINUTES
31 2021-01-12 pain of skin Fatigue, fever, chills, body aches, joint pain, skin hurting
31 2021-01-12 rash papular, rash with redness, rash, itchy rash I developed a raised red rash that started under my chin and has spread up my face, all down my neck... Read more
I developed a raised red rash that started under my chin and has spread up my face, all down my neck, around my ears, down my chest, and in my groin. The rash burns and itches.
31 2021-01-12 injection site pain Pain at injection site, Arm soreness starting at time of injection , elevated temp 99F with mild ... Read more
Pain at injection site, Arm soreness starting at time of injection , elevated temp 99F with mild chills, fatigue and malaise starting the following morning lasting about 8 hours.
31 2021-01-12 skin warm, redness Patient had sudden onset of flushing/erythema of skin (no pruritus, but warm to touch), diaphoresis,... Read more
Patient had sudden onset of flushing/erythema of skin (no pruritus, but warm to touch), diaphoresis, and itchy throat. She denies shortness of breath or any respiratory problems. Symptoms started 20 min prior to arrival at the Emergency Department. When the patient arrived at the ED, all of her signs and symptoms had started to subside.
31 2021-01-12 injection site reaction, injection site warmth, injection site swelling, injection site redness Patient started to have a local injection site reaction on 1/10/21 at around 9:10am. The injection s... Read more
Patient started to have a local injection site reaction on 1/10/21 at around 9:10am. The injection site had some redness and swelling. By the afternoon on 1/10/21 the red and swelling increased and by 1/12/21 the redness was the size of a half dollar and swelling just beyond the redness. The area is warm to touch. Pt also had symptoms of nausea, fatigue, and muscle pain. Pt was instructed to take Zyrtec BID & pepcid. When I talked to the patient on 1/13/2021, the injection site remains the same and still feels nauseated.
31 2021-01-12 rash RASH ON ARMS AND LEGS THAT WHEN AWAY WITH BENADRLY , RETURNED THE NEXT DAY AND PERSISTED., SEEN IN e... Read more
RASH ON ARMS AND LEGS THAT WHEN AWAY WITH BENADRLY , RETURNED THE NEXT DAY AND PERSISTED., SEEN IN ed EMPLOYEE HAS PURRITIS IN THROAT, THRATED WITH BENADRLY.
31 2021-01-12 injection site pain Soreness of point of entry of shot that lasted 30hrs.
31 2021-01-12 redness, pain of skin, skin warm, rash papular Spot on arm, just below injection site. Red, warm, tender, round with irregular border. In first 48h... Read more
Spot on arm, just below injection site. Red, warm, tender, round with irregular border. In first 48hrs after second vaccine, sane arm was sore and stiff. No other side effects/reactions noticed until red spot.
31 2021-01-12 injection site pain Took Advil and symptoms were relieved. Chills, fever, headache, injection site pain, malaise, new o... Read more
Took Advil and symptoms were relieved. Chills, fever, headache, injection site pain, malaise, new or worsened joint and muscle pain
31 2021-01-12 rash rash on neck
31 2021-01-12 itchy skin vaccine recipient had diffuse itching and burning feeling after her vaccine. reported she has had t... Read more
vaccine recipient had diffuse itching and burning feeling after her vaccine. reported she has had this with another medicine, penicillin. continued to itch all over so administered 25 mg of Bendaryl and 20 mg of Pepcid to treat symptoms.
31 2021-01-13 skin burning sensation, sensitive skin 01/08/21 received the vaccination, am of 01/09/21 woke up with headache, body aches, chills, took Ex... Read more
01/08/21 received the vaccination, am of 01/09/21 woke up with headache, body aches, chills, took Excedrin and ibuprofen, worked all day and by the end of the shift started feeling worse. Symptoms to include : shaky, felt like she was freezing to death but no fever at this point, skin felt like it was on fire, Around 8:00pm temp of 100PO at this time took 1000mg Tylenol and when she had got the shower skin was very sensitive to the water and felt like it was hot, but the water was not, by 10:00 pm temp of 103, felt shaky, achy all over, dizziness/nausea, muscle weakness, fatigue. Went to bed that night, had night sweats during the night. 01/10/21 got up around 4:30am to get ready for work, continued with severe muscle weakness, shaky, headache, got in shower and fell from being so weak and tired. Gradually through the day got better, had went back to bed that morning and slept almost all day and by 3:00pm -4:00pm was feeling much better.
31 2021-01-13 vaccination site pain Fever 100; injection site pain; Moderate body aches; Chills; This is a spontaneous report from a con... Read more
Fever 100; injection site pain; Moderate body aches; Chills; This is a spontaneous report from a contactable nurse (patient). A 31-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 07Jan2021 10:30 at single dose in left arm for covid-19 immunization. Medical history included asthma and depression. The patient had no allergies to medications, food, or other products. Concomitant medications the patient received within 2 weeks of vaccination included celecoxib (CELEXA) and bupropion. The patient previously received her first dose of bnt162b2 on 18Dec2020 15:00 at the age of 31-years in her left arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced moderate injection site pain, moderate body aches, chills and fever 100 on 07Jan2021 22:00. The patient was not received any treatments for the adverse events. The outcome of the events was not recovered. Information about lot/batch number has been requested.
31 2021-01-13 injection site pain TWO DAYS OF SINTOMOS,PAIN INJECTION SITE, HEADACHE,MUSCULAR PAIN,FEVER,ABDOMINAL PAIN, DIARREA,SUETI... Read more
TWO DAYS OF SINTOMOS,PAIN INJECTION SITE, HEADACHE,MUSCULAR PAIN,FEVER,ABDOMINAL PAIN, DIARREA,SUETING AND INFLAMATION OF THE GANGLIOS.
31 2021-01-14 rash 1/13 got vaccine at 12 noon-about 12 hours later ?Middle of the night woke up with sweats, fever, he... Read more
1/13 got vaccine at 12 noon-about 12 hours later ?Middle of the night woke up with sweats, fever, headache, nausea, body aches, chills, joint pain and rash on right arm. Symptoms continued all through the day and next night. Fever resolved 1/15 in the am with highest fever that day being 99, muscle aches still persisted and headache persisted through the day. This day the headache was the worst symptom and it was very severe. The new thing that started on this second day post vaccination was nausea and abdominal pain which was not present as badly the day after.
31 2021-01-14 injection site pain At the time of the second vaccine I was 14 weeks and 5 days into my first pregnancy. The estimated d... Read more
At the time of the second vaccine I was 14 weeks and 5 days into my first pregnancy. The estimated date of delivery is July 08,2021. The only side effect I experienced was soreness at the site of injection.
31 2021-01-14 vaccination site pain Extreme pain in arm where injection was placed; Numbness in hands; Tingling sharp pain throughout en... Read more
Extreme pain in arm where injection was placed; Numbness in hands; Tingling sharp pain throughout entire arm and under arm; Tingling sharp pain throughout entire arm and under arm; Weakness in arm that injection was placed.; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021 at 11:00 AM as a single dose in the right arm for COVID-19 immunization at hospital facility. Relevant medical history was none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL). The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on unknown date via unknown route of administration for COVID-19 immunization. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 08:00 PM, after the second dose, the patient experienced extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. No treatment was received for the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. The outcome of the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed was unknown. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2 dose 1, was not provided and will be requested during follow up.
31 2021-01-14 vaccination site swelling, vaccination site pain I have swelling and pain in my underarm on the same side as my shot. My arm is still sore. But the s... Read more
I have swelling and pain in my underarm on the same side as my shot. My arm is still sore. But the swelling has not decreased . Started Saturday morning after my 2nd vaccine dose Friday night.; I have swelling and pain in my underarm on the same side as my shot. My arm is still sore. But the swelling has not decreased . Started Saturday morning after my 2nd vaccine dose Friday night.; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on left arm on 08Jan2021 19:00 at a single dose for Covid-19 immunization. Medical history included lymphoma, and red food coloring allergy. The patient received her first dose of BNT162B2 on 22Dec2020. The patient's concomitant medications were not reported. The patient reported she had swelling and pain in her underarm on the same side as her shot. Her arm was still sore, and the swelling has not decreased. It started Saturday morning (09Jan2021 at 6am) after her 2nd vaccine dose on Friday night. It was unknown if patient received any treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered. Information about Lot/Batch number is requested.
31 2021-01-14 injection site pain Injection site pain appeared right after vaccine administration. Pain became more severe the next da... Read more
Injection site pain appeared right after vaccine administration. Pain became more severe the next day and it lasted for a total of three days(1/8~1/10) The next day of vaccination(1/9), I have symptoms of low grade fever, chills, fatigue, mild body aches, headache, vomiting feeling. However, these symptoms only lasted for one day.
31 2021-01-14 injection site swelling, injection site warmth, injection site pruritus Swelling, itching, hot to the touch at left delt (injection site.) Delayed onset 10 days.
31 2021-01-15 injection site redness, injection site warmth, injection site pruritus, injection site mass Bright red circle, 2? by 2.5?. Warm to touch. Large lump under skin. Itchy. All lasted roughly 2 d... Read more
Bright red circle, 2? by 2.5?. Warm to touch. Large lump under skin. Itchy. All lasted roughly 2 days before got better. Used Benadryl cooling gel to soothe.
31 2021-01-16 itchy skin, hives, rash 1st day: fatigue, intermittent joint pain/urticaria. 2nd day: generalized rash, pruritus - have take... Read more
1st day: fatigue, intermittent joint pain/urticaria. 2nd day: generalized rash, pruritus - have taken benadryl
31 2021-01-16 itchy skin Itchy skin Nausea Bad Headache Severe L arm pain
31 2021-01-17 vaccination site pain, vaccination site warmth, vaccination site redness, vaccination site swelling Swelling at the injection site; Pain at the injection site; burning upon administration; Redness at ... Read more
Swelling at the injection site; Pain at the injection site; burning upon administration; Redness at the injection site; Warmth at the injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1284), via an unspecified route of administration in left arm, on 04Jan2021 at 12:00, at a single dose, COVID-19 immunization. The patient's medical history included polycystic ovarian syndrome (PCOS) and fish allergy. The patient's concomitant medications included Curcuma longa (TURMERIC), probiotics, and unspecified multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 04Jan2021 at 12:00 PM, the patient experienced swelling, pain, redness, and warmth at the injection site lasting for 3 days. It was burning upon administration. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 07Jan2021. No follow-up attempts are possible. No further information is expected.
31 2021-01-17 itchy skin, vaccination site pain, rash felt a little bit warm and itchy in her chest area; felt a little bit warm and itchy in her chest ar... Read more
felt a little bit warm and itchy in her chest area; felt a little bit warm and itchy in her chest area; Rash/ rashes in her neck and chest area; swollen lymph node in armpit area; soreness/pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: Mar2021), intramuscular in the left arm on 07Jan2021 at 0.3 mL, single dose for COVID-19 immunization. Medical history included testing positive for COVID in Apr2020. There were no concomitant medications. The patient previously took flu shot and experienced soreness. The patient did not receive any vaccination within 4 weeks prior to the COVID vaccine. The patient called in regards to Pfizer COVID Vaccine. She received her first vaccine last Thursday, 07Jan2021. She was not sure if she can report this as a side effect, but she had some rashes appear just today (11Jan2021), at midnight, in her neck and chest area. The rashes were going away, but she still has some itching. She also stated that she took some over-the-counter diphenhydramine (BENADRYL, UPC: 1254717031, lot number: PJF044, expiration date: Jun2021) tablets to relieve the symptoms. She explained that she started to experience soreness/ pain at the injection site a few hours after receiving the COVID-19 vaccine. The pain in her arm has already went away. She noticed a swollen lymph in her armpit area on Friday morning, 08Jan2021 and it's still a little bit swollen. She didn't expect on getting a rash since she read symptoms only appear around 2-3 days only. Therefore, she is not sure if she can report this as a side effect because its been like 3 days already. She noticed the rash just today, at midnight. She stated that she is still itchy. She stated that there is just a little bit of itchiness in her neck. She felt a little bit warm and itchy in her chest area, at midnight (unspecified date), and she kept scratching. She knows she shouldn't have done that but it was itchy. The patient would consider these events to be non-serious. She did have some soreness with a flu shot before so it's not too serious. She explained she is a healthcare worker. She works in a nursing home facility and they asked if she wanted to receive the Covid-19 vaccine and she filled out the form. She also explained that she doesn't have any allergies to any medications. So, with the rashes that came, she is not really sure what is the cause of it. The events did not require a visit to the emergency room or physician office. She stated she wanted to report this information but she also needs advice on whether she needs to continue taking Benadryl. Her rash is improving, but she is still a little bit itchy. She doesn't have any shortness of breath or anything. It's not a major reaction, just a little bit of a rash/itchiness in her chest and neck area. The outcome of the event vaccination site pain was recovered on 10Jan2021, for lymphadenopathy and rash was recovering, for pruritus was not recovered and for feeling hot was unknown.
31 2021-01-17 hives following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covi... Read more
following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covid vaccine face flushing; increased HR about 45 mins. went away on its own; hours later left eye swollen; This is a spontaneous report from a contactable Nurse (patient). A 31-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Known allergies: Shellfish, IV contrast dye, Penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced after first dose of covid vaccine face flushing; increased hr about 45 mins. went away on its own since 06Jan2021 16:00; hours later left eye swollen on 06Jan2021; following day around 7pm lip swelling, tongue tingling, body hives, chills on 07Jan2021 19:00. The patient underwent lab tests and procedures which included heart rate: increased on Jan2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Steroids, IV fluids, Benadryl. No COVID prior vaccination. No COVID tested post vaccinate. This report was reported non-serious. The event outcome of increased hr about 45 mins. went away on its own was recovered on 06Jan2021 16:45, outcome of other events were not recovered.; Sender's Comments: Based on the compatible time association, the serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-01-18 itchy skin, hives Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine howev... Read more
Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine however did develop symptoms within one minute of completing a run. Developed b/l hand swelling and tingling, diffuse hives and itching, tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids, Benadryl and IV steroids. This is similar to previous reactions I have had to running previously. Symptoms resolved within one hour after treatment in ED.
31 2021-01-18 sensitive skin, redness Chest swelling on my right side started 12/27/2020 and I ended up having to go to the ER. Chest swel... Read more
Chest swelling on my right side started 12/27/2020 and I ended up having to go to the ER. Chest swelling, redness, and sensitive to touch on the right side of my chest. Met with a cardiologist on 1/6/2021 due to severe side effects of the vaccine and Dr. said I know have Costochondritis
31 2021-01-18 vaccination site pain Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6. Fever pos... Read more
Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6. Fever post Tylenol 100.8.; Racing heart rate recorded at 120 bpm; Severe chills; body ache; muscle and bone pain; muscle and bone pain; Shooting pains in various joints; Brief stomach pain; Sore axillary lymph node on side of injection arm; Sore arm at injection; dizziness; weakness; This is a spontaneous report from a non-contactable other HCP. A 31-year-old female patient received BNT162b2 (lot: EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. Medical history included covid (Previous covid was diagnosed with serology antibody test in doctors office. Not diagnosed with a covid test). The patient's concomitant medications were not reported. Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6 (Jan2021). Fever post Tylenol 100.8 (Jan2021). Racing heart rate recorded at 120 bpm (08Jan2021). Severe chills and body ache, including muscle and bone pain. Shooting pains in various joints. Brief stomach pain. Sore axillary lymph node on side of injection arm. Sore arm at injection site began 3/4 hours post injection (08Jan2021). All other symptoms began 11 hours post injection (08Jan2021). Continued dizziness and weakness 56 hours post injection (Jan2021). The patient was not pregnant at the time of vaccination. The outcome of the events was Resolved with Sequel in Jan2021. No follow-up attempts are possible. No further information is expected.
31 2021-01-18 injection site pain Injection site reaction - very sore, "cant move my arm. " Developed sx about 24* after vaccination:... Read more
Injection site reaction - very sore, "cant move my arm. " Developed sx about 24* after vaccination: fatigue, body aches, headache, LUNG PRESSURE. Progressively worsening today.
31 2021-01-18 hives Noticed I scratched my abdomen but did not know why on friday/sat ... woke up sunday morning and an... Read more
Noticed I scratched my abdomen but did not know why on friday/sat ... woke up sunday morning and and saw hives around neckline, over umbilical area and all over upper thighs. They have not gone away with cetirizine or benadryl 25 mg as of yet.
31 2021-01-18 vaccination site pain Pregnant at the time of vaccination; Pregnant at the time of vaccination; Pregnant at the time of va... Read more
Pregnant at the time of vaccination; Pregnant at the time of vaccination; Pregnant at the time of vaccination; bilateral nerve like pain; small headache; temp 100.3; enlarged axillary lymph nodes; pain in both shoulder joints; chest soreness; feel exhausted/feel tired; Braxton Hicks contractions; slight chills; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; arm pain radiates around seems like nerve like pain; This is a spontaneous report from a contactable other HCP. A 31-year-old female other HCP reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EKS730) into the left arm at single dose on 22Dec2020 at 05:30 PM and received the second dose of BNT162B2 (Lot number EKS730) into the left arm on 08Jan2021 at 08:00 AM at single dose for COVID-19 immunization. The patient is pregnant, last menstrual date 29Apr2020, gestational period 35 and estimated delivery date 07Feb2021. Concomitant drug included Prenatal vitamin. The patient reported that on 08Jan2021 she experienced injection site soreness at 20:00, the arm pain radiates around seems like nerve like pain with chest tightness. Temperature 97.7, she took Tylenol 1000 mg. On 09Jan2021 at 00:15 she had slight chills, at 01:20/01:30 chills, arm pain, chest more tight, Braxton Hicks contractions for about 1 hour, temperature 99.9, she took Tylenol 1000mg and went to sleep. At 08:00 she had no chills temperature 98.8, pain in both shoulder joints, chest soreness- feel exhausted. At 09:00 1000mg Tylenol, at 14:15 temperature 98.0, at 17:45 temperature 99.8, she took 750mg Tylenol. At 18:20 temperature 100.3, she took 250mg Tylenol, at 18:50 temperature 99.0 after shower, at 19:08 temp 98.8 and at 22:00 feeling slightly better, she had bilateral nerve like pain, chest pain, small headache. On 10Jan2021 at 02:45 temp 98.2 she took 1000mg Tylenol, at 09:00 temp 97.9, bilateral nerve like pain and enlarged axillary lymph nodes, chest sore, slight headache. At 17:00 temp 96.6 bilateral nerve/lymph node pain and felt tired. The patient did not have Covid prior vaccination and she was not Covid tested post vaccination. At the time of reporting the patient was recovering.
31 2021-01-18 hives shortness breath, chest pain and abdominal hives
31 2021-01-19 injection site swelling, injection site pain 2nd day after the vaccination, my left arm had a swollen bump below the injection site along with pa... Read more
2nd day after the vaccination, my left arm had a swollen bump below the injection site along with pain. I felt fatgued, slight fever, and body aches. I took an antihistamine for 5 days and the symptoms resolved itself.
31 2021-01-19 injection site pain, injection site swelling 6 DAYS OF SINTOMES ,PAIN INJECTION SITE,MUSCULAR PAIN, FEVER SWELLING ON SHOULDER AREA,LIMITED OF MO... Read more
6 DAYS OF SINTOMES ,PAIN INJECTION SITE,MUSCULAR PAIN, FEVER SWELLING ON SHOULDER AREA,LIMITED OF MOVEMENT ,LAST 3 DAYS SINTOMES MILD.
31 2021-01-19 itchy skin Approximately 8 hours after receiving the vaccine she began noticing itchy throat, eyes, ears, nasal... Read more
Approximately 8 hours after receiving the vaccine she began noticing itchy throat, eyes, ears, nasal congestion and sneezing. These symptoms lasted for about 48 hours.
31 2021-01-19 injection site pain Dose was not given, dripped down arm , was re-dosed. Patient was administered first dose, measured ... Read more
Dose was not given, dripped down arm , was re-dosed. Patient was administered first dose, measured to deltoid. Inserted needle and felt resistance when pushing in syringe, pulled out early, vaccine dripped down arm. Patient reported pain. Second dose was given by a different volunteer.
31 2021-01-19 injection site pain Localized, painful injection site reaction Fatigue Headache
31 2021-01-19 itchy skin Patient received her second Pfizer dose and began to complain of stomach cramps, feeling flushed and... Read more
Patient received her second Pfizer dose and began to complain of stomach cramps, feeling flushed and itchiness in her hands. Patient received 50mg of Benadryl IM and was transported to the hospital via ambulance.
31 2021-01-20 vaccination site pain Fatigue; Injection site pain; Runny nose; Cold-like symptoms; This is a spontaneous report from a co... Read more
Fatigue; Injection site pain; Runny nose; Cold-like symptoms; This is a spontaneous report from a contactable physician (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in left arm on 11Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient previously took codeine and amoxicillin and experienced allergy. The patient received multivitamins within 2 weeks of vaccination. On 12Jan2021, the patient experienced fatigue, injection site pain, runny nose and cold-like symptoms. The patient took OTC (over the counter) cold medication as treatment. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and had no congenital anomaly/birth defect.
31 2021-01-20 hives Hives; I used the Pfizer vaccine and had allergic reaction; This is a spontaneous report from a cont... Read more
Hives; I used the Pfizer vaccine and had allergic reaction; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: 21Dec2020) via an unspecified route of administration, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no concomitant medications. The patient stated that she received the Pfizer vaccine and she had an allergic reaction on an unspecified date in Dec2020. She was told by infectious disease to report it. She also reported that she got hives 3 days later. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient and the physician (whom she consulted) both considered a causal relationship between the events and the suspect drug.
31 2021-01-20 injection site pain Pain around injection site, fatigue, joint pain, body aches, chills. All lasted about 24 hours, but ... Read more
Pain around injection site, fatigue, joint pain, body aches, chills. All lasted about 24 hours, but fatigue lasted 48 hours.
31 2021-01-20 injection site hardening, injection site warmth, injection site mass, injection site pruritus, injection site redness Sore arm, but with this dose I had a red bump at injection site that started the size of a pea and a... Read more
Sore arm, but with this dose I had a red bump at injection site that started the size of a pea and as of the evening of 1/21/21 it is the size of a quarter, red hot and hard lump, it?s been itchy on and off since last night. I did not have anything other than a sore are with the first dose.
31 2021-01-20 itchy skin Within minutes and almost instantaneously, as the shot was being injected, my arm tingled. Then it ... Read more
Within minutes and almost instantaneously, as the shot was being injected, my arm tingled. Then it moved to my mouth and tongue. The roof of my mouth, and tongue became numb. I needed to think really hard how to swallow. It was like I could not figure out how to work that muscle. I took benadryl, to ease symptoms. It helped but did not take it away. Next day, mouth and tongue still numb, and my ears, eyes, nose and throat were itchy. My external skin was also itchy. My doctor put me on a steroid pack. 4 days later, I am doing much better still not 100% percent myself, but very close to being back to normal. Still have slight sensation in tongue.
31 2021-01-21 hives 48 hours post injection I began to experience hives everywhere on my body. Treatment included prescr... Read more
48 hours post injection I began to experience hives everywhere on my body. Treatment included prescription steroid creams, Zyrtec and Pepcid during the day and Benadryl at night. The reaction lasted approximately 10 days.
31 2021-01-21 hives Patient started to show signs of hives 30 mins after vaccination. Her symptomps started as mild hive... Read more
Patient started to show signs of hives 30 mins after vaccination. Her symptomps started as mild hive and persist and worsen. Advise patient to call PCP for treatment guidance and also advise to go to urgent care if her sympstoms keeps escalating.
31 2021-01-21 redness red swollen arm 10 days post vaccination. Initiated on antibiotics for concerns of developing cellul... Read more
red swollen arm 10 days post vaccination. Initiated on antibiotics for concerns of developing cellulitis.
31 2021-01-22 injection site redness, injection site rash, injection site warmth, rash About an hour after getting the shot, I did get extremely light headed and pulled my car over to get... Read more
About an hour after getting the shot, I did get extremely light headed and pulled my car over to get gas. I then noticed a rash all down the arm I got the vaccine and all over my chest and up my neck. I felt extremely hot. I got back in my car and sat at the gas station waiting for the lightheadedness to pass. I did call my GP at that time to make sure everything was OK. The nurse said that it sounds like a reaction but as long as I do not feel like I can not breathe or that my throat was swelling I should be ok. They advised me to eat something and also take benadryl once I got home. Rash stayed for a total of 2 days and today (3rd day) I only have a rash at the injection site. Its very red and hot to touch. Other symptoms I have/still have was very bad headache, fever (highest was 102.8 and today 3 days later is still over 101). Body aches, chills and the first 24 hours I felt like my internal organs were hot (sounds really weird!)
31 2021-01-22 injection site pain Fever of 101.3 taken temporally at 6pm. Did not check prior. Associated with arm soreness at site an... Read more
Fever of 101.3 taken temporally at 6pm. Did not check prior. Associated with arm soreness at site and fatigue all day
31 2021-01-23 rash, itchy skin, hives Full body burning itch all day on Jan 7 (starting at 930 am, vaccine received at 840 am) and Jan 8. ... Read more
Full body burning itch all day on Jan 7 (starting at 930 am, vaccine received at 840 am) and Jan 8. Developed upper body+face rash (noticed around 5 pm) and lower body hives/welts on Jan 8. Airway was not compromised during the whole event. Took Allegra BID, pepcid and singular QHS on Jan 7. Took Allegra and Pepcid BID, singularity QHS, and 50 mg benadryl on Jan 8. Discussed with immunologist, Dr. on Jan 8 to assess if ER trip required, determined it was not as symptoms mostly calmed by 11 pm/midnight on Jan 8-Jan 9.
31 2021-01-23 injection site pain Pain at site, fever up to 101.5, muscle aches, fatigue and chills
31 2021-01-24 redness 0800- BP166/114 HR 71 RR 20 OXYGEN 99% 0805 - BP 162/123 HR 78 RR 20 OXYGEN 98% 0810- BP 163/114 HR... Read more
0800- BP166/114 HR 71 RR 20 OXYGEN 99% 0805 - BP 162/123 HR 78 RR 20 OXYGEN 98% 0810- BP 163/114 HR 81 RR 20 OXYGEN 98% REDNESS ON CHEST, HEAVY FEELING IN CHEST, MILD HEADACHE, NO ANGIOEDEMA NOTED, NO RASH OR HIVES NOTED ON UPPER BODY, FACE OR NECK. UPPER LUNG SOUNDS MINIMALLY DECREASED-NO WHEEZING OR STRIDOR NOTED. BLOOD GLUCOSE 86.
31 2021-01-24 injection site rash, rash with redness, rash papular, skin warm, rash About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortne... Read more
About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortness of breath, body aches (extreme), joint pain especially in hips and knees, extreme fatigue, headaches, ears constantly rang. Rash on my arm where I received it went down to my elbow and up to my shoulder and on to my upper back, about 3 hours for it show up. It red, raised and bumpy and it felt hot. This lasted for 4 days. I was very pale and my eyes were sunken in. I literally felt like I was ran over by a vehicle. I was sleeping for about 15 hours a day. I kept getting chills then I profusely sweats then it switch to freezing cold and back and forth between the two. I took Tylenol and Benadryl to control symptoms but still felt miserable. The symptoms all stayed with me to the end. I still do not feel 100%, I am still having ringing of the ears, moderate body aches and headaches. Someone else said they still see the rash but I cannot really tell. I was also having trouble focusing for a few days after receiving the vaccine, I felt highly medicated not the fun high the bad high
31 2021-01-24 rash papular, rash, skin warm, injection site rash About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortne... Read more
About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortness of breath, body aches (extreme), joint pain especially in hips and knees, extreme fatigue, headaches, ears constantly rang. Rash on my arm where I received it went down to my elbow and up to my shoulder and on to my upper back, about 3 hours for it show up. It red, raised and bumpy and it felt hot. This lasted for 4 days. I was very pale and my eyes were sunken in. I literally felt like I was ran over by a vehicle. I was sleeping for about 15 hours a day. I kept getting chills then I profusely sweats then it switch to freezing cold and back and forth between the two. I took Tylenol and Benadryl to control symptoms but still felt miserable. The symptoms all stayed with me to the end. I still do not feel 100%, I am still having ringing of the ears, moderate body aches and headaches. Someone else said they still see the rash but I cannot really tell. I was also having trouble focusing for a few days after receiving the vaccine, I felt highly medicated not the fun high the bad high.
31 2021-01-24 rash, blister Bilateral petichial rash and blisters on dorsal aspect of hands between thumb and index finger
31 2021-01-24 itchy skin, rash Right after vaccination patient felt warm, rash started to appear and had intense itching about 10 m... Read more
Right after vaccination patient felt warm, rash started to appear and had intense itching about 10 minutes in to the event. She had premedicated with Benadryl 12.5mg along with Zyrtec. After itching started she was given an additional 12.5 mg of Benadryl. She was monitored for >30 minutes with improvement of symptoms. Rash still present but she said no longer has itching and that she knew her body well and that she was fine to leave. She stated that her mother was in the car waiting for her since she knew that she might have this type of reaction. We had a long discussion about going to the ER but she said she has Benadryl on her if needed and knew when she needed to get to an ER in terms of symptomatology. We also discussed option of having next dose with an allergist. She would like to call her allergist to discuss options but feels comfortable getting 2nd dose knowing how she reacted this time.
31 2021-01-25 injection site pain At the time of the second vaccination in the series, I was 17 weeks pregnant with an estimated date... Read more
At the time of the second vaccination in the series, I was 17 weeks pregnant with an estimated date of delivery of 6/21/21. I have had an uncomplicated pregnancy. About 12 hours after vaccination, I woke up in the middle of the night around 2:30am with chills and body aches and had a temperature of 100.7. I also had a headache, soreness at the site of injection, and a mild stomach ache. I took Tylenol every 6 hours starting 1 hour prior to vaccination and throughout the next day but continued to have temperatures ranging from 100.4 to 101.3 associated with chills, body aches, headache, and severe fatigue. I continued to have these symptoms until about 9pm that night. Once the fever broke, the majority of symptoms subsided, but I did continue to have a daily headache for about one week after the vaccine.
31 2021-01-25 hives, injection site pruritus, redness, itchy skin Injection site immediately felt severe itchy following injection but diminished after approx. 30-45 ... Read more
Injection site immediately felt severe itchy following injection but diminished after approx. 30-45 minutes. I then felt fine until exactly 3:00 pm (approx. 3 hours following injection). I stood up and immediately felt like passing out. I had excruciating cramping throughout my legs and horrible joint pain in my knees. By 3:30 I had hives covering my right hand- my hand was also very red and swollen and had severe itching/burning. By now I also had horrific joint and muscle pains all over my entire body and the leg cramping was even worse. the hives responded well two doses of Benadryl and the muscle aches somewhat improved with rotation of ibuprofen and Tylenol. By 5:00 am the following day, the joint and muscle pains were worse. My entire body felt like it was on fire and I had excruciating pain in my throat. It was difficult to speak or swallow and I could feel my throat swollen on the inside. My neck was also slightly swollen and the lymph nodes on the left side of my neck were in horrific pain but not swollen. I continued doses of Benadryl, ibuprofen and Tylenol all day and night and slept most of the time. By Sunday Morning, my throat felt even worse and I had 100 degree fever and continued body aches and joint pain. I was seen at a local urgent care who ran various tests (see below) that were negative and advised me to treat as if it were an allergic reaction and go to ER if I got any worse. Fever and pain improved by Monday and by Tuesday I was able to return to work but with significant fatigue and continued pain in my legs. I continued to improve throughout the week. Now the following week I overall feel back to normal other than I have continued leg pain, esp. in my knees by the end of the day.
31 2021-01-25 injection site swelling, injection site redness, injection site warmth, itchy skin, hives, injection site inflammation, injection site pain No symptoms at time of dose, was observed for 15 mins for safety. Reactions began 2 hrs afterward, a... Read more
No symptoms at time of dose, was observed for 15 mins for safety. Reactions began 2 hrs afterward, at home. Migraine, extreme fatigue, fever of 100.1 lasted from Friday 1/22 to Monday 1/25 between doses of Advil. Saturday 1/23, redness, swelling, pain, hot at injection site growing from golf ball size to softball size by Sunday morning. Began spreading inflammation around shoulder and inside arm. Slight hives visible Monday 1/25. Itching present.
31 2021-01-25 rash Rash / Diarrhea / CNS depression
31 2021-01-25 itchy skin increased appetite; Hot flashes; itching; This is a spontaneous report from a contactable consumer (... Read more
increased appetite; Hot flashes; itching; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient (non-pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: El3302), via an unspecified route of administration on 11Jan2021 18:45 at single dose on left arm for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced increased appetite, hot flashes and itching, all on 11Jan2021 20:00 with outcome of not recovered. No treatment was received for the events. No COVID prior vaccination. No COVID tested post vaccination. No COVID tested post vaccination.
31 2021-01-26 redness, itchy skin Itching; redness; This is a spontaneous report from a contactable other healthcare professional (pat... Read more
Itching; redness; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. Medical history was reported as none. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. She has no known allergies. The patient's concomitant medications were not reported. No other vaccines in four weeks prior to COVID vaccine. No other medication in two weeks. On 10Jan2021, the patient experienced itching and redness. Benadryl was given as treatment for the events. The events resulted in emergency room/department or urgent care. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. Information on the lot/batch number has been requested.
31 2021-01-26 injection site pain Patient received initial COVID-19 vaccine on 1/16/2021. Experienced injection site soreness and a l... Read more
Patient received initial COVID-19 vaccine on 1/16/2021. Experienced injection site soreness and a little fever lasting 48 hours. On 1/19/2021, patient developed severe sore throat/odynophagia. Went to an urgent care, and strep throat screen and COVID test and both resulted negative. Odynophagia continued, painful to swallow food/liquids. Never developed tongue or lip swelling. Due to ongoing fevers, patient admitted to hospital for ulcerative pharyngitis
31 2021-01-26 injection site pain Upset stomach resulting in three consecutive trips to the bathroom (diarrhea) over about a 15 minute... Read more
Upset stomach resulting in three consecutive trips to the bathroom (diarrhea) over about a 15 minute time frame. Upper left arm muscle pain - similar to right arm injection site. Felt like there was a lump in my throat for awhile making it very slightly difficult to breathe.
31 2021-01-26 hives Uticaria
31 2021-01-26 itchy skin, injection site pruritus Within thirty minutes of administration I started feeling itchy around injection site then all over ... Read more
Within thirty minutes of administration I started feeling itchy around injection site then all over my entire body. I stated to have some facial swelling then my throat started to swell/tighten. I was brought to the ED and an IV was started. They administered IV fluids, Benadryl, Prednisone, and Pepcid. The throat swelling started to interfere with my speaking and vocals. They monitored me for 7 hours then I was discharged home. All symptoms returned within a few hours and persisted for a week following. My PCP took over care and prescribed me the following in replace of the medications the ER prescribed: Albuterol HFA, Dexamethasome, Pepcid, Benadryl, Z-Pak, Vitamin D 100,000iu, and Fish Oil. I missed a week of week then was released to work again on 1/25/21.
31 2021-01-27 itchy skin, hives, rash 31 y.o. female with reported PMH of asthma who presents for SARS-CoV-2 vaccination Pfizer Dose #1. T... Read more
31 y.o. female with reported PMH of asthma who presents for SARS-CoV-2 vaccination Pfizer Dose #1. Ten minutes after receiving the vaccination, the patient began to experience itching and hives. The patient was brought back to the monitoring area and vital signs were checked and stable. The patient reports eating lunch before the vaccine appointment. The patient was given bottled water. Patient's hives and itching worsened, spreading to her chest, mouth, and arms. She was given dexamethasone 8mg IV, benadryl 50mg IV and famotidine 40mg PO. Symptoms persisted and she was transported to the ED.
31 2021-01-27 skin warm 5 weeks pregnant swollen lymph node, golf-ball sized on collar bone, same side as injection. Warm to... Read more
5 weeks pregnant swollen lymph node, golf-ball sized on collar bone, same side as injection. Warm to the touch and moveable, agitated by pressure and palpation.
31 2021-01-27 vaccination site redness, vaccination site mass, vaccination site swelling, vaccination site pain Localized redness and swelling (hard knot like) approximately the size of a half dollar; Localized r... Read more
Localized redness and swelling (hard knot like) approximately the size of a half dollar; Localized redness and swelling (hard knot like) approximately the size of a half dollar; Localized redness and swelling (hard knot like) approximately the size of a half dollar; pain the arm and shoulder; pain the arm and shoulder; This is a spontaneous report received from a contactable nurse (who is also the patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the right arm, on 11Jan2021 07:15, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 prior to vaccination. The patient has no known drug allergies and is not pregnant. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), omeprazole (PRILOSEC) and biotin. The patient did not receive other vaccine in four weeks. The patient experienced localized redness and swelling (hard knot like) approximately the size of a half dollar with continued pain the arm and shoulder on 12Jan2021. The patient was not tested for COVID-19 post vaccination. Treatment was reported as unknown. The outcome of the events was not recovered.
31 2021-01-27 pain of skin Some fatigue and arm pain the day after the vaccine. Starting 1/17/21 she had intermittent burning i... Read more
Some fatigue and arm pain the day after the vaccine. Starting 1/17/21 she had intermittent burning in her scalp. The following day she also started having a weird taste in her mouth. These symptoms continued and a few days after she also started having intermittent numbness and tingling in her face. The face parasthesias stopped on 1/23 or 1/24. The weird taste in her mouth is still intermittent but less frequent. The scalp irritation has mostly resolved.
31 2021-01-28 itchy skin, redness, injection site mass 15 hours after 2nd dose vomiting, intense pain over 3 days, swelling, redness, itching, lump at site... Read more
15 hours after 2nd dose vomiting, intense pain over 3 days, swelling, redness, itching, lump at site, numbness and tingling, low body temp, profusely sweating
31 2021-01-28 injection site pain Fever, chill, difficulty sleeping, fatigue, flu like symptoms, injection site soreness, severe muscl... Read more
Fever, chill, difficulty sleeping, fatigue, flu like symptoms, injection site soreness, severe muscle soreness
31 2021-01-28 injection site warmth Patient received Pfizer COVID-19 vaccine (second in series) at 12:34pm by RN in left Deltoid, came t... Read more
Patient received Pfizer COVID-19 vaccine (second in series) at 12:34pm by RN in left Deltoid, came to sit in observation area. At about 12:50pm she began to feel flushed and dizzy. Vital signs taken, 136/78 bp, HR 106 regular, normal SpO2. Noted to be mildly diaphoretic with left arm injection site warm to touch, no visible skin changes. No report or evidence on evaluation of respiratory distress. Normal mental status and orientation throughout. Benadryl 25 mg oral tab administered. She also drank apple juice and ate part of a sandwich. After about 15 minutes, bp normalized to the patient's baseline systolic ~110 and slower heart rate, dizziness and flushing resolved.
31 2021-01-28 hives, rash, redness This is a spontaneous report from a contactable other health professional (patient). A 31-year-old f... Read more
This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 14:30, at left arm, at single dose for covid-19 immunization. Medical history included migraines from an unknown date, Allergies to medications, food, or other products: penicillin, sulfa. Concomitant medication included propranolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) via an unspecified route of administration on 23Dec2020 15:00 at left arm, at single dose for covid-19 immunization. The patient experienced Severe rash, red skin and hives across my abdomen and legs. Hot to the touch, all on 16Jan2021 16:00. Treatment was reported unknown. The outcome of the event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
31 2021-01-28 injection site irritation irritation at injection site turned into all over body itchiness
31 2021-01-29 itchy rash, rash Itchy rash on face appeared 2 days after vaccine administration. Has not subsided yet.
31 2021-01-31 vaccination site pain Chills; Headache; Nausea; Myalgia; Arthralgia; fatigue; pain at site of injection; Start Date/Time: ... Read more
Chills; Headache; Nausea; Myalgia; Arthralgia; fatigue; pain at site of injection; Start Date/Time: (2nd dose) 15Jan2021 09:00 AM Start Date/Time: (1st dose) 29Dec2020 09:00 AM"; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at her right arm, via an unspecified route of administration on 15Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). Vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose). The patient experienced chills, headache, nausea, myalgia, arthralgia, fatigue, pain at site of injection; all on 15Jan2021 08:00. The patient did not receive any treatment for the events. The outcome of the events was recovering. Information on the batch/lot number has been requested.
31 2021-01-31 hives Full body hives, swollen bottom lip. Treated with benadryl, pepcid and prednisone.
31 2021-01-31 injection site pruritus Site: Itching at Injection Site-Medium; symptoms lasted 1 day
31 2021-01-31 itchy skin Tingling; felt itchy; swelling of the lips; This is a spontaneous report from a contactable healthca... Read more
Tingling; felt itchy; swelling of the lips; This is a spontaneous report from a contactable healthcare professional. A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 09Jan2021 09:30 at single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination), penicllin allergy, and shrimp allergy. Concomitant medications included cetirizine, fexofenadine and triamcinolone. On 09Jan2021 11:00. the patient experienced tingling, felt itchy and experienced swelling of the lips. Therapeutic measures were taken as a result of the events that include Benadryl and famotidine. Clinical outcome of the events was recovered on an unspecified date.
31 2021-02-01 skin spots Immune Thrombocytopenia Purpura; the only feature that was new to her was the vaccination provided 2... Read more
Immune Thrombocytopenia Purpura; the only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series; This is a spontaneous report from a contactable physician. A 31-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. Medical history included eczema, no known allergies. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on 23Dec2020 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seen in the ED for petechiae and ecchymoses on 15Jan2021. She had not taken any recent medication or had any illness previous to this event. The only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series. Lab assessment showed platelet count decreased to 22,000 cells per cubic microliter (normal over 140,000). She had no other findings to describe cause of her decreased platelet count by lab or clinical exam. Provided a diagnosis of immune thrombocytopenia purpura, in the ED setting, she started pulse dexamethasone 40 mg/day for four consecutive days with a follow blood count showing resolution on day 4 of her treatment with a platelet count of 230,000 cells per cubic microliter. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Steroids as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of event immune thrombocytopenia purpura was recovered in Jan2021. Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of immune thrombocytopenia purpura due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including platelet count at baseline and during therapy with subject drug, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-02-01 injection site nodule, hives, hardening My arm was pretty sore the first day and a few hours after the vaccine I got a headache. The headach... Read more
My arm was pretty sore the first day and a few hours after the vaccine I got a headache. The headache lasted 48 hours but was worse on the second day. The pain in my arm turned into a big red welt and a hard lump. I took ibuprofen for two days to help with the swelling and headache. The lump at the injection sight was probably 2 inches in diameter and raised a bit.
31 2021-02-01 rash, skin peeling, dry skin Pt noticed the rash over her trunk and extremities 1-2 days after the COVID vaccine. She has been se... Read more
Pt noticed the rash over her trunk and extremities 1-2 days after the COVID vaccine. She has been seen at the clinic on 1/5 and 1/6/2020. Denied itching, so no treatment was render. Pt applied skin moisturizure to her dry flaky skin after shower and feeling better the next day.
31 2021-02-01 rash maculo-papular, rash with redness, sensitive skin, itchy skin Received #2 dose of Pfizer Covid19 Vaccine on 1/08/21 at 10 AM. Approximately 12 hours later she wok... Read more
Received #2 dose of Pfizer Covid19 Vaccine on 1/08/21 at 10 AM. Approximately 12 hours later she woke up with right eye pruritus with sensitivity, maculopapular erythematous rash and itching over left cheek to temple. She was rubbing at her eyes and did develop local swelling around the right eye. She treated herself with benadryl and advil. Her swelling and eye sensitivity decreased later that day but she developed a fixed itchy maculopapular rash on btl forearms (pictures in chart). She works in the ED as a technician and was seen during her shift 36 hours post shot. Diagnosed with a possible delayed reaction to the vaccine and discharged with prednisone, allegra, hydroxyzine. Symptoms have resolved except for residual hyperpigmentation over areas on forearms where the rash was and still feels itchy, though this increased after stopping antihistamines for her visit. She reports no episodes of lightheadedness/syncope, increased nasal congestion, difficulty breathing post vaccine. She has no history of anaphylaxis or allergic reaction to prior vaccines.
31 2021-02-01 injection site pain numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and "no ... Read more
numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and "no control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up;it's numb; can barely move her right arm; paralyzed at the shoulder from the elbow up; flu like symptoms; Threw up a couple times; mild pain at the injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 31-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3247, Expiry date 31May2021, via an unspecified route of administration in right arm on 16Jan2021 at 07:30 at single dose for COVID-19 immunization as frontline worker. The patient had no relevant medical history. There were no concomitant medications. The patient received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine in Hospital. The patient reported that she was fine all day Saturday (16Jan2021), she just had some very mild pain at the injection site started a couple hours after getting injection. She developed flu like symptoms on the following day (17Jan2021) at 18:00PM and threw up a couple times. On 18Jan2021 at noon she noticed that she could barely move her arm: anything above her elbow on her right arm was not moving; it was paralyzed at the shoulder from the elbow up. If someone were to pick it up and let go, she couldn't control it at all. She also stated that she had no pain at all in that arm; she couldn't feel anything at all; it was numb. When she woke up on 19Jan2021 the numbness had moved up her neck, instead of being localized to her arm. She stated that when she touched her neck, it hurt a little, but it was not super significant. She stated that it was debilitating at that point as she was maintaining numbness and "no control of her arm". The nurse reported that this event had not required yet a visit to physician, but she has a feeling it will. She will probably have to go somewhere due to her paralyzed arm, but she had not yet. At the time of the report the event "No control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" had not resolved yet; the event "mild pain at the injection site" resolved on 17Jan2021, the events "Flu like symptoms" and "Threw up a couple times" were recovering and outcome of the events "Numbness has moved up her neck" and "She touches her neck, it hurts a little" was unknown. The reporter assessed the events "Pain injection site" and "Flu like symptoms" as non-serious and assessed the event "Can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" as disabling. She assessed all the reported events as related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (method of assessment: Global Introspection).; Sender's Comments: Based on the temporal relationship, the association between the events numbness of upper extremity and arm paralysis with BNT162b2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
31 2021-02-02 rash Muscle aches, fatigue. Rash on back - Taking Benadryl.
31 2021-02-02 shingles, rash Received COVID vaccine on 12/18/2020. On 1/2/2021 started to note inflammation of superior auricular... Read more
Received COVID vaccine on 12/18/2020. On 1/2/2021 started to note inflammation of superior auricular and superior cervical nodes. Rash on left side of head appear around 1/3/2021. On 1/7/2021 diagnosed with shingles.
31 2021-02-02 injection site pain injection site soreness, muscle pain, joint pain, fever 100.1, HA
31 2021-02-02 itchy skin patient had itching to second vaccine just like the reaction from previous vaccine and other medicin... Read more
patient had itching to second vaccine just like the reaction from previous vaccine and other medicines.
31 2021-02-03 hives, itchy skin Hives Lips swelling Eyes swelling Itchy skin
31 2021-02-03 itchy skin, hives body itching with some welts. all over. itching felt to be from the inside out.
31 2021-02-04 injection site pain Moderate pain at injection site, mild to moderate fatigue, mild joint pain, fever and chills
31 2021-02-04 vaccination site pain Supraclavicular and axillary lymphadema; tenderness only in side where shot was given; This is a spo... Read more
Supraclavicular and axillary lymphadema; tenderness only in side where shot was given; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 21Jan2021 10:15 for COVID-19 immunization. Age at vaccination: 31-year-old. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included asthma. The patient had no known allergies. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications within 2 weeks of vaccination. On 23Jan2021 07:00, the patient experienced supraclavicular and axillary lymphedema; and tenderness only in side where shot was given. No treatment was given for the events. The events were considered non-serious by the reporter. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events at the time of reporting. Information on the lot/batch number has been requested
31 2021-02-05 injection site pain Extreme fatigue, whole body muscle aches, hot and cold flashes, migraine, fever, extreme pain at inj... Read more
Extreme fatigue, whole body muscle aches, hot and cold flashes, migraine, fever, extreme pain at injection site, dizziness and light headed
31 2021-02-06 skin burning sensation Nausea, Light headed, burning and cold sensation in sternum.
31 2021-02-06 shingles Shingles
31 2021-02-06 itchy skin, redness Swollen red itchy painful toes on left foot less than 1 week after receiving dose. Intense pruritus... Read more
Swollen red itchy painful toes on left foot less than 1 week after receiving dose. Intense pruritus. Heard of ?Covid toes? so thought I should report here just Incase. Taking Benadryl to help with itching.
31 2021-02-07 skin spots Bloody mucus when blowing nose, petechia on legs 1/29/21.
31 2021-02-08 hives Approximately 15 minutes after patient received Pfizer vaccine #1 she began to experience shortness ... Read more
Approximately 15 minutes after patient received Pfizer vaccine #1 she began to experience shortness of breath, tachypnea, tachycardia, diaphoresis, and hives to upper extremities.
31 2021-02-08 pain of skin On left side of head, on same side as injection site, experiencing head that is painful/sore to the ... Read more
On left side of head, on same side as injection site, experiencing head that is painful/sore to the touch. The tenderness is in specific areas but only on the left side of head. Symptoms began about 6 to 8 hours after injection and persist currently over 24 hours later.
31 2021-02-08 injection site swelling, injection site pruritus, injection site redness Pregnant currently 8 weeks, baby doing fine at this moment. About 10 hours or so after my 2nd vacc... Read more
Pregnant currently 8 weeks, baby doing fine at this moment. About 10 hours or so after my 2nd vaccine, I started getting chills, low grade fever of 99.5F and it gradually got worse in the middle of the night, fever had spiked to 101.6F. I have history of pregnancy loss. I took some Tylenol for the fever and by the next morning my fever was better and my fever resolved. I got the swelling and erythema at the injection site, was bot four inches long and 3 inches wide and it was also itchy. The fever and chills resolved by the evening of hte next day. The swelling and erythema went down in a few days.
31 2021-02-08 injection site bruising Received around 11am, some dizziness and tunnel vision about 10 minutes after while sitting, resolve... Read more
Received around 11am, some dizziness and tunnel vision about 10 minutes after while sitting, resolved within minutes. That evening: fatigue, mild arm sore Overnight: shaking, chills, fever, more severe arm soreness Following day: fatigue, fever, chills Beginning that evening: fever/chills resolved, started having palpitations and dizziness with some shortness of breath. Had these for about 3 more days primarily at rest. Self resolved Vaccine #2 3 weeks later: medicated with Tylenol and Motrin q4 hours, some breakthrough chills and joint pain overnight, mild arm soreness. Self resolved the following day. Have continued bruising at injection site 3 weeks later Continue to have some intermittent palpitations and dyspnea. Not present prior to vaccine 1.
31 2021-02-09 vaccination site pain "pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/in... Read more
"pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/including the painful jolts whenever touched; Random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm; soreness to touch or movement of the entire upper arm inclusive of the shoulder; soreness to touch or movement of the entire upper arm inclusive of the shoulder; The soreness aside from the injection site did not abate; This is a spontaneous report received from a contactable consumer (the patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the upper left arm on 21Jan2021 14:10 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient's medical history included allergies to corn (zein). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen on 16Jan2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the vaccine around 14:10 (scheduled for 14:00 but there was a line). Upon standing (21Jan2021 14:15), there was a "pins-and-needles" sensation down to the elbow, and by the time seated for the 15 minute wait, the sensation was present in the whole arm. The sensation was identical to a limb that was "asleep", including the painful jolts whenever touched all the way to the tips of the fingers. This lasted until mid-morning 23Jan2021 (about 44 hours). Random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm (21Jan2021 14:15). These have shrunk but some are still present at the time of reporting. There was additional soreness to touch or movement of the entire upper arm inclusive of the shoulder (21Jan2021 14:15). The soreness aside from the injection site (21Jan2021 14:15) did not abate until late evening on 24Jan2021. The only noted adverse effects were related to physical sensation in the left arm. The patient did not receive any treatment for the events. The clinical outcome of "pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/including the painful jolts whenever touched was recovered on 23Jan2021. The clinical outcome of random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm; soreness to touch or movement of the entire upper arm inclusive of the shoulder; and soreness aside from the injection site, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
31 2021-02-09 hives, injection site pruritus, vaccination site pain, vaccination site mass, cellulitis, injection site redness Client reports that she had soreness and tenderness for 1-2 days in her left Deltoid where the vacci... Read more
Client reports that she had soreness and tenderness for 1-2 days in her left Deltoid where the vaccine was administered and then felt a lump in the same area. Then 10-11 days later she reported that her left Deltoid become red and itchy, and she developed a welt. She went to Urgent Care and the Physician diagnosed her with Cellulitis. She said they measured the welt as 4 1/2" x 6 1/2 " and treated her with topical Benadryl and oral antibiotics. She reported that the antibiotics were helping and the redness and swelling were decreasing.
31 2021-02-09 vaccination site pain Injection site pain; headache; muscle pain; Joint pain; chills; fever (100.9-103.6); feeling very un... Read more
Injection site pain; headache; muscle pain; Joint pain; chills; fever (100.9-103.6); feeling very unwell.; first dose was given on 04Jan2021 and the second was on 21Jan2021; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: GL3302, expiration date was not reported), via an unspecified route of administration on 21Jan2021 09:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included vilazodone hydrochloride (VIIBRYD), quetiapine, and mirtazapine (MIRTAZEPINE TEVA). She was not pregnant. She had no known allergies. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE (lot number: EJ1685) on 04Jan2021 in the left arm when the patient was 31-years old for COVID-19 immunization. The patient had no any other vaccine in four weeks prior covid vaccine. The patient had no covid prior vaccination. She was not tested for covid post vaccination. The patient experienced injection site pain, headache, muscle pain, joint pain, chills, fever (100.9- 103.6), and feeling very unwell, all on 21Jan2021 10:00 PM with outcome of recovered on an unknown date in 2021. It was reported that the first dose was given on 04Jan2021 and the second was on 21Jan2021. No treatment received for the events.
31 2021-02-09 rash Systemic: Rash (other than injection site)-Mild, Systemic: Other- SWELLING OF UPPER LIP-Mild; lasted... Read more
Systemic: Rash (other than injection site)-Mild, Systemic: Other- SWELLING OF UPPER LIP-Mild; lasted 1 day
31 2021-02-14 injection site pain About two hours after receiving the vaccination, I had severe dull pain in my entire leftarm which ... Read more
About two hours after receiving the vaccination, I had severe dull pain in my entire leftarm which received the vaccination. About 7 hours after the vaccination, I had extreme fatigue and slept for about 2 hours. I then got up to go to my neighbor's house (please note, it was about 4 degrees, -6 wind chill, outside at the time). When I got to the house, I stayed outside and smoked a cigarette for about 5 minutes. Upon going inside, I got extremely light headed, fatigued, my hearing went to "white noise" and a high pitched ringing, and my vision got blurry. I then left the house with assistance to head back home. While outside, despite the intense cold, I was dripping sweat in a matter of seconds. I continued sweating and experiencing effects akin to what is felt prior to passing out, for about 7-10 minutes. I then laid down and went to sleep. Third day, still some soreness in the arm, but only at the injection site. No more adverse experiences since.
31 2021-02-14 itchy skin, bruising Full body itching that started two days after getting the vaccine. The itching has led to small brui... Read more
Full body itching that started two days after getting the vaccine. The itching has led to small bruises forming on my legs and arms and even on my chest. I have tried lotions, ointments, oatmeal baths, antihistamines, triamcinolone ointment and oral prednisone with no relief.!
31 2021-02-15 rash Morbidiform Rash present on abdomen, trunk and back. Symptoms lasted for 4 days. I also had fever of... Read more
Morbidiform Rash present on abdomen, trunk and back. Symptoms lasted for 4 days. I also had fever of 100.2F for 1 night which resolved with Tylenol.
31 2021-02-15 itchy skin, injection site pruritus, rash Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic:... Read more
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild
31 2021-02-15 itchy skin left palmar itching throat scratchy from 12:50-13:20 BP 146/93 HR 84 5 min post: BP 143/96, HR 84 10... Read more
left palmar itching throat scratchy from 12:50-13:20 BP 146/93 HR 84 5 min post: BP 143/96, HR 84 10 min post: BP 129/88, HR 76
31 2021-02-17 rash with redness, hives Red rash all over body; Hives on legs, butt, stomach, lower stomach, arms, hands, feet, face, neck a... Read more
Red rash all over body; Hives on legs, butt, stomach, lower stomach, arms, hands, feet, face, neck and back; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL4262), via an unspecified route of administration in the left arm on 27Jan2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Jan2021 at 15:00, the patient experienced red rash all over body and hives on legs, butt, stomach, lower stomach, arms, hands, feet, face, neck and back. The events required a visit to the emergency room and physician's office. The patient was treated with methyprednisolone (MANUFACTURER UNKNOWN), epinephrine (MANUFACTURER UNKNOWN), and diphenhydramine (MANUFACTURER UNKNOWN). The clinical outcomes red rash all over body and hives were not recovered.
31 2021-02-18 sensitive skin Next day started with arm soreness when woke up. A couple hours started having headache, chills, arm... Read more
Next day started with arm soreness when woke up. A couple hours started having headache, chills, arm soreness, numbness and tingling in hands for a couple minutes, skin sensitivity, stomach upset, temperature in the evening up to 102.6, full body aches, and fatigue.
31 2021-02-18 redness Patient reports feeling warm and redness on arms, provided Benadryl, patient felt okay after 15 minu... Read more
Patient reports feeling warm and redness on arms, provided Benadryl, patient felt okay after 15 minutes, stayed for observation for 30 minutes. Temperature was 98.2.
31 2021-02-21 injection site pain, injection site reaction, injection site swelling, injection site hives 1/26/2021 vaccination 1/27 I got up to breast feed daughter, I could tell I was achy, chills, sweat... Read more
1/26/2021 vaccination 1/27 I got up to breast feed daughter, I could tell I was achy, chills, sweating. Progressed as day went on. Lasted for approximately 3 days. Sore arm, raised welt on arm at injection site. Sore throat, my lymph nodes were swollen. * 1/8 COVID +
31 2021-02-21 rash, redness The night of the second dose of my Pfizer Covid vaccine, my face began to feel hot and tight. The ne... Read more
The night of the second dose of my Pfizer Covid vaccine, my face began to feel hot and tight. The next day, I began with the expected flu like symptoms of the vaccine, accompanied by a red, fine bumpy rash with some swelling on my face where it had felt hot and tight the evening prior. The flu like symptoms lasted about 24 hours. The facial rash persisted and I began oral antihistamines - diphenhydramine and famotidine. The rash continued for one full week, only improving after beginning to use topical hydrocortisone on my face at the suggestion of a friend who is a nurse practitioner. After improvement in the rash I stopped hydrocortisone and antihistamines. The rash reappeared about 5 days later, and continues to randomly reappear about once a week to every 10 days. Flares only last about 24-36 hours now and will go away without medication but it does clear faster with hydrocortisone and antihistamines. The rash only flares at night, and no triggers like heat, alcohol or certain foods seem to bring it out. I have been consistently taking famotidine and cetirizine daily since the last flare of the rash, and have not experienced a flare again yet.
31 2021-02-21 injection site pruritus, injection site redness, injection site swelling, injection site warmth, injection site rash rash and raised skin around injection site, itchy, red on 2/20 at 10pm; took some bennedryl allergy ... Read more
rash and raised skin around injection site, itchy, red on 2/20 at 10pm; took some bennedryl allergy orally, lessend symptoms, but did not eliminate. 2/21 - more red, hot around area, itchy, but not as bad as the day before. 2/22 - still slightly itchy, a little less red, still pretty raised and warm.
31 2021-02-22 rash, itchy skin, rash with redness 4 days after vaccine developed Small red bump dotty rash starting on abdomen and middle back and spr... Read more
4 days after vaccine developed Small red bump dotty rash starting on abdomen and middle back and spread to more areas on torso/chest/upper and lower back. Itchy. Not relieved by Benadryl. Attempting home treatments such as hydrocortisone cream and colloidal oatmeal bath for itching. Will go to MD if not improved after one week or continuing to worsen
31 2021-02-23 rash with redness, itchy skin, rash, rash papular, skin warm, hives Mon 2/22 had a few spots throughout my body at different times in the day starting in the morning, l... Read more
Mon 2/22 had a few spots throughout my body at different times in the day starting in the morning, looked like mosquito bites, by evening, it had shown up on my legs, arms, back, stomach, my ears were hot and itchy, took 1 Benadryl 10:00 PM, went to bed Tue 2/23 6:30 AM widespread rash on both arms and both legs and isolated spots on my trunk, large areas raised red bumpy splotchy 9:40 AM sick visit appointment to see NP at my primary care office, prescribed zyrtec 10 mg in the morning, pepcid 20 mg at lunch, benadryl at night Took pepcid with lunch 3:00 PM put on a lot of lotion over my entire body, hives less pronounced, not as raised, still itchy but not as much Evening some small spots on face near hairline, took 1 benadryl Wed 2/24 morning upon waking hives not as severe, but still present and itchy, eyes slightly puffy, palms itchy but can?t see any hives, overall better than the previous 2 days Took zyrtec with breakfast, pepcid with lunch (now it is currently 4 PM haven't taken benadryl yet for the evening)
31 2021-02-24 rash macular, rash Fever, chills, headache, body ache appx 12-36 hours after receiving 2nd dose Red splotches on stoma... Read more
Fever, chills, headache, body ache appx 12-36 hours after receiving 2nd dose Red splotches on stomach and creeping to back, arms, and legs several days after receiving 2nd dose Rash is persistent after 20+ days
31 2021-02-24 redness, itchy skin Patient developed itching and redness on forehead, no SOB, no hives.
31 2021-02-24 skin burning sensation Upper body burning only at night without fever. Onset the night after vaccination date. Lasted for t... Read more
Upper body burning only at night without fever. Onset the night after vaccination date. Lasted for two nights. Extreme fatigue. started a day after vaccination and lasted for 3 days.
31 2021-02-26 injection site swelling swelling at injection site
31 2021-02-27 injection site pain, injection site rash, injection site pruritus, injection site warmth Headache, arm soreness, rash on site with heat and itchiness, bump on site, fever of 100 26 hours af... Read more
Headache, arm soreness, rash on site with heat and itchiness, bump on site, fever of 100 26 hours after vaccine, aches, chills, sollen and painful lymph node in arm pit area on 2nd day after
31 2021-02-27 sensitive skin Symptoms started about 11 hours after administration of vaccine. Resting heart rate averaging 120 bp... Read more
Symptoms started about 11 hours after administration of vaccine. Resting heart rate averaging 120 bpm. Up to 160 bpm on exertion, involuntary movement of my whole body like restless leg syndrome, chills, fever of 101.8, vomiting, profuse sweating, hypersensitive skin causing burning pain when anything touched my skin, headache, dizziness. Benadryl, acetaminophen, and ibuprofen given around the clock at appropriate intervals with not much relief for the first 48 hours.
31 2021-02-28 rash with redness, itchy skin, itchy rash Bee sting on sole of foot morning of getting her second Pfizer dose. She then had a "spider bite" on... Read more
Bee sting on sole of foot morning of getting her second Pfizer dose. She then had a "spider bite" on her abdomen the next day. About 3 days later she developed an itching, lacy, red rash on dorsum of foot and sought care at an urgent care. She was given cephalexin for the spider bite and prednisone 40 for the bee sting. She had never had a reaction to bee stings before and no history of any anaphylaxis. She then came to see me, and I noted the rash with a red rash also over her left second toe with no signs of arterial occlusion or neurologic symptoms. She had no symptoms or known Covid exposure and the community positivity rate was 1%. We decided to try a high potency topical corticosteroid for the itching on her foot and use the prednisone if symptoms worsened or go to the ER if severe. The next morning, (7 days post vaccination) she reported lightheadedness, increased pruritus of her foot and went to an urgent care where she started systemic prednisone and had a negative Covid nasopharyngeal swab. She then recovered without complications.
31 2021-03-01 hives, itchy skin Hives all over. I?ll take Benadryl and they go away but then they come right back. Extreme itchiness... Read more
Hives all over. I?ll take Benadryl and they go away but then they come right back. Extreme itchiness and occasional sore throat. My PCP is sending a steroid pack to calm them down hopefully
31 2021-03-01 injection site pruritus, injection site redness Itching/Redness at injection site that spread no more than 6 inches from site (I took 25mg Benadryl ... Read more
Itching/Redness at injection site that spread no more than 6 inches from site (I took 25mg Benadryl OTC and reaction subsided). 02/24/2021 approximately 12:30pm low grade fever 99.5F with aches/chills/head ache/decreased appetite/dizziness/weakness (I took 1000mg Tylenol, however symptoms persisted through 02/25/2021 before subsiding) Called out sick for work on 02/25/2021. 02/26/2021 Vertigo that subsided 02/27/2021.
31 2021-03-02 shingles Developed shingles infection 10 days after second covid vaccine
31 2021-03-02 injection site pain Got vaccine in left deltoid. In the next week started having left arm pain along ulnar distribution ... Read more
Got vaccine in left deltoid. In the next week started having left arm pain along ulnar distribution and left sided chest pain consistent with costochondritis.
31 2021-03-02 injection site pain chills, goosebumps, for about 2-3 hours and slight fever for about 12 hours. severe pain around inje... Read more
chills, goosebumps, for about 2-3 hours and slight fever for about 12 hours. severe pain around injection site, more severe than a regular vaccine injected reaction site- lasted about 48 hours. fatigue and body pain about 12 hours
31 2021-03-03 hives Chills, urticaria, dizziness, tachycardia Pt complained of palpitations immediately after vaccinatio... Read more
Chills, urticaria, dizziness, tachycardia Pt complained of palpitations immediately after vaccination. Dizziness, hives, chills and tremor associated. Hx of Mast-Cell d/o and anaphylaxis to NSAIDs. No reaction to first dose. Initial BP 136/93, HR 147, O2 100% RA. Pt appeared pale, tremor Patient sent to ED.
31 2021-03-04 rash, hives, injection site numbness, injection site pain Six days after the second COVID vaccine, I experienced significant pain in my left arm (injection si... Read more
Six days after the second COVID vaccine, I experienced significant pain in my left arm (injection site), tingling, numbness, etc. Rash and hives covering large parts of my chest, abdomen, back, buttocks, legs, and feet was prominent. Can attach pictures.
31 2021-03-05 hives, itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA: Patient reports itching/hives hives starting on trunk and abdo... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient reports itching/hives hives starting on trunk and abdomen that spread to limbs the day after vaccination. Denied respiratory symptoms, swelling, vocal changes, vomiting, diarrhea, vocal changes, and palpitations. Symptoms resolved with home care, including diphenhydramine, within 36 hours of onset.
31 2021-03-06 injection site pain 10 weeks pregnant, due October 1. Chills, fatigue, stiff joints, injection site pain.
31 2021-03-08 injection site pain Injection site pain and soreness starting immediately (of course). Mild nausea starting about 3 hour... Read more
Injection site pain and soreness starting immediately (of course). Mild nausea starting about 3 hours after injection. Severe chills 17-20 hours after injection. Nausea and vomiting about 19-20 hours after injection. General malaise feeling, tiredness, and moderate headache lasting up to ~26 hours after injection (but that could've just been because I didn't sleep and was dehydrated).
31 2021-03-08 itchy skin Pt initially reported facial pruritus and the mild sensation of her throat closing. Discussed givin... Read more
Pt initially reported facial pruritus and the mild sensation of her throat closing. Discussed giving epi but pt requested delaying as she reports her throat feeling better. Benadryl provided to help with pruritus since throat tightening improved. Tightening of her throat later worsed and was associated with dysphagia. Epi was administered and EMS contacted. Pt's symptoms completely resolved before transport to the hospital.
31 2021-03-08 itchy skin SWELLING ON EYES ,HOT FLASHES AND INCHING. WENT TO EMERGENCY ROOM SOLOMEDROL 125MGS IV,BENADRYL 50 M... Read more
SWELLING ON EYES ,HOT FLASHES AND INCHING. WENT TO EMERGENCY ROOM SOLOMEDROL 125MGS IV,BENADRYL 50 MGS IV AND PEPCID 20 IV. NEXT DAY WITH LESS SINTOMES.
31 2021-03-10 rash, itchy rash Rash itching on left antecubital area
31 2021-03-11 itchy rash, shingles, rash papular A week after receiving my first injection I started to notice a tender and itchy raised rash on my b... Read more
A week after receiving my first injection I started to notice a tender and itchy raised rash on my back (left side). I saw the dermatologist who diagnosed me with shingles and placed me on a course of Valtrex.
31 2021-03-11 hives, itchy skin Itching/hives on chest, arms, and neck 3 hours after injection. Took one Benadryl at 3.5 hours post ... Read more
Itching/hives on chest, arms, and neck 3 hours after injection. Took one Benadryl at 3.5 hours post injection (present time).
31 2021-03-11 redness, itchy skin Patient developed redness and itching in left arm, upper left chest and neck. Patient declined diphe... Read more
Patient developed redness and itching in left arm, upper left chest and neck. Patient declined diphenhydramine due to increased risk of drowsiness, and declined observation. Patient declined care of EMS as well. Patient states she will go home and take benadryl at home.
31 2021-03-11 injection site pain chills, fatigue, body aches, nausea, dizziness, lethargy, sore arm at the injection site - NSAID tak... Read more
chills, fatigue, body aches, nausea, dizziness, lethargy, sore arm at the injection site - NSAID taken with mild improvement
31 2021-03-12 hives I have hives all over my body. It started Wednesday evening I think on my lower back and has progres... Read more
I have hives all over my body. It started Wednesday evening I think on my lower back and has progressed to spots all along my right arm, left, shoulder/chest, stomach, neck, and legs in that order. At first I thought it may be ivy even though I haven't been hiking anywhere because I've never had hives before. I actually don't think I've ever had poison ivy either. The spots appear randomly and have been showing up in new areas of my body consistently since Wednesday. Today is Saturday.
31 2021-03-14 rash 12/20 vaccination 45 Minutes later, I looked at my hand and it had a rash; little red marks like hiv... Read more
12/20 vaccination 45 Minutes later, I looked at my hand and it had a rash; little red marks like hives; R arm. My left arm was numb it felt better with time; sore. Took some Tylenol. Rash didn't last long 30-60 minutes.
31 2021-03-14 injection site warmth Dizziness, mild shortness of breath, arm hot at injection site
31 2021-03-15 itchy skin, hives, rash with redness, dry skin Hives/red bumps/ itching/dry spots on my skin/ marks
31 2021-03-16 itchy skin About 20 minutes after injection Itching in throat and cheeks. Bumps in back of throat present. Aler... Read more
About 20 minutes after injection Itching in throat and cheeks. Bumps in back of throat present. Alert, speaking in full sentences, sensation did not worsen. Gave 25mg Benadryl and symptoms improved.
31 2021-03-16 injection site warmth At the moment of the infection I felt nothing. When I stood up and unfolded mi arm I felt a shooting... Read more
At the moment of the infection I felt nothing. When I stood up and unfolded mi arm I felt a shooting pain along mi arm all the way to my fingers( don't remember exactly which fingers) and I started to feel my arm get hot from the site of injection towards my fingers. It lasted for about 1 to 2 minutes. And I had a residual shooting pain for about 5 minutes, coming and going. Then at 9 pm I had my fingers completely swollen, I couldn't take my rings off. I still have my hand swollen. My arm has the normal pain that the injections is supposed to give, I can't raise my arm quite well without having pain on it.
31 2021-03-16 hives Diffuse urticurial rash on abdomen, chest, back, arms, thighs.
31 2021-03-17 injection site reaction, hives Pfizer-BioNTech COVID-19 Vaccine EUA After about 12 hours, I noticed welts on the same arm where I ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA After about 12 hours, I noticed welts on the same arm where I received the injection. There were about 4, some very small and some medium sized. I monitored them for the next 3 hrs and they did not get any bigger. They weren?t red or any sort of color really. The next morning they were completely gone.
31 2021-03-17 rash with redness, rash papular Raised red bump rash on left arm (injection arm) on inside of elbow
31 2021-03-17 injection site swelling, rash, shingles Soon after the first dose patient developed lymphadenopathy beneath the L armpit (location of vaccin... Read more
Soon after the first dose patient developed lymphadenopathy beneath the L armpit (location of vaccine administered). This resolved. After the second dose developed lymphadenopathy beneath the R armpit (location of vaccine administered on R arm). X 4 days ago developed new onset Shingles in V1 distribution L face. Patient has been started on anti viral treatment. COVID Vaccine Dose 1: 2/9/2021 L arm COVID Vaccine Dose 2: 3/2/2021 R arm; small lump under armpit, small, resolved Shingles rash: 3/15/2021
31 2021-03-17 itchy skin Within 24 hours of first dose, swelling of lips have occurred and are continuing to swell. Tingling ... Read more
Within 24 hours of first dose, swelling of lips have occurred and are continuing to swell. Tingling and burning sensation present accompanied with itching around lips and face. Benadryl, Claritin and Pepcid are currently being taken to reduce swelling.
31 2021-03-18 itchy skin Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
31 2021-03-19 injection site inflammation, injection site warmth, injection site rash 6 days after the COVID 19 vaccine I started having soreness in my left armpit lymph nodes. 8 days af... Read more
6 days after the COVID 19 vaccine I started having soreness in my left armpit lymph nodes. 8 days after, my right arm became sore, hot, achy, inflamed and had a rash around the injection sight. This lasted about 2 days.
31 2021-03-19 redness Facial erythema/edema, mild respiratory distress. Vitals wnl.
31 2021-03-19 skin warm, injection site pain, hives, rash The day I received the vaccine, I had the typical symptoms of sore arm and exhaustion. The next day,... Read more
The day I received the vaccine, I had the typical symptoms of sore arm and exhaustion. The next day, I slept most of the day and had an awful headache that would not go away with ibuprofen/tylenol. Day 3 after receiving the vaccine, about an inch down from my vaccine sight I had a warm, welt looking rash about the size of a tennis ball. It is just now starting to fade and it has been 6 days since I received the vaccine.
31 2021-03-19 injection site redness, injection site swelling, injection site pruritus, injection site pain, injection site hardening pain, swelling, redness at site after 2 days. this went away. came back 7 days post-injection with e... Read more
pain, swelling, redness at site after 2 days. this went away. came back 7 days post-injection with edema, induration, pruritis. no pain. size about 2.5in in diameter.
31 2021-03-20 redness, injection site rash 2 red circles/rash appeared on upper left arm
31 2021-03-20 injection site pain, injection site pruritus, injection site swelling Joint and body aches, chills, extreme fatigue and weakness lasting until 48 hours after onset. Exper... Read more
Joint and body aches, chills, extreme fatigue and weakness lasting until 48 hours after onset. Experienced muscle pain, swelling, and itchiness at injection site.
31 2021-03-21 injection site numbness At 12;45 pt received vaccine, she says her left arm felt numb but didn't verbalize reaction until 1p... Read more
At 12;45 pt received vaccine, she says her left arm felt numb but didn't verbalize reaction until 1pm. Vital signs B/P 125/80, resp 16, pulse 80, and reporting feeling dizzy. Pt says her left arm feels numb from the elbow to shoulder. Pt denied wanting to go to ER, refusing further treatment despite multiple education attempts. B/P 128/74 on last recheck, pt refusing continued treatment. Signed adverse reaction by patient.
31 2021-03-21 injection site pain Event: Pain at injection site, dizziness, nausea. Treatment: Rest, Outcome: symptoms dissipated
31 2021-03-21 skin warm Racing Heartbeat/Weakness -- half hour after injection; resolved on it's own Rash on ride side of to... Read more
Racing Heartbeat/Weakness -- half hour after injection; resolved on it's own Rash on ride side of torso -- rash was not noticed until several hours later (it was warm to the touch, was not raised not raised but more like sunburn and turned white upon pressing) and then resolved; rash reappeared on March 18 and resolved *photos available upon request
31 2021-03-22 rash with redness, injection site warmth, injection site rash A red and hot-to-the-touch rash developed on right elbow. Sore joints on right arm. Headache. Genera... Read more
A red and hot-to-the-touch rash developed on right elbow. Sore joints on right arm. Headache. General mental fogginess.
31 2021-03-22 injection site numbness, itchy skin Face: numbess, burning, throbbing pain. Difficulty swallowing. Face symptoms started on left side bu... Read more
Face: numbess, burning, throbbing pain. Difficulty swallowing. Face symptoms started on left side but appear on both sides. Left arm is numb. dizziness, weakness, fatigue. Full body itching.
31 2021-03-22 vaccination site pain, rash Rash broke out over body; Chills; Pins and needles sensation; shaking; Hand is cold; fever; fatigue;... Read more
Rash broke out over body; Chills; Pins and needles sensation; shaking; Hand is cold; fever; fatigue; headache; pinched nerve; Achy; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; This is a spontaneous report from a contactable other health professional (other HCP) (patient) reported for herself. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203) via an unspecified route of administration at left arm on 26Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunisation. Medical history included congenital sucrase-isomaltase deficiency (CSID). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264) via an unspecified route of administration at right arm on 03Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunization. No known allergies. No other vaccine in four weeks. Other medications in two weeks included topirmirate, levonorgestrel (MIRENA, intrauterine device (IUD)) and low-dose naltrexone (LDN). The patient was not pregnant. Facility type vaccine was at hospital. The patient experienced adverse events included: 12 hours: chills, fever, shaking; 24 hours: achy, fatigue, headache wouldn't go away 6 days: Rash broke out over body (have pictures), pain/tingling and numbness in left arm (injection site). Rash responded to diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC), left arm was still tingling and painful on day 7. Almost felt like pinched nerve. Hand was cold. Pins and needles sensation. The adverse event start date was reported as on 04Mar2021 at 06:30 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not resolved. Treatment received for adverse event included OTC treatment with antihistamines; epinephrine (EPIPEN). No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events rash and chills cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
31 2021-03-22 hives, itchy skin fever and chills the evening following the second shot. Sunday and Monday started experiencing itch... Read more
fever and chills the evening following the second shot. Sunday and Monday started experiencing itching on my legs. Monday during the night hives broke out on both of my legs itching uncontrobally.
31 2021-03-23 rash APPROXIMATELY 2 HOURS AFTER VACCINATION PATIENT REPORTED START OF RASH WHICH BECAME FULL BODY. SHE A... Read more
APPROXIMATELY 2 HOURS AFTER VACCINATION PATIENT REPORTED START OF RASH WHICH BECAME FULL BODY. SHE ALSO REPORTED A PERIOD OF HEART PALPITATIONS, HEADACHE, AND FEVER. SHE ALSO STATED SHE FELT LIKE SHE WAS IN A FOG YESTERDAY (DAY AFTER VACCINATION).
31 2021-03-23 itchy rash, rash papular, rash with redness Rash on the right arm - forearm and elbow, red, raised, itchy with little postules
31 2021-03-23 injection site pain pain at the injection site, headache, muscle soreness, fatigue, fever and chills. Chills began the f... Read more
pain at the injection site, headache, muscle soreness, fatigue, fever and chills. Chills began the following day in the afternoon and fever came down within ~6 hours. By midnight I had recovered from all adverse events.
31 2021-03-24 rash, itchy skin Within 20 mins of injection: Headache Tingling in face Pressure in top of head A lot of gas in ches... Read more
Within 20 mins of injection: Headache Tingling in face Pressure in top of head A lot of gas in chest Lightheadedness Swollen neck/lymph nodes Face itching Sinus pressure Shortness of breathe Cold sweats Rashes Still currently: Rashes Gas Headache Slight lightheadedness
31 2021-03-26 itchy skin ITCHING. REC'D BENADRYL. LATER STATED SHE GETS ITCHY WITH ALMOST EVERY MED SHE TAKES, LIKE PSYCHOGEN... Read more
ITCHING. REC'D BENADRYL. LATER STATED SHE GETS ITCHY WITH ALMOST EVERY MED SHE TAKES, LIKE PSYCHOGENIC URTICARIA
31 2021-03-27 injection site pain My left arm feels weak. Not really sure how to describe it. It is functioning normally. Every time I... Read more
My left arm feels weak. Not really sure how to describe it. It is functioning normally. Every time I am about to lift something, it feels like I won?t be able to, even though I can. I have normal range of motion. It is possible I slept on it wrong. I only had pain at the injection site for 2 days, and this is day 4. No rash, redness, or pain of any kind.
31 2021-03-28 hives Approx 5 minutes after receiving shot my heart started racing, I began to shake, hives spread across... Read more
Approx 5 minutes after receiving shot my heart started racing, I began to shake, hives spread across my chest, neck and back. I was given a shot of epinephrine via an Epi-pen by a medical provider at the vaccine site and was then transferred to ER.
31 2021-03-28 redness Tingling all over throat, face, arms legs, swollen throat, redness all over neck and chest
31 2021-04-02 rash Drug ineffective; covid test result=Positive; fever; chills; body ache; headache; fatigue; Rash/red ... Read more
Drug ineffective; covid test result=Positive; fever; chills; body ache; headache; fatigue; Rash/red splotches on stomach, worsening; red splotches on stomach, worsening; This is a spontaneous report from a contactable other health care professional reported for a 31-Year-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EK5730), via intramuscular on 28Jan2021 at 15:15 as single dose in left arm for covid-19 immunization. The patient's medical history included anemia, scoliosis, and anxiety. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMIN) and ethinylestradiol, norgestimate (MONO-LINYAH). Historical vaccine included BNT162B2 (administration date-07Jan2021, administration time-12:15 PM, administrator route-Intramuscular, vaccine location-Left arm, dose number-1 and Lot number-EL3248). On 28Jan2021, the patient experienced fever, chills, body ache, headache, fatigue, red splotches on stomach and worsening over time. On an unknown date, she experienced rash. The patient experienced events at Doctor or other healthcare professional office/clinic visit. Laboratory details included Nasal Swab (PCR) with results positive on 22Feb2021. It was unknown if patient was received treatment for the events. The outcome of the events was not recovered whereas the event drug ineffective was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-04-08 blister Received vaccine at Covid-19 pop-up clinic on 4/5/21 at 2:30pm. Was fine during the vaccine administ... Read more
Received vaccine at Covid-19 pop-up clinic on 4/5/21 at 2:30pm. Was fine during the vaccine administration. Waited 30 minutes after vaccination and left the clinic and felt fine. About 15-30 minutes later she was driving around running errands and was drinking water in the car and she noticed that it was becoming hard to swallow. Felt dizzy and disoriented and called her allergist. She carries epi pen because she gets allergy shots due to dog and cat allergies. Epi pen is for potential reaction to allergy shot. Allergist advised her to call EMS. She called EMS and they told her to administer the epi pen. She administered epi pen and began to feel symptoms improve. EMS arrived and she felt better and was not transported to the hospital. She drove herself home and was fine the rest of the day. She also had a topical reaction to the band-aid on her arm, with blisters and ripping off her skin. She generally has allergy issues with adhesives.
31 2021-04-11 injection site bruising, itchy skin Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Alle... Read more
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Severe
31 2021-04-12 hives Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient reported throat itching. Parame... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient reported throat itching. Paramedic administered oral diphenhydramine twice at vaccination site. Patient then reported chest pain, shortness of breath, urticaria, and increased throat scratching. Paramedics administered epinephrine twice and methylprednisolone and transported to emergency department (ED). On arrival to the ED patient still reported chest tightness, numbness, and was tachycardic (pulse 122 beats per minute), tachypneic (26 breaths per minute), and hypertensive (blood pressure 139/85). In the ED patient experienced more difficultly breathing and epinephrine continuous infusion was started. Laryngoscopy did not document evidence of airway compromise. Patient diagnosed with possible anaphylaxis and admitted (currently still hospitalized).
31 2021-04-12 vaccination site pain fainted; having an odd taste in my mouth; shortness of breath/breathing took 40 minutes to return to... Read more
fainted; having an odd taste in my mouth; shortness of breath/breathing took 40 minutes to return to normal; vasovagal syncope response; the expected sore injection site; headache; felt overheated; could quite literally only see stars; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Apr2021 10:45 (Lot Number: ER8732) as single dose for covid-19 immunisation. Medical history included hypoglycaemia (she ate before the injection) and fainting. Concomitant medication(s) included Birth control and prednisolone acetate ophthalmic sus. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. 5 minutes after the injection, the patient began having an odd taste in mouth, shortness of breath, and she fainted. She had a history of fainting, but it took longer for her to recover than usual (50 minutes instead of 15). When she regained consciousness a few minutes after, she had a headache, felt overheated, and could quite literally only see stars. Her breathing took 40 minutes to return to normal, and her body temperature took 2 hours to feel normal. She assumed this was mostly a vasovagal syncope response, but she wasn't anxious or in pain beforehand. After 6 hours, she still have the odd taste, a headache, and the expected sore injection site. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included Paramedic took vitals and monitored for an hour. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
31 2021-04-18 hives hives all over body; UTI; huge cold sore on nose; This is a spontaneous report from a contactable Ot... Read more
hives all over body; UTI; huge cold sore on nose; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), via an unspecified route of administration at Left Arm on 26Jan2021 17:30 (at age of 31 years old) at single dose for COVID-19 immunisation. Medical history included allergies: Sulfa. Concomitant medications included fluoxetine hydrochloride (PROZAC); vitamin d nos; clarithromycin (MACROBID). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ek9231) on 07Jan2021 05:30 PM at left arm at 31 years old at single dose for COVID-19 immunisation. No COVID prior vaccination. Nasal Swab on 09Mar2021 was Negative. On 26Jan2021 09:00 PM, within 5 hours of getting my second vaccination, patient broke out in hives all over body. Patient called doctor and was prescribed steroids to help with the hives as antihistamines were not helping. A few days later patient woke up with a huge cold sore on nose which patient never had before. The same day patient was experiencing symptoms of a UTI and was prescribed Macrobid which had taken several times before. Within an hour of taking it patient's body was covered in hives and throat started to close. Patient immediately went to urgent care where received a shot of Benadryl. Patient was confident this reaction would not have happened if patient had not had this vaccine. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment (Prednisone and a shot of Benadryl) received. The outcome of the events was recovered in 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hives, UTI, Cold sores cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-04-19 rash 31 year old female who presented to the ED on 4/17/21 complaining of generalized weakness. She repor... Read more
31 year old female who presented to the ED on 4/17/21 complaining of generalized weakness. She reports that since receiving the Pfizer Covid vaccine approximately one month ago she's been feeling unwell. She received Covid vaccine on 2/19 & 3/12. Over the next week she developed began having episodes of nausea vomiting and diarrhea. She was considering issues such as pregnancy and had at least 10 pregnancy test over the last 2 weeks her symptoms worsened and she began having weakness and general malaise. She reports the weakness originally started with the lower extremities and then she was unable to walk and required 2 people to help her stand. She denies any chest pain or shortness of breath, she does have some dizziness and lightheadedness. She does report that she had palpitations over the last week that were gradually worsening increasing in both frequency and duration. Also reports a rash that started on 4/17/21. She has notable lower extremity edema. Clinical course worsened requiring hemodialysis, intubation and a transferred. Hospital on 4/20/21. Assessment indicates patients primary issue is the cardiomyopathy, as there is no evidence of thrombocytopenia, questionable viral cardiomyopathy with subsequent multiorgan dysfunction syndrome . Pt was vaccinated at hospital.
31 2021-04-20 injection site redness, injection site swelling metallic taste in the mouth, arm soreness, redness around the injection site, swelling
31 2021-04-26 itchy skin Pt began with hot ears, itching on trunk within 15 min after receiving vaccine. States this happens... Read more
Pt began with hot ears, itching on trunk within 15 min after receiving vaccine. States this happens with a lot of medications Symptoms progressed resulting in transport to ED
31 2021-04-27 rash Immediate rash on hands, spread to arms and metallic taste in tongue and tingling.
31 2021-05-05 injection site swelling While getting the shot my arm was twitching like crazy. The next day on the arm where I got the shot... Read more
While getting the shot my arm was twitching like crazy. The next day on the arm where I got the shot a bump appeared. No pain. The next day the left side of my face was feeling funny. Very twitchy. The following day was the right side and face felt very stiff. And Today 5/6 I have a big bump on my right side of my neck and clavicle bone. Very swollen and sensitive.
32 2021-01-01 hardening Middle of the night woke up shivering, chills, fever, bones ached, could not even lift my arm it was... Read more
Middle of the night woke up shivering, chills, fever, bones ached, could not even lift my arm it was so sore and under armpit. Symptoms lasted all day. Next night woke up out of sleep symptoms even worse. Next day same symptoms but now a hard ball that hurts formed near clavicle on side of vaccinated arm. Arm, armpit, clavicle area on right side now all hurt.
32 2021-01-02 injection site swelling, injection site bruising, injection site pain Bruise, swelling, pain at injection site immediately following administration. Fatigue starting 12 ... Read more
Bruise, swelling, pain at injection site immediately following administration. Fatigue starting 12 hours after Muscle aches and joint pain 24 hours after
32 2021-01-02 shingles Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as f... Read more
Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as fatigue. Sx worsened on day 5, so I had a virtual visit with a medical provider who prescribed me Valtrex x7d to treat suspected Herpes Zoster, which I previously had in my early 20s.
32 2021-01-02 injection site pain Pain at injection site Chills Low grade fever
32 2021-01-02 injection site pain Pfizer-BioNTech COVID-19 vaccine EUA Moderate injection site soreness and stiffness, mild body aches... Read more
Pfizer-BioNTech COVID-19 vaccine EUA Moderate injection site soreness and stiffness, mild body aches, chills, headache and runny nose Symptoms started within 12 hours of receiving.
32 2021-01-02 injection site pain Pfizer-BioNTech COVID19 Vaccine EUA The muscles in my arm where the vaccine was objected started hur... Read more
Pfizer-BioNTech COVID19 Vaccine EUA The muscles in my arm where the vaccine was objected started hurting about 5 hours after the vaccine. Two hours later the pain had gotten so intense I could not move my arm more than in inch from my body and had to get help performing simple tasks. The next morning, the pain is less intense and I can move my arm, but there is no pain in my elbow and wrist joints on the same arm.
32 2021-01-02 rash, itchy rash, skin irritation, rash with redness Rash and small red bumps on facial cheeks and neck that itch and feel irritated if I put on moisturi... Read more
Rash and small red bumps on facial cheeks and neck that itch and feel irritated if I put on moisturizer on my face.
32 2021-01-03 injection site pain, injection site redness, injection site warmth, injection site mass Injection site soreness, injection site red, hot and hard lump. Headache, fatigue, tiredness, chills
32 2021-01-04 injection site pain, skin warm 12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lighthe... Read more
12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lightheaded, fatigue, chills, mild nausea, stomach cramping, and muscle weakness all hit pretty hard at once. Notice slight arm soreness as well. Went back inside and essentially collapsed on the couch 5:30pm- Arm soreness is worse. Chills and lightheadedness only mild now. Fatigue has gone down to where I can resume daily activity 12/29 Wake up with moderate sore throat Stabbing arm soreness at injection site Moderate fatigue and nausea persist. Mild chills. Tried to go for a walk outside and found a 30 minute very slow walk extremely tough 12/30-1/2 Moderate sore throat continues. Other symptoms gone 1/1-2 Arm/ injection site soreness slowly fades 1/2: exercise for the day= 70 min yoga and 7.5 miles of walking. Had a couple glasses of wine at dinner (possibly relevant if issues with vaccine are related to high histamine food issues) 1/3 Moderate headache, fatigue, and muscle aches. Skin feels hot. Sore throat worse than the previous days. Mild runny nose. Severe nausea. Go to Urgent care for COVID test and Zofran Rx. COVID rapid test and PCR test both negative. No fever, higher than usual blood pressure 1/4-5 (current) Nausea lower but still moderate, requiring Zofran. Sore throat persists. Mild fatigue and muscle aches. Skin still feels warm. Mild vertigo during exercise
32 2021-01-04 hives, itchy skin Hives from head to toe, Itching really bad, nausea , and diarrhea Took Benadryl
32 2021-01-04 vaccination site pain chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp ... Read more
chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp of 100.8; This is a spontaneous report from a contactable nurse reporting for herself. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 21Dec2020 12:30 as a single dose (dose 1) in the left arm (age at vaccination: 32 years old) for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered wasa hospital. There were no other vaccines given in the 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with COVID-19 on 06Jul2020, irritable bowel syndrome (IBS), depression, attention deficit hyperactivity disorder (ADD), cervical spondylosis, and herpes simplex virus (HSV); no allergies to medications, food, or other products. Concomitant medication included methylphenidate hydrochloride (CONCERTA), sertraline hydrochloride (ZOLOFT), valacyclovir, levonorgestrel (LILETTA), and colecalciferol (VITAMIN D). The patient woke up at 0400 on 22Dec2020 with tympanic temp of 100.8, chills, body aches, and very tender left deltoid injection site pain. The events were reported as non-serious. Treatment with ibuprofen resolved the elevated temperature, however she spent all of 22Dec2020 with fatigue and body aches despite ibuprofen. The tender left deltoid persisted for a total of 3 days and then became more tolerable, less tender. The clinical outcome of elevated temp/ tympanic temp of 100.8 was resolved on 22Dec2020, of fatigue and body aches was recovered on 23Dec2020, and of chills and tender left deltoid was recovered on an unknown date. Since the vaccination, has the patient has not been tested for COVID-19.
32 2021-01-05 hives, redness, itchy skin 12/24 headache, low grade fever, chills took advil. 12/29 2:30am severe reaction of itching aggres... Read more
12/24 headache, low grade fever, chills took advil. 12/29 2:30am severe reaction of itching aggressively from scalp to toes, broke out in red hives, tachycardic Itchy throat, swollen, ears and lips.
32 2021-01-05 injection site discomfort Bronchospasm 1.5 hours post injection relieved by 1 puff of albuterol. 12 hours post injection heada... Read more
Bronchospasm 1.5 hours post injection relieved by 1 puff of albuterol. 12 hours post injection headache. 24 hours post injection chills, aches, malaise, low grade fever. Overall mild discomfort at the injection site.
32 2021-01-05 vaccination site pain Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; Diarrhea, chil... Read more
Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: Ek9231), via intramuscular route of administration, on 29Dec2020 at 08:45 AM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. Past drug history was allergy to Pediazole. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, at 07:30: AM, the patient experienced diarrhea, chills and vaccination site soreness. No treatment was received for the events diarrhea, chills and vaccination site soreness. The outcome of the events diarrhea, chills and vaccination site soreness was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
32 2021-01-05 hives, itchy skin Hives and itching 2 Benadryl (25mg tablets) Hives were gone in the morning but still some slight it... Read more
Hives and itching 2 Benadryl (25mg tablets) Hives were gone in the morning but still some slight itching
32 2021-01-05 itchy skin, rash Itching/rash, no medications given, patient went home on her own.
32 2021-01-05 injection site warmth, injection site redness, injection site mass, injection site pain, injection site pruritus, injection site swelling Recieved the Pfizer-Biontech Covid-19 vaccination on Dec 26th 2020, and had no major adverse reactio... Read more
Recieved the Pfizer-Biontech Covid-19 vaccination on Dec 26th 2020, and had no major adverse reaction to vaccine except for mild soreness and heat around injection site and intense fatigue for three days after. Symptoms went away after the 4th day. Two weeks later on Jan 5th 2021, i began to notice an intense itching, burning, and swelling at the injection site. Pain and soreness in arm made it difficult to do my job and seem to just get worse. Upon the next morning of Jan 6th 2021, pain remained but itching had gone down, but intense burning, soreness and massive redness around injection site remained and seemed to be getting worse. Pain remains and redness has not gone down, arm is very tender near site and lifting and moving arm is very stiff and sore. Feeling of lump or stiffness on injection site comes and goes and feeling of heavy and sore muscles move from upper left arm down to elbow and extend to hand; making movement and function slowed or slightly numb. Stiffness in arm and intense heat at injection site makes it uncomfortable to move or use arm. Cold tingling sensation on occasion and stiffness in elbow joint. Slight dizziness and fatigue follow with pain in arm. Was informed to see a physician on Jan 6th, 2021 who said to fill out vaccination adverse event report and to keep an eye on arm. If pain or symptoms become worse to return.
32 2021-01-05 rash, itchy skin The reaction I have now is its swollen face and neck area, rashes all over my body all very itchy sk... Read more
The reaction I have now is its swollen face and neck area, rashes all over my body all very itchy skin. Those are very manageable reactions. and happened exactly a week from the first dose of the vaccine. It has been going on for 2 days now and I will be seeing my doctor later today.
32 2021-01-05 itchy skin left side tingling and numbness, decrease BP and pulse, nausea, dizziness/lightheaded, difficulty an... Read more
left side tingling and numbness, decrease BP and pulse, nausea, dizziness/lightheaded, difficulty answering questions, itchy-allergic to benadryl so sent to ER for further evaluation
32 2021-01-06 redness, sensitive skin "My arm was sore for the first 24 hours, but the next morning I noticed that my hands were red. Oth... Read more
"My arm was sore for the first 24 hours, but the next morning I noticed that my hands were red. Otherwise I just felt tired, and my skin felt hypersensitive"
32 2021-01-06 hives Angioedema of the lips began about 14 hours after vaccine administration. Progressed to full facial ... Read more
Angioedema of the lips began about 14 hours after vaccine administration. Progressed to full facial swelling by 18 hours without respiratory compromise. Developed body urticaria. Resolved with time and oral prednisone.
32 2021-01-06 rash, hives Hives & rash on the anterior/posterior neck
32 2021-01-06 injection site swelling I started having swelling from the shoulder down, I had site soreness nausea vomiting headache chill... Read more
I started having swelling from the shoulder down, I had site soreness nausea vomiting headache chills fever body aches general malaise lack of appetite, worse than the flu symptoms. I still have some mile symptoms and chills on occasion. The worst of the symptoms is over. I took theraflu and hydrated I only went to the Dr for a note for work
32 2021-01-06 redness Started with fatigue, dizziness, red face, headache on 1/6/2021 Upon waking on 1/7/2021, Whole body ... Read more
Started with fatigue, dizziness, red face, headache on 1/6/2021 Upon waking on 1/7/2021, Whole body pains/ aches, soreness in all joints and worse on whole left side of body, extremely tired and headache
32 2021-01-07 injection site pain CHILLS, HEADACHE, BODY ACHE, SORE IN VACCINE AREA, NAUSEA, DIARRHEA,COUGH
32 2021-01-07 vaccination site pain, vaccination site redness, vaccination site warmth, vaccination site hardening Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot h... Read more
Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Chills; Headache; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 30Dec2020 14:45 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 20:00, the patient experienced injection site sore, red hot hard, chills, and headache. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter.
32 2021-01-07 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Adverse event: nausea, chills, injection site pain, tiredness, ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Adverse event: nausea, chills, injection site pain, tiredness, headache, muscle pain, feeling unwell Treatment: APAP 1000mg Q6Hrs Time course: injection site pain started ~3hrs after receiving vaccine; chills, headache started ~11-12hrs after vaccine; muscle pain, feeling unwell, nausea, tiredness started ~17-18hrs after receiving vaccine; majority of symptoms improved 48hrs after vaccine administration; some tiredness and feeling unwell remain
32 2021-01-07 injection site pain Unilateral facial edema/puffiness, fatigue, tenderness at the injection site
32 2021-01-08 injection site pain 1. Injection site pain: started soon after injection continued to get worse until 1 day after inject... Read more
1. Injection site pain: started soon after injection continued to get worse until 1 day after injection then progressively got better 2. Fever: t-max 38.2 orally noted at 0430 1/6/21. Fevers associated with chills and rigors at times. 3. Extreme joint and body aches: started early morning 1/6/21 and progressively got worse until 1/7/21 then got better with subsiding around 1/8/21. Pain preventing/limiting normal movements such as walking, turning, and weight baring. 4. Extreme fatigue: sleeping for 18-20 hours a day with hard to stay awake 1/6/21-1/8/21. Resolved by 1/9/21.
32 2021-01-08 itchy skin 1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T ... Read more
1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T - 98.1, HR - 91, RR - 16. Given 25 mg of oral benadryl per this RN per vaccination clinic standing order. 1403 - Pt reports feeling no change from initial report but does note "some finger tingling". 92% on RA, HR - 88. 1410 - Discussed taking a 2nd 25mg dose with patient. Will hold at this time, she states "my hands normally feel puffy when this gets worse but they feel normal now". Pt reports upper lip swelling feels "puffy" but unchanged from initial report. 1418 - Pt reports upper lip swelling increased, BP - 140/85, HR - 80, RR 16, 100% on RA, 25mg of oral benadryl given. 1423 - Pt reports upper lip "puffiness" with slight improvement, new c/o upper back itchiness, no rash or hives visualized on assessment 1428 - Pt reports improvement to feeling of "puffiness", back itchiness remains the same, and pt "feels sleepy" 1438 - Pt reports resolution of upper lip swelling and says "It feels like when I came in", slight back itchiness still present 1448 - Pt reassessed 30 min post 2nd dose of benadryl, pt reports complete resolution of all symptoms, BP - 135/79, T - 98.2, RR - 14, HR - 78, 100% on RA Discussed transportation with patient prior to providing 2nd dose of Benadryl, Pt home via private vehicle with mother (driver) and partner. Educated patient to call nurse on call number with any further concerns or if symptoms resume.
32 2021-01-08 hives Approx 5-6 hours after vaccination she felt an itchy throat and broke out in hives on chest and legs... Read more
Approx 5-6 hours after vaccination she felt an itchy throat and broke out in hives on chest and legs. She took benadryl and this resolved. Approx 24 hours later she started with sore throat and cough and mild SOB.
32 2021-01-08 injection site pain Fever, chills, headache, joint pain, injection site soreness, nausea, vomiting, muscle pain and weak... Read more
Fever, chills, headache, joint pain, injection site soreness, nausea, vomiting, muscle pain and weakness, abdominal pain. Difficulty getting out of bed and poor oral intake. Took 3000 mg acetaminophen and 500mg naproxen. Lasted 5am-7pm on 01/08/2021 currently severe side effects subsided to minimal side effects.
32 2021-01-09 itchy rash, rash with redness Erythematous and pruritic rash to BUE, chest and upper back
32 2021-01-10 redness 1/11 "less than 24 hrs, work Sunday night, hands were red, right one swollen. Continued on and off a... Read more
1/11 "less than 24 hrs, work Sunday night, hands were red, right one swollen. Continued on and off at work when benadryl and chlortabs started wearing off. As night continued y face is a little swollen, headache, hypersensitive skin, sore tired"
32 2021-01-10 itchy skin Currently pregnant, 23 weeks. 21 weeks at the time of injection. A little after an hour are receivi... Read more
Currently pregnant, 23 weeks. 21 weeks at the time of injection. A little after an hour are receiving injection itching began on jaw then progressed to other areas of the body. Arms, hands, belly, feet, head, and legs. Itching was not intense and could be ignored, no medication taken. Itching subsided after 24 hours but has returned on/off since. Message was sent to OBGYN asking for MD to contact me if he felt issue was urgent. No contact made but since issue persists will call and ask for lab work.
32 2021-01-10 injection site mass, itchy skin Swelling with localized fever, itching and quarter-silver dollar sized lump under skin after initial... Read more
Swelling with localized fever, itching and quarter-silver dollar sized lump under skin after initial swelling and lump at injection site had subsided
32 2021-01-10 itchy skin Vaccine at 600pm on 1/7. Waking up every hour from 330am-800am. Woke up 8am chest scratchiness/itchi... Read more
Vaccine at 600pm on 1/7. Waking up every hour from 330am-800am. Woke up 8am chest scratchiness/itchiness, generalized joint pain, and body aches, and fatigue. Episode of lightheadedness at around 6pm and near syncope. Started experiencing axillary swelling and pain. All symptoms resoled by 1/9 except for L axillary swelling which persisted until 1/11.
32 2021-01-10 injection site rash starting 12.5 hours post vaccine - chills, headache, body aches, nausea, rash at injection site, fat... Read more
starting 12.5 hours post vaccine - chills, headache, body aches, nausea, rash at injection site, fatigue. Chills and headache resolved after 24 hours. Other symptoms still present 36 hours later. Treated with tylenol.
32 2021-01-11 injection site pain Around 2pm on 1/9/21, I started to have mild abdominal discomfort. Later on that day started to have... Read more
Around 2pm on 1/9/21, I started to have mild abdominal discomfort. Later on that day started to have a headache. Took Tylenol 1gm, which helped with headache. Approximately at 1:45am on 1/10/21, I started to feel chills body aches, fatigue, abdominal pain, headache, arm pain on the injection site. Took Tylenol 1gm with Benadryl 50mg. Felt my body sweating. Woke up still with chills, and fatigue. Headache was intermittent throughout the day. Took Tylenol 1gm one time at night woke up on 1/11/21 without symptoms except for the arm pain.
32 2021-01-11 rash Dizziness, rash on legs , tiredness
32 2021-01-11 hives HIVES EXTENDING FROM BEHIND EARS TO LEGS. MORE PROMINENT ON ABDOMEN AND CREASE AREAS INCLUDING BOTH ... Read more
HIVES EXTENDING FROM BEHIND EARS TO LEGS. MORE PROMINENT ON ABDOMEN AND CREASE AREAS INCLUDING BOTH GROINS AND BEHIND KNEES.
32 2021-01-11 hives, itchy skin, redness Hive in legs and arms. Redness and itchy eyelids and ears.
32 2021-01-11 shingles, rash I experienced a rash shingles on 12/22/2020 the next day of vaccination. The rash lasted for a week ... Read more
I experienced a rash shingles on 12/22/2020 the next day of vaccination. The rash lasted for a week in a half. I seen my primary care doctor on 12/29/2020
32 2021-01-11 rash, rash with redness, rash papular I received the 2nd covid vaccine on thursday evening at 6:40pm. On the following Saturday I develope... Read more
I received the 2nd covid vaccine on thursday evening at 6:40pm. On the following Saturday I developed a red raised rash on the right side of my body, mostly arm and neck. I took 25mg benadryl. Rash lasted about 6h.
32 2021-01-11 injection site pain Left axillary lymph node swelling and pain lasting 3+ days, deltoid pain at injection site (2 days),... Read more
Left axillary lymph node swelling and pain lasting 3+ days, deltoid pain at injection site (2 days), general body aches, fatigue (3+ days).
32 2021-01-11 itchy skin Nausea, headache, itching, body aches.
32 2021-01-11 itchy skin, vaccination site pain, rash Rash; Minor swelling; Itching; Pain at the injection site; This is a spontaneous report from a conta... Read more
Rash; Minor swelling; Itching; Pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration from 24Dec2020 at single dose for covid-19 immunization. None medical history nor concomitant medications. It was reported that yesterday (03Jan2021) there was a rash with very minor swelling, itching, pain at the injection site. The outcome of events was unknown.
32 2021-01-11 injection site pain Vertigo, headache, muscle aches, injection site pain.
32 2021-01-11 rash, itchy skin within 1 hr post-vaccine on 1/7 I had a mild headache that resolved with Tylenol. At about 12 hours ... Read more
within 1 hr post-vaccine on 1/7 I had a mild headache that resolved with Tylenol. At about 12 hours post-vaccine I developed nausea, fever (100.4) and chills and secondary to this had poor sleep. The next day I took scheduled alternating Tylenol & ibuprofen during the day and then overnight 1 episode of chills that woke me up. no events Saturday or Sunday. Then Monday 1/11 in the early morning I started to develop a rash on my b/l elbow and right foot 3rd toe. I applied mometasone topical cream to these locations. while at work the rash extended down both forearms then by 5pm it was on both hips and extending along both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the itching woke me up. I repeated Benadryl 25mg at 8am. The rash seems to be getting better on the arms but then by noon I had a new breakout on my neck and face. I took Benadryl 50mg at 1pm. The rash continued to have a rapid progression over the next hour and resulted in angioedema with my throat swelling, lips puffed and numb and eye swelling. I was injected with an epi pen and sent to the ED where I received PO prednisone, famotidine, and Benadryl. The face/neck rash then greatly improved and I was sent home on prednisone 40mg daily for 3 days.
32 2021-01-12 itchy skin, hives 1/11- noticed itching on hips, 1/12: went swimming at 09:30 and noticed hives along hips and outer ... Read more
1/11- noticed itching on hips, 1/12: went swimming at 09:30 and noticed hives along hips and outer thighs, took 50 mg of Benadryl PO, checked O2- 95% on room air, no signs of shortness of breath; applied cortizone 10 to sites, 1/12 afternoon: hives lessening on hips and thighs but spread to armpits and elbows. Benadryl 50 mg PO taken at bedtime. 1/13: hives still present on hips, gone on armpits, spread to belly button and inner thighs. Will take another 50 mg of Benadryl PO and continue to monitor. New to area, no PCP at this time. However husband is ER nurse and I am also a nurse.
32 2021-01-12 itchy skin APPROXIMATELY 5 MINUTES AFTER VACCINATION, DEVELOPED ITCHINESS ON FOREHEAD AND NOSE. GAVE 25MG DIPHE... Read more
APPROXIMATELY 5 MINUTES AFTER VACCINATION, DEVELOPED ITCHINESS ON FOREHEAD AND NOSE. GAVE 25MG DIPHENHYDRAMINE AT 9:20AM, FOLLOWED BY 25MG AT 9:40AM. PATIENT STATED THIS WAS HER 'TYPICAL DOSE' AND WNET ON HER WAY BACK TO WORK AND STATED SHE FELT FINE.
32 2021-01-12 itchy skin About 24 hours after the vaccine injection felt like something stuck in throat and chest hurt. Progr... Read more
About 24 hours after the vaccine injection felt like something stuck in throat and chest hurt. Progressed in 30 minutes to pain in chest and head, swallowing painful, whole body and eyes itching and felt irritable. Symptoms continued for 24 hours.
32 2021-01-12 rash, shingles Low grade fever, body aches, lightheadedness and sore arm. Developed a localized rash that was later... Read more
Low grade fever, body aches, lightheadedness and sore arm. Developed a localized rash that was later diagnosed as shingles on 01/11/2021 by her PCP. A 01/04/202 COVID test was negative.
32 2021-01-12 rash Patient c/o a tingling in lips and rash over arm. Patient taken immediately to ER to be seen.
32 2021-01-12 injection site redness, injection site pruritus Pt received Dose 1 of COVID vaccine. Nurse checked on patient five minutes post injection and patien... Read more
Pt received Dose 1 of COVID vaccine. Nurse checked on patient five minutes post injection and patient reported that she was having some itching at the site. Patient advised would continue to monitor. Slight reddness no raised rash. Checked on patient at 1100, patient asked about soreness of her throat. Patient states that it had just started approx five minutes prior. Patient reports lump sensation in her throat "like something in throat when have cold." PA-C and RN came in for observation and eval. Decided patient to come to urgent care for futher medical eval and observations. Vitals monitored before leaving and WNL (see chart). Patient ambulated per self to urgent care with provider and nurse. At convenient care, pt reports scratchy throat and feels like "something" is in her throat. Denies SOB or cough. Uvula appears slightly swollen, but no previous exams for comparison. Pt given diphenhyramine 25 mg IM x 1 and 15 minutes later she reported mild improvement in swelling, but no change on exam. 45 min after Benadryl she reported feeling tired but improvement in symptoms. Uvula appeared to be smaller on re-examination. Instructed to take 50 mg Benadryl Q 6 hours for the next day. Discharged to home with perscription for albuterol 90 mcg/inh 2 puffs Q6hrs PRN
32 2021-01-12 rash Rash on back of neck around neck arms and back told by 2 drs it was linked to the covid vaccine 7 da... Read more
Rash on back of neck around neck arms and back told by 2 drs it was linked to the covid vaccine 7 days ago.
32 2021-01-12 injection site pain, injection site redness Subcutaneous injection on the back o f the right arm. Was red/sore/painful - widespread redness on ... Read more
Subcutaneous injection on the back o f the right arm. Was red/sore/painful - widespread redness on arm from elbow to scapula. Took 500mg Tylenol
32 2021-01-12 injection site pain Tired and dizzy within 10min, lasted for 7 hrs until bedtime. The next morning, no longer dizzy but ... Read more
Tired and dizzy within 10min, lasted for 7 hrs until bedtime. The next morning, no longer dizzy but full body joint pain/ache and injection site pain/ache.
32 2021-01-12 redness, skin burning sensation tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to ri... Read more
tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to right wrist; joint pain and swelling to right wrist; swollen lymph node on right side of body; weakness; skin redness and burning sensation; skin redness and burning sensation; tremors; gum pain; fatigue; migraine; sweating; back pain; first dose of bnt162b2 on 18Dec2020 at 16:00, second dose on 04Jan2021 at 08:00 AM; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELU140), via an unspecified route of administration on 04Jan2021 at 08:00 AM on Right arm at single dose for COVID-19 immunization. The patient medical history included had known allergies with Penicillin, bees and wasp. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol, retinol (VITAMIN A); colecalciferol (VITAMIN D); calcium phosphate dibasic, phytomenadione (VITAMIN K); cyanocobalamin (VITAMIN B12); levothyroxine, liothyronine (NP THYROID). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 18Dec2020 at 16:00 on Right arm at single dose for COVID-19 immunization. The patient experienced fever above 101, tachycardia (140 bpm), myalgia, joint pain right arm, joint pain and swelling to right wrist, swollen lymph node on right side of body, weakness, skin redness and burning sensation, tremors, gum pain, migraine, fatigue, sweating and back pain, all on 04Jan2021 at 20:00, events were resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. It was unknown if any treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
32 2021-01-13 injection site redness, injection site swelling 01/09/21 woke up with Mirgraine, nausea, dizziness with standing and reports inability to eat, flus... Read more
01/09/21 woke up with Mirgraine, nausea, dizziness with standing and reports inability to eat, flush feeling, night sweats, body aches, tired, fatigue, lymph node tenderness under both arms and arm at injection site was red and swollen about the size of a baseball. Slept most of the day and still did not feel well when woke up later in the day and called into work evening of 01/09/21. Reports when she woke up the morning of 01/10/21 felt great.
32 2021-01-13 hives, rash with redness No issues at first, but around 4pm I started getting hives on my chest. Very red and bumpy. I'm not ... Read more
No issues at first, but around 4pm I started getting hives on my chest. Very red and bumpy. I'm not having any difficulty breathing, so I think I'm fine.
32 2021-01-13 injection site pain On 1/12 I started feeling weak, tired, sore on the injection site. On 1/13 I started feeling dizzy a... Read more
On 1/12 I started feeling weak, tired, sore on the injection site. On 1/13 I started feeling dizzy and I?m having headache and nausea and I still feel those symptoms now.
32 2021-01-13 injection site pruritus, injection site swelling, injection site pain PAIN ON INJECTION SITE, HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, SWELLING ON INJECTION SITE, NAUSIA, FE... Read more
PAIN ON INJECTION SITE, HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, SWELLING ON INJECTION SITE, NAUSIA, FEELING BAD, INCHING ON INJECTION SITE. ONE DAY OF SINTOMES.
32 2021-01-13 injection site swelling, injection site pain, injection site pruritus PAIN ON INJECTION SITE,HEADACHE ,TIRED MUSCULAR PAIN,CHILLES,SWELLING AREA OF INYECCTION,FEELING BAD... Read more
PAIN ON INJECTION SITE,HEADACHE ,TIRED MUSCULAR PAIN,CHILLES,SWELLING AREA OF INYECCTION,FEELING BAD, AND INCHING IN INJECITION AREA.
32 2021-01-13 vaccination site pain Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated ... Read more
Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated down to elbow and thumb; Intense body aches; chills; This is a spontaneous report from a contactable other nurse (patient). A 32-year-old female patient received the first dose of BNT162b2 (Lot number: EK9231), via an unspecified route of administration at right arm on 04Jan2021 13:30 at single dose for covid-19 immunization. Medical history included birth control. Concomitant medication included probiotics, ethinylestradiol, norethisterone acetate (JUNEL) for birth control. The patient experienced soreness at injection site on 04Jan2021 18:00; soreness radiated down to elbow and thumb, Intense body aches, joint pain, chills on 04Jan2021. The patient received the treatment Acetaminophen 1000mg every 6 hours and Ibuprofen 400mg for events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
32 2021-01-13 injection site pain, injection site inflammation Upon injection I experienced immediate pain throughout the entire vaccine, which I did not experienc... Read more
Upon injection I experienced immediate pain throughout the entire vaccine, which I did not experience with the first dose. I had inflammation around the deltoid muscle and the following day I had pain and soreness that traveled up my trapezius muscle into my neck with some slight neck stiffness and a large lump over my collar bone on that side at the base of my neck. The lump is quite painful to even gentle touch. I also have pain at the site with movement of my left arm, which was the injection site.
32 2021-01-13 vaccination site pain injection site pain; tiredness; headache; muscle pain; chills; nausea; feeling unwell; This is a spo... Read more
injection site pain; tiredness; headache; muscle pain; chills; nausea; feeling unwell; This is a spontaneous report from a contactable pharmacist (patient). This 32--year-old female pharmacist reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK9231/expiration date: unknown), via intramuscular route of administration, on 06Jan2021 at 09:30 AM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history was not provided. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XR) 300mg daily, levothyroxine 25mcg QAM and prenatal vitamin one-a-day. The patient previously received the first dose of BNT162B2 (lot number: EH9899/expiration date: unknown) on 16Dec2020 at 09:30 AM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 at 09:00 PM, after the second dose, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell. Treatment was received for the events injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell included Acetaminophen 1000mg Q6Hrs. The outcome of the events injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell was unknown. Since the vaccination, the patient had not been tested for COVID-19.
32 2021-01-13 vaccination site pain mild muscle aches; Injection site soreness; feverish; headache; insomnia; restlessness; This is a sp... Read more
mild muscle aches; Injection site soreness; feverish; headache; insomnia; restlessness; This is a spontaneous report from a contactable Physician reporting for herself. A 32-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration, in left arm, on 07Jan2021 at 11:15 at single dose for COVID-19 immunisation. Age at vaccination was 32 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) was received via an unspecified route of administration on 21Dec2020 at 09:00 in left arm at single dose. Medical history included major depression, and generalised anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) and daily fusion multivitamin. On 08Jan2021 at 01:00 AM the patient experienced injection site soreness, feverish, headache, insomnia, restlessness, mild muscle aches. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the events was unknown.
32 2021-01-14 hives, itchy skin As I was awaiting my 30 minute monitoring I began to itch all over my body. I began to get hives on ... Read more
As I was awaiting my 30 minute monitoring I began to itch all over my body. I began to get hives on my face, arms, legs, and stomach. I felt ill and could not stop itching.
32 2021-01-14 injection site redness, injection site swelling Dizziness, body ache, fatigue, nausea, swelling/redness around injection site. Resolved.
32 2021-01-14 vaccination site warmth Hot injection site; sore arm; swollen lip; nausea; This is a spontaneous report from a contactable ... Read more
Hot injection site; sore arm; swollen lip; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 08Jan2021 07:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient's historic vaccine included Other Pfizer vaccine on 18Dec2020. The patient experienced hot injection site, sore arm, swollen lip, nausea on 09Jan2021 15:00. Therapeutic measures were taken as a result of events included Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. Information on Lot/ Batch number has been requested.
32 2021-01-14 shingles Several days after the first dose, I developed shingles and needed medical attention for this. 12 ho... Read more
Several days after the first dose, I developed shingles and needed medical attention for this. 12 hours after the second dose, I developed fevers, chills, rigors, body aches for 5-6 hours.
32 2021-01-14 itchy skin Shortness of breath, extreme itching, full body flushing, chest pain, weakness.
32 2021-01-14 injection site warmth, injection site hardening, injection site redness, injection site pain Swollen lymph node under right arm, injection site red, warm, raised and hard. very painful at site.
32 2021-01-14 skin warm, dry skin patient c/o feels like heart racing, denies shortness of breath, HR regular, skin warm and dry, teet... Read more
patient c/o feels like heart racing, denies shortness of breath, HR regular, skin warm and dry, teeth chattering, patient states they feel cold, monitored for 45 minutes, patient left at 1147 states she is ready to go, states I am ok.
32 2021-01-15 injection site pain Pregnancy history: early pregnancy, 5 weeks. Symptoms included pain at injection site, mild muscle a... Read more
Pregnancy history: early pregnancy, 5 weeks. Symptoms included pain at injection site, mild muscle aches, and fatigue. Symptoms starting about 12 hours after shot. 500mg tylenol taken twice.
32 2021-01-15 injection site pain Severe soreness in left upper arm at location of the shot about 5 hours after the shot, the pain ext... Read more
Severe soreness in left upper arm at location of the shot about 5 hours after the shot, the pain extended into the armpit/lymph area of my left arm and the pain remained steadily severe until Friday 1/15- 3 days after the initial injection. At 1pm on day of shot (1/12/21) had feelings of chills, sweaty and whole body aches. This lasted until Thursday morning 1/14 around 7am. During that time, took Tylenol for the aches and feverish feelings. Arm soreness finally subsided Friday. migraines started Thursday evening into Saturday morning. With little relief from Imitrex (prescription medication for chronic migraines). Went to the emergency room Saturday for a shot of Torodal for the migraine to subside.
32 2021-01-16 injection site swelling 12 hours following injection, I developed fever in mid 101 F along with flu-like symptoms of chills,... Read more
12 hours following injection, I developed fever in mid 101 F along with flu-like symptoms of chills, body aches, headache. 24 hours after injection, I developed swollen and tender lymph node under my left underarm (the same arm that received the shot). 48 hours after injection, I had horrible night sweats needing to change out of drenched pajamas every 1.5 hours.
32 2021-01-16 itchy skin Burning and itchiness after Injection which went away within an hour. Several hours later I became v... Read more
Burning and itchiness after Injection which went away within an hour. Several hours later I became very disoriented, dizzy, flush, sevwr headache, diahhrea, nauseous (dry heaving), extremely achy in arm , neck and shoulder. Some symptoms are still present 36/hours later.
32 2021-01-16 itchy rash, hives This was the second dose given 2 weeks after the first dose. Itchy rash and hives and swollen eyes 2... Read more
This was the second dose given 2 weeks after the first dose. Itchy rash and hives and swollen eyes 2 days after vaccine.
32 2021-01-17 redness, hives 1/8/21 DURING DAY: FATIGUE AND HEADACHE STARTED; DURING EVENINGS: CHILLS, BODYACHES, JOINT PAIN, SOR... Read more
1/8/21 DURING DAY: FATIGUE AND HEADACHE STARTED; DURING EVENINGS: CHILLS, BODYACHES, JOINT PAIN, SORE THROAT, AND FEVER (100.9 WHILE ON EXTRA STRENGTH TYLENOL). SATURDAY MORNING: RED, HOT, WELT (ITCHY AT TIMES) AND STOMACH ISSUES. TOOK ADVIL AND EXTRA STRENGTH TYLENOL.
32 2021-01-17 vaccination site pain Injection site tenderness for first 24 hours; swollen lymph glands; This is a spontaneous report fro... Read more
Injection site tenderness for first 24 hours; swollen lymph glands; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 18Dec2020 11:00 at single dose for COVID-19 immunization. Medical history included tumor removal from left thigh and depression. The patient had no known allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), drospirenone, ethinylestradiol (OCELLA), clonazepam, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 02Jan2020, patient reported injection site tenderness for first 24 hours. In less than 24 hours she had developed tenderness under her left arm, into her armpit and it continued to spread downward and also toward her breast. Patient also developed swollen lymph glands in the same areas. No treatment received in response to the events. The patient had no COVID prior to vaccination and not COVID tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were reported as non-serious. The patient received her second dose of bnt162b2 on 08Jan2021 11:00 in the left arm. Outcome of the events was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
32 2021-01-17 skin spots, rash Petechial rash developed on bilateral lower extremities. Nonpuritic. Coalesced into purpural lesions... Read more
Petechial rash developed on bilateral lower extremities. Nonpuritic. Coalesced into purpural lesions on the bilateral posterior knees. Rash resolved within one week.
32 2021-01-17 rash Purpura on abdomen
32 2021-01-17 injection site swelling, injection site pain Starting with headaches, injection site soreness, swollen lymph nodes in arm of injection, treated b... Read more
Starting with headaches, injection site soreness, swollen lymph nodes in arm of injection, treated by ibuprofen, about 12 hours after the vaccine About 16 hours after the vaccine fever, chills, muscle aches, nausea, vomiting, headaches, lymph node soreness lasting 12+ hours 2nd day after vaccine intense fatigue and headaches, arm and lymph node soreness 3rd day after the vaccine , headaches and arm/lymph node soreness 4th day after the vaccine, arm and lymph node soreness
32 2021-01-17 hives, rash TM stated she developed temp of 101 and her back and under her breast line she has developed hives. ... Read more
TM stated she developed temp of 101 and her back and under her breast line she has developed hives. Took Tylenol for the temp , saw her PMD. She was given Calamine lotion for the hives as she says she is allergic to Benadryl.
32 2021-01-17 rash, injection site redness, injection site pain tachycardia, arm pain, erythema, swelling; facial flushing/burning; fatigue, rash On 1-14-21 she tes... Read more
tachycardia, arm pain, erythema, swelling; facial flushing/burning; fatigue, rash On 1-14-21 she tested +for Covid
32 2021-01-17 injection site redness, rash macular, injection site swelling, rash tightening of my chest and throat, wheezing, swelling and irritation in back of tongue and lips, ras... Read more
tightening of my chest and throat, wheezing, swelling and irritation in back of tongue and lips, rash/ skin bloching on face and chest bilaterally, injection site swelling and redness.
32 2021-01-18 injection site swelling, injection site redness -fever (up to 103F) x 11 days -chills x 11 days -muscle/body aches x 11 days -fatigue x 11 days -swo... Read more
-fever (up to 103F) x 11 days -chills x 11 days -muscle/body aches x 11 days -fatigue x 11 days -swollen lymph node x 10 days -rash (red, raised, dry/scaly) on bicep area of left arm (same arm as injection site) x 11 days -nausea/diarrhea x 3 days (starting on 1/18/21) -decreased appetite x 2 days (starting on 1/18/21)
32 2021-01-18 itchy skin, hives 12/24 headache, low grade fever, chills took advil 12/29 2:30am severe reactionof itching agressiv... Read more
12/24 headache, low grade fever, chills took advil 12/29 2:30am severe reactionof itching agressively from scalp to toes, broke out in Red Bumpy Hives, Heart RateFaster, Itchy throat, swollen, ears and lips
32 2021-01-18 injection site warmth, injection site redness, injection site hardening, injection site swelling Evening post injection- red, swollen, warm and hard at injection site; morning post injection: fever... Read more
Evening post injection- red, swollen, warm and hard at injection site; morning post injection: fever of 101.0, chills, nausea, joint pain, muscle pain, fatigue.
32 2021-01-18 injection site swelling, injection site pain Fever of 101.8, chills, and pain and mild swelling at injection site all lasting around 24 hours.
32 2021-01-18 blister, injection site pain, shingles Had sore arm and felt unwell shortly after receiving the shot. The following morning my arm was stil... Read more
Had sore arm and felt unwell shortly after receiving the shot. The following morning my arm was still sore and I developed a blister behind my left ear and swollen lymph-nodes. The soreness in my arm went away however the blister became worse and started erupting with puss and the lymph-node became larger, tender, and developed sharp . shooting pain. I went to urgent care on 1/3/2020 and was given oral antibiotics and an antibiotic cream for the blisters. A swab culture was taken for possible shingles. On 1/4/20 I went to clinic as the pain had worsen and resulted in a numbing sensation on my left cheek. The doctor prescribed me antivirals for Shingles and I was given an antibiotic shot in the butt. I was off work for two weeks. The pain went away around 1/15/20. The blisters are healed.
32 2021-01-18 vaccination site swelling Headache; chills; Feel empty; Diarrhea; Aches and pain; I cannot move my arm barely with where I got... Read more
Headache; chills; Feel empty; Diarrhea; Aches and pain; I cannot move my arm barely with where I got the shot at; I got the shot at and I looked my arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 07Jan2021 12:00 in the arm at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included paracetamol (TYLENOL). The patient stated, "I just wanted to report some side effects. I am on my second dose now and I am having (incomplete sentence), first of all, I had diarrhea as of last night in Jan2021. I had chills all way down to my bones as of yesterday like almost immediately after I received the shot. I feel empty, I got chills on 07Jan2021. I had a slight headache this morning on 09Jan2021 and I am also dealing with a lot of aches and pain however just now because I cannot move my arm barely with where I got the shot at and I looked my arm was swollen in Jan2021." The outcome of the events was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Information about Lot/Batch number is requested.
32 2021-01-18 rash Red bumps/spot on face and neck
32 2021-01-18 itchy skin, rash with redness headache; earache; cough; chills; entire body aches/soreness; itchy red swollen rash on palms of han... Read more
headache; earache; cough; chills; entire body aches/soreness; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; right ear swelling/itching; right ear swelling/itching; This is a spontaneous report from a contactable Other HCP (patient). This 32-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 at single dose (lot number: e13246) for covid-19 immunisation. Medical history included PCOS, HSV2, ADHD, anxiety, depression. Concomitant medications included atenolol (NORTELOL), spironolactone, valaciclovir (VALACYCLOVIR), bupropion. The patient previously received erythromycin and experienced allergies, received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) at left arm on 14Dec2020 04:00 P.M for covid-19 immunisation. The patient experienced headache, earache, cough, chills, entire body aches/soreness, fatigue, Right arm pit tender/sore, itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching on 09Jan2021 12:00 A.M. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovering.
32 2021-01-18 vaccination site itchiness, vaccination site redness, vaccination site swelling migraine; weakness; itchiness, redness and swelling around the injection site; itchiness, redness an... Read more
migraine; weakness; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; This is a spontaneous report from a contactable nurse. A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 30Dec2020 at SINGLE DOSE at left arm for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. On 30Dec2020, the patient reported migraine and became more severe on 31Dec2020, weakness, itchiness, redness and swelling around the injection site post vaccination. Caller wants to know if she can receive the second dose of the vaccine despite the redness and swelling around the injection site. The outcome of the event Itchiness, red and swollen injection site was recovered on 31Dec2020, the event migraine, weakness was recovered on 01Jan2021 Information about Lot/Batch number has been requested.
32 2021-01-18 hives, itchy skin on 1/17/21 I was at home watching a movie around 6:00pm started itching and eyes started swelling wh... Read more
on 1/17/21 I was at home watching a movie around 6:00pm started itching and eyes started swelling when to the bathroom to look and I had hives all over my upper body. I have not changed in anything in my house or tried any new food. I took some Pepcid and a cold shower. in about an hour the itching stopped but I was still red. went to bed then when I woke up the next morning my hands was so swollen I couldn't move my fingers and they was numb, itching and hurting all at the same time. so i went to the clinic. they gave me a steroid shot, Benadryl, Pepcid and Claritin. my hands started to go down some before i left the clinic. not i have to take all the meds the next 3 days. still on 1/19/21 @ 6:00am my face started to flush before i took my meds.
32 2021-01-18 injection site hardening reporting what she terms a pocket under the skin where the shot was given. She states it is deep an... Read more
reporting what she terms a pocket under the skin where the shot was given. She states it is deep and hard and feels like it is not absorbing. This happened with her B12 shot as well.
32 2021-01-19 injection site pain 0710 January 19th I received the second does of the Covid -19 vaccine. The site was very sore all da... Read more
0710 January 19th I received the second does of the Covid -19 vaccine. The site was very sore all day. Around 2230 that night, I started having intermitted sharp pain in my leg arm pit. 0430 January 20th I woke up with sharp pains still in my left arm pit. By 1030 the pain was now constant and extreme. I called my doctor and he told me to come into the office to see him. NP saw me and explained that the lymph nodes in my left arm were swollen. Very tender to touch also. He prescribed me Prednisone twice a day for three days, Ibuprofen, and use hot compresses. So far the pain has gotten better.
32 2021-01-19 rash, vaccination site pain High fever every 3 hours; I got a rash; Vomiting; Very Bad Headache; Joint pain; Fatigue; Pain in In... Read more
High fever every 3 hours; I got a rash; Vomiting; Very Bad Headache; Joint pain; Fatigue; Pain in Injection site; Lymph nodes swelling and pain; Lymph nodes swilling and pain; received the first dose on 18Dec2020 and the second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3746), via an unspecified route of administration on the left arm on 06Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient has no known allergies. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on the left arm on 18Dec2020 at 07:30 at a single dose as COVID-19 immunization. The patient had no other vaccine in four weeks, no COVID prior vaccination, and did not test post-vaccination. The patient had a rash, high fever every 3 hours, vomiting, very bad headache, joint pain, fatigue, pain in injection side, lymph nodes swelling and pain on 08Jan2021 at 12:00. No treatment was administered for the events. The events were resolving.
32 2021-01-19 skin infection at injection site I had the typical reactions: fever, headache, chills, fatigue but then got cellulitis right below in... Read more
I had the typical reactions: fever, headache, chills, fatigue but then got cellulitis right below injection site.
32 2021-01-19 injection site swelling Vaccine given on Friday 1/8 at 10am. Started having significant fevers, chills, myalgias, rigors on ... Read more
Vaccine given on Friday 1/8 at 10am. Started having significant fevers, chills, myalgias, rigors on 1/9 around 1pm. Symptoms lasted for about 8hrs. On 1/10 developed left upper arm, axillary, chest wall, and clavicular soft tissue swelling with significant lymphadenopathy. Lymphadenopathy was tender, multiple nodes ~2cm. Started experiencing severe sharp shooting pain and burning in similar region. On 1/11 started developing weakness in L arm and hand, with numbness in left hand. Went to urgent care on 1/11. Exam demonstrated 4/5 strength of left arm and hand. Started prednisone 40mg on 1/11. Swelling, pain, and weakness persisted. Seen in ER 1/15, exam with persistent weakness and lymphadenopathy. MRI brachial plexus performed which showed multiple enlarged nodes adjacent to brachial plexus. No overt inflammation or compression of brachial plexus. Received IV dexamethasone, and PO prednisone course. Finished 10d of prednisone 40mg with improvement in soft tissue edema, but still with residual weakness and pain. EMG pending. Diagnosed with brachial plexopathy secondary to compressive adenopathy from COVID 19 vaccine.
32 2021-01-19 vaccination site pain interrupt sleep throughout the night; mild body aches; lightheadedness; fatigue; slight headache; in... Read more
interrupt sleep throughout the night; mild body aches; lightheadedness; fatigue; slight headache; injection site soreness; Chills; fever; This is a spontaneous report from a contactable pharmacist (patient) and a contactable other health professional. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), on 17Dec2020 at 14:30 and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 08Jan2021 at 12:30, each via an unspecified route of administration at right arm at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included bupropion XL at 150 mg. On an unspecified date, the patient experienced 12 hrs. after vaccine administration, chills and subjective fever began and lasted approximately 24 hrs. (until 36 hrs. post-vaccine) severe enough to interrupt sleep throughout the night. Mild body aches during this time, along with lightheadedness, fatigue, slight headache and injection site soreness. The patient didn't receive any treatment. The patient outcome of the events was recovered.
32 2021-01-20 injection site pain, injection site redness, injection site swelling, itchy skin, injection site discolouration, cellulitis, skin warm, injection site mass Got the shot on a Tuesday, had normal side effects (swelling, redness, pain at site). Those side eff... Read more
Got the shot on a Tuesday, had normal side effects (swelling, redness, pain at site). Those side effects were gone by Saturday. Noticed some discoloration of the injection site on Sunday/Monday. By Monday night a small lump and redness had reappeared. Tuesday morning the lump had gotten bigger and hot to the touch, itchy as well. Wednesday even itchier and bigger and hotter. Went to urgent care and was given cephalexin for cellulitis. Today is a Thursday, the itchiness has gone down but the lump is much bigger and still warm to the touch.
32 2021-01-20 hives Hives to upper body, neck and face within 10-15 minutes of getting the vaccination at 4:00 pm. Sent ... Read more
Hives to upper body, neck and face within 10-15 minutes of getting the vaccination at 4:00 pm. Sent to the ER. Given IV solu-medrol, Pepcid and Benadryl. Was rechecked after about 45 minutes and rash had not improved, so was given Decadron. Waited another 45 minutes and rash was finally fading. Was discharged around 7 pm. Went home and took 50 mg Benadryl. The next morning the rash had resolved.
32 2021-01-20 injection site pain I received the first dose of vaccine on 12/17/20 with no symptoms initially other than soreness at i... Read more
I received the first dose of vaccine on 12/17/20 with no symptoms initially other than soreness at injection site. 4-5 days post vaccine I began to have mild sinus drainage, headaches, and backaches that I attributed to allergies, stress, and sinus issues. On the evening of 12/23/20, I had lost my sense of smell completely and had diminished taste. I was tested for COVID-19 around 0830 the next morning on 12/24/20 and was positive for the virus. That day and the 7-8 days that followed I was extremely fatigued with muscle aches. I continued to participate in the V-safe surveys and made note that I was having these symptoms likely because I was positive for COVID-19 (as of 12/24/20). The CDC called and I relayed this information to them and it was decided that a report was not necessary. After my second dose of vaccine on 01/07/21, I received another call from the CDC and it was recommended that I do file a report so data could be collected on those who have tested positive for COVID-19 after the initial vaccine. I had no significant symptoms after my second vaccine and have presumably fully recovered from the virus to date.
32 2021-01-20 vaccination site pain Mild myalgias 36h after on 19Dec2020 02:30; Intermittent mild Dizziness and nausea 24h after vaccine... Read more
Mild myalgias 36h after on 19Dec2020 02:30; Intermittent mild Dizziness and nausea 24h after vaccine; Intermittent mild Dizziness and nausea 24h after vaccine; Pain at side of puncture, unable to lift arm from 12h to 40 hours after; unable to lift arm from 12h to 40 hours after; This is a spontaneous report from a contactable Physician(patient). A 32-year-old female patient received first dose BNT162B2 (lot number EH9899) , via an unspecified route of administration at Arm Right on 17Dec2020 14:30 at the 32 years old at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medication was levothyroxine. The patient experienced Pain at side of puncture on 18Dec2020 12:00, unable to lift arm from 12h on 18Dec2020 02:30 to 40 hours after on 20Dec2020 06:30, Intermittent mild Dizziness and nausea 24h after vaccine on 18Dec2020 14:30, Mild myalgias 36h after on 19Dec2020 02:30, resolved at 48h post vaccine on 19Dec2020 14:30. There was no treatment received for all the adverse events. There was no other vaccine in four weeks. The outcome of the events was Recovered.
32 2021-01-20 injection site pain Monday 4pm was vaccinated. Left arm. Tuesday morning felt ?icky? but went to work. My left arm was s... Read more
Monday 4pm was vaccinated. Left arm. Tuesday morning felt ?icky? but went to work. My left arm was sore at the injection site but no rash. Wednesday morning I woke up with slight shortness of breathe, and felt some wheezing, horrible headache right behind my eyes, hot flashes, I felt like the inside of my body was on fire. No temperature. My body all around ached. My stomach was extremely upset. I had loose stools multiple times through out the day. When I tried to drink anything my stomach felt like it was also ?on fire? it was just not happy with anything being in there. Thursday same way. Headache, muscle aches, I am so tired. I feel drained of energy. My stomach is extremely upset. I have not ate anything since Tuesday afternoon. I have drank a lot of water. My body still ?aches? I have had loose stools.
32 2021-01-21 hives Four days after she received the 1st dose, she developed a swollen eye lid that resolved on its own... Read more
Four days after she received the 1st dose, she developed a swollen eye lid that resolved on its own. She really didn?t think anything of it and did not report it to anyone or take any medication for it. On 1/12/2021 she received the 2nd dose. On day 7 of her vaccine she developed hives on her lower extremities. She took Benadryl that day and they improved, but did not got away. On day 8 the hives reapproved and she took a dose of Claritin and that got her through working. On day 9 (yesterday) the hives have migrated from just her lower extremities to her arms and shoulders. She took both Zyrtec and Benadryl yesterday, but she is not getting any relief.
32 2021-01-21 hives I had the first vaccine with no adverse side effects and had no adverse side effects right after the... Read more
I had the first vaccine with no adverse side effects and had no adverse side effects right after the second dose but approximately 2 or 3 days after I had facial swelling about my eye lids. Then, the evening of 1/20, I developed hives all over both legs. They were still there the next morning and I took Benadryl and later loratadine and they eventually went down. Later in the evening on 1/21 they came back so I took a Zyrtec and the next morning they were worse and were on my legs and arms and shoulders. I called employee health and the doctor directed me to take Zyrtec twice daily and also to take a Pepcid daily. At this point in the afternoon on 1/22, I still have the hives but they seem to be slightly improving as the day goes on.
32 2021-01-21 itchy skin PRE-DOSED WITH 10ML ORAL DIPHENHYDRAMINE LIQUID DUE TO REPORTED REACTION TO 1ST COVID VACCINE DOSE. ... Read more
PRE-DOSED WITH 10ML ORAL DIPHENHYDRAMINE LIQUID DUE TO REPORTED REACTION TO 1ST COVID VACCINE DOSE. APPEARED FLUSHED IN THE FACE AND NECK WITHIN 5 MINUTES OF VACCINATION AND REPORTED FEELING ITCHY. NO HIVES NOTED AND NO DIFFICULTY BREATHING REPORTED UPON QUESTIONING.
32 2021-01-21 redness, rash macular Pt entered observation @ 09:42 AM. At 09:52 AM, patient came up and stated that she felt "light-head... Read more
Pt entered observation @ 09:42 AM. At 09:52 AM, patient came up and stated that she felt "light-headed", and that her HR was 150. This nurse explained to patient that she needed to sit back down r/t the "light-headedness". Asked patient if she would like some water patient stated "no, she was ok". At 09:56 AM, the nurse noticed "red blotches" to neck of patient. This nurse walked patient to bed in observation room. Denies SOB nor troubled breathing. Benadryl 25mg was given PO @ 09:56 AM. V/S obtained @ 10:02 AM. BP-120/80, P-124, R-18, O2-99. Still voices no s/s of SOB nor troubled breathing. States to this nurse that she had an "anaphylactic reaction" to lobster years ago, in which she did not state this upon receiving the vaccinations. Also has allergies to Zofran and Macrolides. Pt remains in observation @ present time @ 10:06 AM. Redness remains to neck and upper BL arms. Remains in observation @ 10:30 AM. S/S somewhat alleviated, no lightheadness, but does voice nausea. Stated that she only at a "Granola Bar" this morning. HR remains between 97-114. V/S taken @ 10:39 AM BP-118/76, P-98, R-18, 02-99. Remains in observation @ present time. Time is 10:47 AM. S/S of feeling better @ 10:52 AM, remains in observation. Will call an Uber home, will remain in observation until Uber arrives. Denies SOB nor troubled breathing.
32 2021-01-21 injection site rash, rash Rash immediately following injection. Started at injection site and went up neck, down back. Went ... Read more
Rash immediately following injection. Started at injection site and went up neck, down back. Went to ED and was given Solu Medrol, Benadry, Pepcid, Decadron. Took Benadryl 50 mg by mouth that evening. Rash resolved by next morning.
32 2021-01-21 injection site swelling, injection site pain Swelling axillary lymph node in injection arm and pain.
32 2021-01-21 injection site rash, rash Symptoms: Patient complaining of rash to face, neck and hand for the last 10-15 minutes. States th... Read more
Symptoms: Patient complaining of rash to face, neck and hand for the last 10-15 minutes. States that they look like hives and have a burning sensation. Had 2nd COVID vaccine about 3 hours ago. Denies any breathing difficulty. Is a 32 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine. Second Dose in Series: Vaccine was obtained from the following clinic/location: Butterworth on the date of: 1/18 and approximate time of 7pm Vaccine was administered to patient's: Left Deltoid Vaccine manufacture was: Pfizer No Previous Reactions to other immunizations Known COVID Exposure since receiving vaccination?: No Patient notes the following symptoms: Rash: Location other than injection site face neck and hands - burning sesation Modifying Factors or additional details:Around 3 1/2 hrs post vaccine she started to break out in a rash on hands and face. She denies any other changes to her environment. Took benadryl and this seemed to help. ROS
32 2021-01-21 skin warm Was given vaccine at a clinic with EMS present. Approximately 5 minutes after the injection she sai... Read more
Was given vaccine at a clinic with EMS present. Approximately 5 minutes after the injection she said she felt lightheaded/dizzy first, some dizziness, with slight tingling of the tongue. Said her legs felt tingling, hot and hands shook. She said throat felt slightly tight. EMS was on sight and they administered her Solumedrol and Benadryl IM. She was never given an epi injection. They monitored her HR and O2 Sats. After she felt symptoms were resolved she did leave the clinic on her own accord. She returned to her work even though she was advised to go home and rest per medical personal.
32 2021-01-22 hives Hives developed around mouth and face - symptoms started approximately 1 hour after dose administrat... Read more
Hives developed around mouth and face - symptoms started approximately 1 hour after dose administration; Denies SOB. Wanted a benadryl 25mg given at 2004. Discharged at 2007.
32 2021-01-22 itchy skin, rash Rash began on right elbow around 7 p.m. Slightly, itchy. Then noticed new rash around 10 p.m. On my... Read more
Rash began on right elbow around 7 p.m. Slightly, itchy. Then noticed new rash around 10 p.m. On my right shoulder then within minutes on my left shoulder and at the same time also on both of my cheeks and both cheek rash gradually enlarged. Then noticed more mild generalized rash across back and very slightly on abdomen. Slightly itchy. Tmperature 97 Fahrenheit. Took Zyrtec 10mg. The next day when I woke up at 10 a.m. there was new rash on my ankles and tops of my feet and when I walked there some pain and almost swelling feeling at the bottom of both of my heels and some tightness in my fingers knees ankles and feet when I would bend them, otherwise felt fine. Currently about 3:15 p.m. on 1/ 23 and I still have the rash on my feet and ankles, and slightly on cheeks. 97.7 F temp.
32 2021-01-23 rash Fever, body aches, headache, fatigue, rash after second dose
32 2021-01-24 rash 11:15am - shortness of breath, rash on face and neck, HR 148, BP150/100 - EMS called 11:16am - incre... Read more
11:15am - shortness of breath, rash on face and neck, HR 148, BP150/100 - EMS called 11:16am - increasing shortness of breath, rash on face and neck - Epinephrine EpiPen dose 1 given IM (Lot: 9GM432 Exp: 2/2021 11:17am - HR 152, BP, 170/82, O2sat 100% on room air 11:18am - HR 152, BP 180/90, O2sat 100% on Room air 11:22am - BP 170/98. Rash improving 11:26am - EMS transport arrived. patient walked to ambulance with 2 assist. Patient transported
32 2021-01-24 cellulitis CELLULITIS TREATED WITH KEFLEX
32 2021-01-24 injection site pain I received my second dose at 1:30pm and began having symptoms almost exactly 12 hours later at 1AM t... Read more
I received my second dose at 1:30pm and began having symptoms almost exactly 12 hours later at 1AM the next morning. Symptoms consisted of: fatigue, body aches, chills, fever 101f, headache, and left arm soreness. Symptoms resolved by 8pm that same evening. I did take 1,000 mg tylenol the morning of 1/12 because I had to work, this did help some, but only aided in resolving the headache. 1/11/21: received dose 2 of vaccine at 1:30pm 1/12/21: symptoms began 1AM 1/12/21 symptoms resolved around 8PM
32 2021-01-24 injection site pain Pfizer BioNTech COVID-19 Vaccine EUA 1/11/21: received dose #2 at 1:30PM 1/11/21: 8pm very fatigued... Read more
Pfizer BioNTech COVID-19 Vaccine EUA 1/11/21: received dose #2 at 1:30PM 1/11/21: 8pm very fatigued 1/12/21: 1:00AM chills, body aches, fever 101f, headache, left arm soreness 1/12/21: 8pm symptoms resolved Took tylenol at 8am on 1/12/21 which helped some with the headache
32 2021-01-24 rash, itchy skin Rashes and itching of the skin by breast, stomach, arms and hands. Headaches, chills, Body aches and... Read more
Rashes and itching of the skin by breast, stomach, arms and hands. Headaches, chills, Body aches and fatigue.
32 2021-01-24 injection site redness, injection site swelling, injection site pruritus, injection site pain Redness, swelling, pain, and itching at the injection site Headache Muscle and joint pain Congestion... Read more
Redness, swelling, pain, and itching at the injection site Headache Muscle and joint pain Congestion Fatigue
32 2021-01-24 itchy skin itching at left arm only after 4.5 hrs receiving the vaccine; Benadryl 25mg IM inj given. Symptom re... Read more
itching at left arm only after 4.5 hrs receiving the vaccine; Benadryl 25mg IM inj given. Symptom resolved a few min after getting the Benadryl
32 2021-01-25 itchy skin, vaccination site warmth Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe... Read more
Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe chills with shaking; severe chills with shaking; 103 fever/ approx 20hrs after injection, fever of 100 or greater for 24hrs with minimal relief with Tylenol; body aches; pains in left flank; the first dose on 20Dec2020/second dose on 12Jan2021; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 32-year-old female patient (not pregnant) received the second dose of bnt162b2 via an unspecified route of administration on 12Jan2021 10:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included cardiogenic syncope, no COVID prior vaccination. Concomitant medications included birth control drugs, no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 on 20Dec2020 03:00PM on Left arm for COVID-19 immunization, topiramate (TOPAMAX) and experienced drug allergy, morphine and experienced drug allergy (hives). The patient experienced arm swelling with itchiness and warm to touch at site of injection, severe chills with shaking, 103 fever, approx. 20 hours after injection, fever of 100 or greater for 24 hours with minimal relief with Tylenol, body aches and pains in left flank. The adverse events started from 12Jan2021, 06:00 PM. Therapeutic measures taken for fever included Tylenol, no treatment was received for other events. The outcome of the events was recovering. The patient didn't test COVID post vaccination. Information on the lot/batch number has been requested.
32 2021-01-25 hives Hives on arms, neck, face and abdomen starting at 3pm on 1/26/21. No notable new inciting agents su... Read more
Hives on arms, neck, face and abdomen starting at 3pm on 1/26/21. No notable new inciting agents such as new medications, foods, soaps/detergents/lotions, or chemical exposures.
32 2021-01-25 injection site rash, rash macular Noticed red blotchy rash around injection site 3cm in diameter at 1315. Gave Benadryl 25mg PO. Her t... Read more
Noticed red blotchy rash around injection site 3cm in diameter at 1315. Gave Benadryl 25mg PO. Her throat was feeling a little swollen without difficulty swallowing or breathing. She reports similar reactions to bee stings. No reaction to first dose. At 1325, the rash was almost gone, her throat was feeling better, and she ambulated independently to her vehicle.
32 2021-01-25 rash macular, redness, skin warm Redness of face, cheek, ears (red hot), Upper chest/neck and back was red and blotchy Took Benadryl ... Read more
Redness of face, cheek, ears (red hot), Upper chest/neck and back was red and blotchy Took Benadryl at 8pm and then 4hr later took a second dose with resolution of symptoms States her eczema on hands which continues to increase a week later when this was in remission for a long time
32 2021-01-25 hives, itchy skin full body hives with severe itching; full body hives with severe itching; This is a spontaneous repo... Read more
full body hives with severe itching; full body hives with severe itching; This is a spontaneous report from a contactable physician (reported for herself). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 10Jan2021 11:30 at single dose for Covid-19 immunization. The patient's medical history reported as none; no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced full body hives with severe itching on 11Jan2021 (16:00). The patient received Loratadine and Benadryl as treatment for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
32 2021-01-27 redness PATIENT RECIEVED SECOND COVID 19 VACCINE. PATIENT TOLERATED VACCINE WELL, STAYED IN CLINIC FOR 30 MI... Read more
PATIENT RECIEVED SECOND COVID 19 VACCINE. PATIENT TOLERATED VACCINE WELL, STAYED IN CLINIC FOR 30 MINUTES AT WHICH TIME PATIENT LEFT FACILITY. PATIENT RETURNED STATING AS SOON AS REACHED CAR DEVELOPED FLUSHING/REDNESS IN CHEEKS. 50MG PO BENADRYL WAS ADMINISTERED AND PATIENT WAS MONITORED FRO 1 HOUR. SYMPTOMS DID NOT WORSEN OR NEW SYMPTOMS OCCUR. PATIENT WAS DISCHARGED AT THAT POINT.
32 2021-01-27 injection site pain Pt had injection site tenderness for ~24 hours and night sweats the first night. ~48 hours after inj... Read more
Pt had injection site tenderness for ~24 hours and night sweats the first night. ~48 hours after injection, she developed a "cold" feeling in her calves that over several days had spread to anterior thighs, plus subjective weakness. When I saw her in clinic on 1/27 (day 3 of symptoms), she had no other symptoms. On exam, she had full 5/5 strength and 2+ DTRs (Babinski could not be elicited). She was referred to Neurology who saw her via telemed on 1/28 and agreed on observation unless and until she develops objective weakness.
32 2021-01-27 injection site pain, injection site warmth, injection site redness, injection site mass When I woke up on 1/26/21 my arm was very sore and the injection site was red, painful to touch, hot... Read more
When I woke up on 1/26/21 my arm was very sore and the injection site was red, painful to touch, hot to the touch, and there was a firm lump about an inch and a half in diameter beneath the site. I also did not feel well- with a headache, fatigue, and was very overheated/sweaty. When I woke up on 1/27/21 I felt much better, but the symptoms around the injection site remained the same. Today, 1/28/21, the redness has increased in size, the lump has increased in size, however it is not as firm to the touch. I was prescribed antibiotics by my PCP.
32 2021-01-28 injection site pain, injection site rash Immediate hematoma at injection site, normal injection soreness, no itching, no redness. 10 minutes ... Read more
Immediate hematoma at injection site, normal injection soreness, no itching, no redness. 10 minutes later felt dizziness and light headedness but it only lasted 5 minutes. 20 minutes later pt still has a small bleb at injection site.
32 2021-01-28 itchy skin Itchiness on chest area and lips. Benadryl was provided Itchiness went away. Was held 30 minutes aft... Read more
Itchiness on chest area and lips. Benadryl was provided Itchiness went away. Was held 30 minutes after Benadryl was provided
32 2021-01-28 itchy skin Severe generalized pruritus, likely delayed hypersensitivity; Severe generalized pruritus, likely de... Read more
Severe generalized pruritus, likely delayed hypersensitivity; Severe generalized pruritus, likely delayed hypersensitivity; This is a spontaneous report from a contactable physician (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 10Jan2021 at 08:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included seasonal allergies. Patient has no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021, the patient experienced severe generalized pruritus, likely delayed hypersensitivity. Patient was given antihistamines and topical agents for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information about lot/batch number has been requested.
32 2021-01-28 hives severe cough; left nostril swelling; generalized hives throughout abdomen and hips; lower lip swolle... Read more
severe cough; left nostril swelling; generalized hives throughout abdomen and hips; lower lip swollen/upper lip on left side swelling; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 07Jan2021 at 13:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included allergies to dust, pollen, and dog and cat dander. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on 17Dec2020 at 13:00 on the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021 at 21:00 (five days after second vaccine dose, for clarification), the patient had lower lip swollen. Second episode occurred (on an unspecified date) with severe cough, upper lip on left side swelling, left nostril swelling, and generalized hives throughout abdomen and hips. The patient took Benadryl for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
32 2021-01-29 rash Flushed face and feeling around 30 minutes after injection, 45 minutes wide spread rash over arms, l... Read more
Flushed face and feeling around 30 minutes after injection, 45 minutes wide spread rash over arms, legs and face; tightness in jaw, tongue and face swelling with numbness and tingling.
32 2021-01-29 rash macular Patient came in for COVID vaccine she was in good spirits. After her vaccine, she started off with a... Read more
Patient came in for COVID vaccine she was in good spirits. After her vaccine, she started off with a small cough that started to increase. She started to cough more at which time I requested my RN to come and evaluate her and Monitor her while I reached out to our ER which is attached. We moved the patient to the sleep lab while waiting for the ER to come up. Patient started complaining she felt that her throat was closing. Her O2 was stable at 98/99. Her HR was over 100 bpm. When the ER team came up and put her in a wheel chair her upper lip was swelling and her arm was blotchy. Patient did come up a few hours later to schedule her 2nd dose vaccine after she received a high dose IV Benadryl and Pepcid. She is going to speak to her PCP about this reaction and let me us know if she can take the 2nd dose.
32 2021-01-29 itchy skin Pt developed tingling around mouth and cheeks as well as itching in on the right Shin. Treatment: C... Read more
Pt developed tingling around mouth and cheeks as well as itching in on the right Shin. Treatment: Cetirizine 10 mg PO and an addition 30 minute observation. The pt felt better after the additional wait time, vitals signs stable She was released home.
32 2021-01-30 injection site pain From moments after injection, dizziness and nausea, lack of focus, tingling sensation throughout bod... Read more
From moments after injection, dizziness and nausea, lack of focus, tingling sensation throughout body, injection site pain and body aches, vivid dreams, elevated heart rate during sleep (150bpm), difficulty pronouncing some words, unaware of date and time, fatigue. Nausea, lack of focus, dizziness and tingling sensation improving, but still happening at the time of this report.
32 2021-01-30 injection site swelling, injection site redness, injection site pain I had my vaccine at 10:55am on Saturday. I felt completely fine the rest of the day. Early Sunday ... Read more
I had my vaccine at 10:55am on Saturday. I felt completely fine the rest of the day. Early Sunday morning, around 4am, I woke up sweating and with a fever. My normal temp is around 97.5. My temp was 100.5. For the next 30 hours, I had a fever that ultimately peaked around 101.5 on Sunday evening. I felt very bad, like I had the flu. It is probably the worst I have felt in several years. I had significant muscle pain and even laying on the couch was too uncomfortable. I laid in bed and slept off and on. Monday, when I first woke for work at 5:35am I was still feverish and achy, although I could tell I was better than I had been at my worst Sunday evening. After going back to sleep, I woke up at 10am feeling significantly better. Aside from being rather flushed and sweaty, I felt fine the rest of the day. My injection site was mottled red, swollen, and painful for about three more days, with improvement every day. I am not concerned about my reaction. I am only reporting it to provide data.
32 2021-01-30 injection site pain, injection site swelling My left hand turned blue and the veins in that hand looked very dark (almost purple) seconds after I... Read more
My left hand turned blue and the veins in that hand looked very dark (almost purple) seconds after I received the Pfizer-BioNTech vaccine for COVID-19 in my left arm. My left hand turned blue like it was cold, but I was not cold anywhere on my body. My left hand's veins were also mostly purple in the fingertips. This side effect was not painful and lasted about 30 minutes. Other symptoms I've experienced because of the Pfizer-BioNTech vaccine for COVID-19 in my left arm: - soreness across entire arm, especially at injection site - occurred upon injection and is slowly getting better. I took two 200mg of ibuprofen two days after the injection because the pain randomly got worse without any outward cause - swollen injection site - occurred upon injection and is the same at this time - tingling across entire arm - occurred upon injection and stopped seven hours later at 11pm
32 2021-01-31 hives , . No symptoms at the time of the vaccine had hives overnight several days later no prior history o... Read more
, . No symptoms at the time of the vaccine had hives overnight several days later no prior history of hives or food or drug allergies. Patient went to the ED was treated and released. Symptoms have not recurred
32 2021-01-31 itchy skin, rash I had a full arm rash and all over itching including some in my throat shortly after taking the vacc... Read more
I had a full arm rash and all over itching including some in my throat shortly after taking the vaccine. We knew I was allergic so I had taken medication in advance. Once rash started, two medications were taken- Vistaril and Zyrtec. This seemed to help it go away some though I am still experiencing it. I have alpha gal and I believe that is what made me have a reaction to the vaccine.
32 2021-01-31 injection site pain Moderate Fatigue, extreme muscle soreness and loss of range of motion, pain at injection sight, mild... Read more
Moderate Fatigue, extreme muscle soreness and loss of range of motion, pain at injection sight, mild headache
32 2021-01-31 rash Pt developed a rash all over body, mild SOB, and mild chest tightness approximately 20 minutes after... Read more
Pt developed a rash all over body, mild SOB, and mild chest tightness approximately 20 minutes after receiving the 1st dose of COVID vaccine. Her SpO2= 95% on RA, HR= 105, BP= 111/62. She was given 25mg of IM Benadryl by (RN); code blue called, and team evaluated patient and sent pt. to ER; pt. remained conscious throughout.
32 2021-01-31 rash, rash with redness, rash papular Red raised rash on left side of stomach - no itching. I noticed it while changing 2 1/2 days after g... Read more
Red raised rash on left side of stomach - no itching. I noticed it while changing 2 1/2 days after getting the vaccine
32 2021-01-31 rash, skin spots Started with fever, chills, lethargy, headache and nausea around 0900 on 1/28/21. By 1500 I had seve... Read more
Started with fever, chills, lethargy, headache and nausea around 0900 on 1/28/21. By 1500 I had severe nausea which resulted in vomiting (water and dry heaving) with a small amount of blood (small clots) with first time vomiting. Then at 1700 I could barely move with severe body aches and headache. Attempted to drink some water and eat soup, but intestines burned too much. Slept from 0800 on 1/28/21 through till 0830 on 1/29/21 with very minimal waking. Only left my bed to throw up one time and use the restroom one time. Took Tylenol around the clock. Upon waking on 1/29/21 noticed a petechiae type rash on both sides of my face, sore throat and mild headache (took tylenol). 1/30/21 no symptoms and facial rash slowly disappearing.
32 2021-01-31 rash macular, redness, vaccination site swelling, vaccination site redness, vaccination site warmth, itchy skin, skin discolouration pruritic, textured rash with redness and warmth on the face bilaterally; textured rash with redness ... Read more
pruritic, textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally/cheeks/chin, forehead, ears, nose. Neck and chest spared/unilateral rash (left side)/Rash was red, splotchy in appearance, and flat; textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally; deeper, maroon discoloration; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route at right arm on 16Dec2020 08:15 AM at single dose for COVID-19 immunization. Medical history included depression, ADHD and known allergies: wasp venom (local swelling and redness). Concomitant drugs included methylphenidate hydrochloride (CONCERTA XL), bupropion hydrochloride (WELLBUTRIN XL), escitalopram oxalate (LEXAPRO), and unspecified multivitamin. No other vaccine in four weeks. Historical vaccine included measles vaccine; mumps vaccine; rubella vaccine (MMR VACCIN) for immunization (allergies: local swelling and redness). Patient was not pregnant. No Covid prior vaccination. On 19Dec2020, patient experienced pruritic, textured rash with redness and warmth on the face bilaterally. Most noticeable on cheeks which at times have had deeper, maroon discoloration. Rash also presented on chin, forehead, ears, and nose. Neck and chest spared. Rash recurred daily. It worsened after a warm shower. Additionally, a unilateral rash (left side) was observed for a few minutes on torso and leg after a warm shower 3 days after vaccine. Rash was red, splotchy in appearance, and flat, resolved within minutes (as reported). Right torso and leg were unaffected. No known changes in skin care routine, regular medication or supplements, exposures, chemicals, or contact. No prior history of rashes described. The local injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising. It was reported events resulted in doctor or other healthcare professional office/clinic visit. Treatments Pepcid, ibuprofen (steroid script was not filled) were received for events. Patient had nasal swab/ nasopharyngeal PCR of covid test on 17Dec2020: negative and on 21Dec2020: negative. Outcome of events was not recovered. Information on the lot/batch number has been requested.
32 2021-02-01 hives Itchy hives; This is a spontaneous report from a contactable other health professional (Child life s... Read more
Itchy hives; This is a spontaneous report from a contactable other health professional (Child life specialist) reporting for herself. A 32-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history included depression. Concomitant medication included fluoxetine for anti depressant. Patient stated, "I am here to report side effect with the vaccine (Later clarified as Covid Vaccine Pfizer). 48 hours after getting the vaccine, itchy hives (on 16Jan2021)." Treatment received for the event included Cortisone and Benadryl. The outcome of the event was unknown. Causality reporter stated, "Yes."
32 2021-02-01 vaccination site pain Minor left arm pain at injection site for 24h; malaise for 24h; Left supraclavicular lymphadenopathy... Read more
Minor left arm pain at injection site for 24h; malaise for 24h; Left supraclavicular lymphadenopathy (multiple swollen nodes); This is a spontaneous report from a contactable physician reporting for herself. A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EL3246), via an unspecified route of administration on 08Jan2021 at 11:45 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included drospirenone, ethinylestradiol (OCELLA) taken for birth control from an unspecified date and unspecified if ongoing (reported as taken in two weeks). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took acetylsalicylic acid (ASPIRIN) from an unspecified date to an unspecified date for an unspecified indication and experienced allergy. On 15Jan2021 at 12:00, the patient experienced "minor left arm pain at injection site for 24h", "malaise for 24h" and "left supraclavicular lymphadenopathy (multiple swollen nodes)". The clinical course was reported as follows: "Minor: left arm pain at injection site for 24h and malaise for 24h, left supraclavicular lymphadenopathy (multiple swollen nodes) noticed 7 days after vaccination and still present 11 days after vaccination." It was unknown whether the patient received treatment for the events. The clinical outcomes of the events "minor left arm pain at injection site for 24h", "malaise for 24h" and "left supraclavicular lymphadenopathy (multiple swollen nodes)" were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
32 2021-02-01 redness, itchy skin Pt developed itching across chest, left leg, and back approximately 10 minutes after vaccine adminis... Read more
Pt developed itching across chest, left leg, and back approximately 10 minutes after vaccine administered. She also had mild redness noted across her upper chest and lower back. Patient was given Benadryl 25mg PO liquid upon onset. Vitals 110/80, HR 63, O2 sat 99. 15 minutes post Benadryl, patient reports itching is improving as is redness. She was observed for 45 minutes after Benadryl was administer. Vitals remained unchanged. Patient reported no more itching/redness and was sent home via driver.
32 2021-02-01 itchy skin, injection site pain Pt. C/O pain at the site of injection as well as itchiness at the back of her left arm. No erythema ... Read more
Pt. C/O pain at the site of injection as well as itchiness at the back of her left arm. No erythema was seen, no edema, no appearance of hives. Pt. stated she had severe pain in her arm after the first vaccine as well as fever to 101F but that symptoms subsided over the following 48 hours.
32 2021-02-01 shingles Shingles behind left ear the morning after (31Dec2020)Vaccine received; This is a spontaneous report... Read more
Shingles behind left ear the morning after (31Dec2020)Vaccine received; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El1284), via an unspecified route of administration on 30Dec2020 16:30, at left arm, at single dose for covid-19 immunization. Medical history included atopic dermatitis (eczema). No known allergies. Concomitant medication included melatonin. The patient experienced shingles behind left ear the morning after (31dec2020) vaccine received on 31Dec2020 09:00. Event resulted in Emergency room. The patient underwent lab tests and procedures which included covid test Nasal Swab (Fulgent Genetics) post vaccination: negative on 08Jan2021. Therapeutic measures were taken as a result of shingles behind left ear the morning after (31Dec2020) includes oral Antibiotics, oral Antivirals, antibiotic shot. The outcome of the event was recovered on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based solely on a chronological association, a causal relationship between event "patient experienced shingles behind left ear the morning after vaccination" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
32 2021-02-01 itchy skin, rash Vaccine Center documentation record notes patient had Pfizer vaccination. Pt did have a running nose... Read more
Vaccine Center documentation record notes patient had Pfizer vaccination. Pt did have a running nose the day she received the second vaccination. She has a rash all over her body with severe itching. She wants a referral to see an Immunologist.
32 2021-02-02 itchy skin Crawling out of my skin itchy. Thought it might just be dry skin so I have used lotion, coconut oil ... Read more
Crawling out of my skin itchy. Thought it might just be dry skin so I have used lotion, coconut oil and baby oil. My skin has never been so soft but I?m still so itchy. Legs, arms, feet, hands -entire body. Itchiness is pretty much constant
32 2021-02-02 pain of skin Within 18 hours of the vaccine, I experienced: arm pain, fever, sore joints, skin hurt to the touch,... Read more
Within 18 hours of the vaccine, I experienced: arm pain, fever, sore joints, skin hurt to the touch, UTI sensation when urinating Within 2 days, I experienced: sore joints, skin hurt to the touch, UTI sensation when urinating, sore throat Within 3 days, I experienced: skin hurt to the touch, UTI sensation when urinating, sore throat, sores inside of mouth Within 4 days, I experience nausea and still had sores in my mouth
32 2021-02-02 redness, rash macular Within five minutes of injection mild headache. Within seven minutes of injection lightheadedness de... Read more
Within five minutes of injection mild headache. Within seven minutes of injection lightheadedness developed. At eight minutes severe burning within chest. This initial onset symptoms did resolve within five minutes, however recurred times for over the course of 20 minutes.. After 30 minutes post injection, right forearm and lower left abdomen with blotchy erythema. Throughout the rest of the day roof of mouth and throat mildly pruritic. Overnight severe diaphoresis. Following day mild Tonsillar lymphadenopathy, hoarseness of voice, sore throat, chest tightness.
32 2021-02-03 vaccination site pain Fever; chills; nausea; body aches; headache; sore arm where injection was done; This is a spontaneou... Read more
Fever; chills; nausea; body aches; headache; sore arm where injection was done; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249), intramuscular on 21Jan2021 11:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at vaccination was 32 years. The patient was vaccinated at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 9231) intramuscular on 31Dec2020 06:30 PM, at single dose in left arm. The patient has no allergies to medications, food, or other products and had no relevant medical history. Concomitant medications included celecoxib (CELEXA), zonisamide (ZONEGRAN), loperamide hydrochloride (MEDIUM). On 21Jan2021 at 03:00 AM (as reported pending clarification) the patient experienced fever, chills, nausea, body aches, headache, sore arm where injection was done. The events were reported as non serious. No treatment was received for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
32 2021-02-03 itchy skin, skin swelling, redness, hives I developed hives on 1/23/21 and currently still have them. Itchy skin over my entire body from the ... Read more
I developed hives on 1/23/21 and currently still have them. Itchy skin over my entire body from the bottom of my feet, to my toes, palms, eyelids, etc. Skin turns red and raised. Initially I took 2 pills of Benadryl every couple of hours, but the symptoms only lessened slightly and were still there. I went to Urgent Care, on 1/28/21 and was prescribed 50mg prednisone daily, which I took for 5 days (as prescribed). Symptoms continued and did not lessen. I went to Allergist 2/3/21, who prescribed an antihistamine and reported to follow up in a couple of days if symptoms are still present.
32 2021-02-03 injection site pain Mild flu like symptoms started 1/5: low grade fever of 99.3-100.5, sore arm at injection site, body ... Read more
Mild flu like symptoms started 1/5: low grade fever of 99.3-100.5, sore arm at injection site, body aches, fatigued. 1/6: Fever and body aches gone. Hot flashes/sweating for half the day and tired. 1/7: all better, no more symptoms.
32 2021-02-03 injection site pain Pain at injection site beginning immediately after receiving the vaccine.. Headache, fatigue, body ... Read more
Pain at injection site beginning immediately after receiving the vaccine.. Headache, fatigue, body aches, chills beginning overnight. Took OTC Motrin at 7PM with improvement of symptoms. Symptoms currently still occurring.
32 2021-02-03 rash, rash with redness Patient got her Covid-19 vaccine around 8:00 AM on 1/19/21. Around 10:00 AM patient presented at u... Read more
Patient got her Covid-19 vaccine around 8:00 AM on 1/19/21. Around 10:00 AM patient presented at urgent care clinic. Reported red spots on her neck, face and chest. Patient also have throat discomfort, feels like she needs an extra effort to breath. Benadryl 25 mg po given per MD order.
32 2021-02-03 skin infection at injection site cellulitis in right arm below injection site; fever; headache; chills; fatigue; This is a spontaneou... Read more
cellulitis in right arm below injection site; fever; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 11Jan2021 at 07:45 AM at a single dose for COVID-19 immunization in a hospital. Medical history reported as none. The patient has no known allergies. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 23Dec2020 at 07:45 AM in left arm for COVID-19 immunization. Concomitant medications included dicyclomine; and unspecified birth control and multivitamin. The patient experienced fever, headache, chills, fatigue, and then got cellulitis in right arm below injection site following second dose of COVID vaccine on 14Jan2021 at 12:00 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received antibiotics (Keflex) as treatment for the events. The patient recovered from the events in Jan2021. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Vaccination site cellulitis cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
32 2021-02-04 rash, itchy skin Patient developed generalized itching and mild rash.
32 2021-02-04 vaccination site itchiness, vaccination site hardening, vaccination site swelling, vaccination site redness, vaccination site warmth Silver dollar sized swelling and redness around the injection site for 4 days; Silver dollar sized s... Read more
Silver dollar sized swelling and redness around the injection site for 4 days; Silver dollar sized swelling and redness around the injection site for 4 days; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching; This is a spontaneous report from a contactable Other Health Professional (patient). A 32-years-old female patient received first dose bnt162b2 (BNT162B2, lot: EL3247), intramuscular on 14Jan2021 11:15 at SINGLE DOSE on Arm Left for covid-19 immunisation. The patient medical history was not reported. Pregnant: No. No other vaccine in four weeks. The patient's concomitant medications were none. The patient experienced Adverse event: Silver dollar sized swelling and redness around the injection site for 4 days. After 4 days the redness subsided but a knot remains under the skins surface with heat to the touch and itching since 18Jan2021. The event outcome of redness around the injection site was recovered on 22Jan2021, outcome of other events were not recovered. No treatment received.
32 2021-02-04 hives, redness hands turned red and swollen, then quickly progressed to red face/cheeks, hives on chest and arms wi... Read more
hands turned red and swollen, then quickly progressed to red face/cheeks, hives on chest and arms within 10 minutes, evaluated by EMS, 50mg Benadryl given po, epi given IM by EMS also, transported by ambulance to ED
32 2021-02-05 rash Flu like symptoms: chills, headache, body aches (all within 12 hours, most symptoms decreased after ... Read more
Flu like symptoms: chills, headache, body aches (all within 12 hours, most symptoms decreased after 24 hours but still lingered for 2 days) Rash on arm where shot was given - 2 days after injection
32 2021-02-05 hives Hives
32 2021-02-06 hives Small hives in strange parts of the body (opposite arm from shot, belly, inner thigh. Not a rash-- j... Read more
Small hives in strange parts of the body (opposite arm from shot, belly, inner thigh. Not a rash-- just isolated hives, about five in total. the The specific hives, in a quantity as large as 5 in disparate areas, is unusual for me
32 2021-02-07 injection site pain 1st Pregnancy - estimated due date of 06/29/2021 Vaccine side effects: . Sore at injection site - 12... Read more
1st Pregnancy - estimated due date of 06/29/2021 Vaccine side effects: . Sore at injection site - 12 hours after receiving vaccine - lasted for 48 hours. Fatigue - 2 hours after receiving vaccine - lasted for 12 hours. Headache - 12 hours after receiving vaccine - lasted for 12 hours. No medical treatment necessary.
32 2021-02-07 redness About 30 minutes after the shot, my face became very red and flushed. I continued driving home and t... Read more
About 30 minutes after the shot, my face became very red and flushed. I continued driving home and took xyzal when I arrived. My face cleared up about an hour later. My left arm has been sore since the shot (3 days now). Also the next day after my shot, I was completely exhausted.
32 2021-02-07 vaccination site redness, vaccination site itchiness Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she ... Read more
Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Reaction was her arm was itchy and inflamed and red on the inside of her elbow on the arm where she received the shot; Pimple-like rash; Anxiety; Felt a little odd; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma from 1993 to an unspecified date (diagnosed when she was 5). Concomitant medication included tetanus vaccine (Lot number: U6830A; Expiration date: 17Sep2022) on 06Jan2021. On 20Jan2021 (15:00), the patient had reaction on her arm that was itchy, inflamed and red on the inside of her elbow on the arm where she received the vaccination shot. In Jan2021, the patient had pimple-like rash; anxiety; and had felt a little odd. The patient had received diphenhydramine (BENADRYL) as treatment for the events, 'reaction on her arm that was itchy, inflamed and red on the inside of her elbow on the arm where she received the vaccination shot' and 'pimple-like rash'. The outcome of the events was unknown.
32 2021-02-07 injection site redness, injection site warmth, injection site hardening, injection site swelling Severe muscle soreness across full body that is still ongoing 24 hours later Extreme tiredness that ... Read more
Severe muscle soreness across full body that is still ongoing 24 hours later Extreme tiredness that lasted the full day Headache/feelings of dehydration Low grade fever Site of injection is still (two days later) red, raised, warm, and slightly firm to the touch I treated with tylonel and took my medication for surgical recovery (cyclobenzaprine and hydrocodone two hours after shot, Valium overnight, and cyclobenzaprine once the day after my shot)
32 2021-02-07 itchy skin pt experienced severe itching around her face and on the vaccinated arm, the itching became worse ov... Read more
pt experienced severe itching around her face and on the vaccinated arm, the itching became worse over ten minutes and progressed to the inside of her mouth around her lips, she was given 25mg of benedryl and the itching resolved within 45 minutes.
32 2021-02-08 hives Developed hives over body within 3 hours of initial vaccine. Hives have been intermittent, site of v... Read more
Developed hives over body within 3 hours of initial vaccine. Hives have been intermittent, site of vaccine is not affected. Also has increase in heart burn symptoms including nausea with vomiting and upper abdominal pain. At home, has been trying Tylenol, OTC benadryl, OTC allergra, and pepcid. In clinic, given zofran follow by viscous lidocaine with AlMgH. Prescribed prednisone taper for home. Prescribed zofran for home for nausea.
32 2021-02-09 injection site mass, redness Migraine, redness, pain, and large lump at injection site, runny nose, fatigue
32 2021-02-09 vaccination site pain, vaccination site swelling Pain at injection site; swelling at injection site; fever; chills; body aches; muscle pain; nausea; ... Read more
Pain at injection site; swelling at injection site; fever; chills; body aches; muscle pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm, on 23Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history was unknown. Patient is not pregnant. Patient did not have COVID prior vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included Ibuprofen and Acetaminophen. Patient previously received first dose of BNT162B2 (Lot number: EK9231) via an unspecified route of administration in the left arm on 02Jan2021 11:15 at the age of 32 years for COVID-19 immunisation. Patient experienced pain at injection site, swelling at injection site, fever, chills, body aches, muscle pain, nausea on 24Jan2021 03:00. The patient did not receive treatment for the events. Patient tested COVID post vaccination through nasal swab which revealed negative on 08Jan2021. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
32 2021-02-09 injection site pruritus, injection site swelling, injection site warmth, injection site redness, injection site hardening, injection site pain Swelling and hardness at injection site, redness, warm to touch, itching, soreness. Redness speading... Read more
Swelling and hardness at injection site, redness, warm to touch, itching, soreness. Redness speading still on going 5 days after dose was received and itching still on going. The swelling and firmness is reduced.
32 2021-02-09 rash, itchy skin rash and itching on legs, light headed, difficulty breathing, nausea and abdominal cramping. given E... Read more
rash and itching on legs, light headed, difficulty breathing, nausea and abdominal cramping. given EPI pen in clinic and transported to hospital ER by EMS. given solumedrol, Benadryl and Pepcid in the ED. was eventually discharged. continue steroids, Benadryl, and Pepcid.
32 2021-02-09 rash with redness reddish, flat rash on my right abdomen and chest; Dose 1 administration date 05Jan2021, Dose 2 admin... Read more
reddish, flat rash on my right abdomen and chest; Dose 1 administration date 05Jan2021, Dose 2 administration date 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second single dose of BNT162B2 (Solution for injection, lot number: EL9262, exp date not reported), intramuscular (vaccine location: Left arm) on 22Jan2021 16:15 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included asthma, and penicillin allergy. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient previously took first single dose of BNT162B2 (Pfizer, lot number: unknown) intramuscularly (vaccine location: Left arm) on 05Jan2021 for COVID-19 immunization. The patient noticed on 22Jan2021 at 9:00 pm reddish, flat rash on right abdomen and chest. Treatment received for the adverse event included diphenhydramine (BENADRYL) 50 mg. The events went away. Since the vaccination, the patient has not been tested for COVID-19. The events were considered as non-serious by the reporter. The patient recovered from the event on an unspecified date in Jan2021.
32 2021-02-09 rash, itchy skin severe itching and pain; severe itching and pain; developed a rash on my back; stomach felt like fir... Read more
severe itching and pain; severe itching and pain; developed a rash on my back; stomach felt like fire ants were crawling and biting me; stomach felt like fire ants were crawling and biting me; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the left arm on 21Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included diabetes, asthma and known allergies: neutrogena products. Concomitant medication included metformin and ibuprofen (ADVIL [IBUPROFEN]). On 22Jan2021 01:20 am the patient woke up from severe itching and pain. The patient had developed a rash on her back and stomach felt like fire ants were crawling and biting her. The only thing that came to her mind was taking an oral antihistamine so she took diphenhydramine (BENADRYL), the rash and itching was gone in the morning on Friday she had a discussion with the physician she worked with to let him know what had happened, to get his opinion on if she should get the 2nd vaccine. She took another diphenhydramine the Friday night just in case no itching didn't take diphenhydramine on Saturday however the itching returned on Sunday the late afternoon approx at 4pm took another diphenhydramine but still feeling a little itching the back and stomach (no new foods lotions soaps or supplements were started so it had to be the vaccine). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
32 2021-02-09 vaccination site redness, vaccination site rash, rash woke up 1/23/21 with redness at injection site; a rash on the arm of said injection, right arm; a ra... Read more
woke up 1/23/21 with redness at injection site; a rash on the arm of said injection, right arm; a rash on the arm of said injection, right arm; This is a spontaneous report from a contactable healthcare professional who is the patient. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), intramuscularly on 22Jan2021 at 08:45 (at the age of 32-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included AV node re-entrant phenomenon. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246) intramuscularly in the right arm on 31Dec2020 at 8:30 AM. The patient is allergic to morphine and "Celcor." The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ivabradine hydrochloride (CORLANOR) 5 mg half tablet twice daily with food. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient woke up on 23Jan2021 at 08:00 with redness at the injection site and a rash on the arm of said injection site (right arm). The patient did not receive any treatment for the events. The clinical outcomes of the events injection site redness and rash were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
32 2021-02-11 itchy skin, hives Pt received second dose of Pfizer vaccination at 0910. At 0925, pt notified staff of intermittent fe... Read more
Pt received second dose of Pfizer vaccination at 0910. At 0925, pt notified staff of intermittent feelings of shortness of breath and lightheadedness. Pt verbalized she had no intake for the morning was given apple juice and animal crackers. At 1015, pt reported to staff of continuing intermittent feelings of lightheadedness, shortness of breath and itching on the legs. Pt was transported to private area for further assessment via wheelchair and assisted to lie down on massage table. A provider on duty assessed pt at 1015 and administered Epipen at 1020 for potential allergic reaction. Pt reported to have taken Lorazepam (dose unknown) prior to appointment at 0905. Symptoms were discussed with pt and agreed to have EMS transport to ED for further monitoring. EMS was called and they transported pt to WW ED. 0925 Vitals: BP-108/64, P-64, O2-97%, Resp-20 1015 Vitals-BP-104/60, P-78, O2-100%, Resp-20 1035 Vitals-BP-124/68, P-80, O2-100%, Resp-20 Admin: Epinephrine (EPIPEN) 0.3mg/0.3 mL injection R thigh transported to ED next to clinic. ED COURSE & MEDICAL DECISION MAKING: 11:10 AM I met with the patient, obtained history, performed an initial exam, and discussed options and plan for treatment here in the ED. I was wearing PPE including N95 mask and face shield. 11:19 AM Paged allergist. 11:40 AM I discussed the patient with allergist from Fairview. He does not recommend any additional labs or treatment for the patient. 2:12 PM I rechecked on the patient and she is feeling better. We discussed the plan for discharge and the patient is agreeable. Reviewed supportive cares, symptomatic treatment, outpatient follow up, and reasons to return to the Emergency Department. Patient to be discharged by ED RN. Pertinent Labs & Imaging studies reviewed. (See chart for details) 32 y.o. adult presents to the Emergency Department for evaluation of allergic reaction. Had onset of symptoms within a few minutes of receiving her second Pfizer COVID-19 vaccination today. Symptoms seem consistent with allergic reaction including itching, hives, feeling lightheaded, nausea, and some abdominal cramping. She was given an EpiPen prior to arrival and brought here by EMS. There she was also given Benadryl, Solu-Medrol, and Pepcid. Other than some mild itching, did not have any return of other symptoms. Given prescriptions to continue with Claritin, Pepcid and prednisone. Also prescriptions for EpiPen was provided. Did briefly discuss with the allergist on call. No additional recommendations at this time. I do recommend that she follow-up with an allergist sometime the next few weeks. She was advised to return to the emergency department for any new or worsening symptoms or other concerns. At the conclusion of the encounter I discussed the results of all of the tests and the disposition. The questions were answered. The patient or family acknowledged understanding and was agreeable with the care plan. MEDICATIONS GIVEN IN THE EMERGENCY: Medications methylPREDNISolone sod suc(PF) injection 125 mg (Solu-MEDROL) (125 mg Intravenous Given 2/10/21 1135) diphenhydrAMINE injection 25 mg (BENADRYL) (25 mg Intravenous Given 2/10/21 1137) famotidine 20 mg injection (20 mg Intravenous Given 2/10/21 1138) Transported to ED by EMS. Symptoms seem comsistent with allergis reaction including itching, hives, feeling lightheaded, nausea, and some abdominal cramping. Given Benadryl, Solu-Medrol and Pepcid. Other than mild itching, did not have any return of other symptoms. Given prescriptions to continue with Claritin, Pepcid and prednisone. ALso given prescription for EpiPen. Did briefly discuss with allergist on call. No additional recommendations at this time. I do recommend that she follow-up with an allergist sometime the next few weeks. Pt returned to ED later in the evening reporting throat tightness and itching. Normal vitals and no objective signs of anaphylaxis. DC'd to home.
32 2021-02-15 itchy skin, injection site swelling, injection site redness, rash, injection site pain Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection... Read more
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremities)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: tingleness and numbess on left arm-Mild, Additional Details: Patient stated she felt tinglyness, numbness, slight chill, along with a little bit bumps along her left arm where the vaccine was given (L). I monitored the patient for an extra 30 minutes and gave the patient one dose of benadryl. I checked back with her after 30 minutes and she was doing fine and felt good and able to leave.
32 2021-02-18 pain of skin Since last report: Feeling skin tenderness and pain - all over. Not visible Bruising - but feels lik... Read more
Since last report: Feeling skin tenderness and pain - all over. Not visible Bruising - but feels like bruising.
32 2021-02-21 injection site pain Injection site pain, body aches, fatigue
32 2021-02-21 injection site pain Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took... Read more
Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took ibuprofen at onset of symptoms, headache subsided but the rest lingered for another 24 hours.
32 2021-02-22 injection site pain Tenderness on the injection site left arm, Right hip pain, Right elbow pain, Headache and fatigue
32 2021-02-23 vaccination site swelling, vaccination site pain My left hand turned blue and the veins in that hand looked very dark (almost purple); soreness acros... Read more
My left hand turned blue and the veins in that hand looked very dark (almost purple); soreness across entire arm, especially at injection site; swollen injection site; tingling across entire arm; soreness across entire arm; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 27Jan2021 16:00 (lot number: EN5318), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in public health department. The patient's medical history includes sciatic nerve pain, allergic to cats and some dogs, back pain from scoliosis and anemic, all from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient stated her left hand turned blue and the veins in that hand looked very dark (almost purple) seconds after receiving the vaccine in the left arm on 27Jan2021 16:00. Her left hand turned blue like it was cold, but she was not cold anywhere on my body. Her left hand's veins were also mostly purple in the fingertips. The side effect was not painful and lasted about 30 minutes. Other symptoms experienced because of the COVID-19 vaccine in left arm were soreness across entire arm, especially at injection site occurred upon injection and was slowly getting better. The patient took two 200mg of ibuprofen two days (however the patient also reported no treatment was received for the events) after the injection because the pain randomly got worse without any outward cause, swollen injection site occurred upon injection and is the same at this time. Tingling across entire arm occurred upon injection and stopped seven hours later at 11pm. The consumer assessed the events as non-serious. The outcome of the event tingling across entire arm recovered on 27Jan2021 at 11 PM and "my left hand turned blue and the veins in that hand looked very dark (almost purple)" was recovered on 27Jan2021 and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.
32 2021-02-23 vaccination site rash, vaccination site redness Noticed red blotchy rash around injection site 3cm in diameter; Noticed red blotchy rash around inje... Read more
Noticed red blotchy rash around injection site 3cm in diameter; Noticed red blotchy rash around injection site 3cm in diameter; Her throat was feeling a little swollen without difficulty swallowing or breathing; This is a spontaneous report received from a contactable pharmacist (reporting for a patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular in the left arm on 25Jan2021 13:15 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history was unknown. The patient had no known allergies. It was unknown if the patient had COVID prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medication was unknown. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in the left arm on 04Jan2021 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunization; the patient had no reaction to the first dose. On 25Jan2021, the patient noticed a red blotchy rash around injection site 3 cm in diameter at 13:15. She was treated with diphenhydramine hcl (BENADRYL) 25 mg orally one dose. Her throat was feeling a little swollen without difficulty swallowing or breathing (also at 13:15 on 25Jan2021). She reported similar reactions to bee stings. At 13:25, the rash was almost gone, her throat was feeling better, and she ambulated independently to her vehicle. The clinical outcome of the events was recovered on an unspecified date in 2021.
32 2021-02-23 vaccination site pain some very pain/soreness at the injection site; This is a spontaneous report from a non-contactable c... Read more
some very pain/soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient receive the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN 5318, expiry date: 31May2021), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that in the morning on 27Jan2021, the patient experienced some very pain/soreness at the injection site but was less intense than what the experienced with a non-Pfizer influenza shot on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
32 2021-02-24 injection site pain Immediately after getting the vaccine, I noticed a strong metallic taste in my mouth. The metallic t... Read more
Immediately after getting the vaccine, I noticed a strong metallic taste in my mouth. The metallic taste lasted for approximately 5 days, decreasing in strength over time. Within 10-15 minutes of getting the vaccine, parts of my face went partially numb (primarily under my lips and along my right cheek). The numbness was largely improved after 1.5 weeks, but I continue to experience it intermittently 3+ weeks later. I also had severe jaw pain that lasted for about 2 weeks, on and off. Within about an hour of receiving the vaccine, I noticed a small amount of rectal bleeding as well; this resolved within the same day. Beyond that, my symptoms were "normal" -- pain at the injection site, mild nausea and chills on the day of the vaccine. I spoke with 5 different doctors about the facial numbness, and none of them were able to advise me on why that might have happened. My primary care physician recommended against getting the second shot until we have more information about what would cause these side effects.
32 2021-02-24 redness Left became irritates with erythema and had blurred vision which resolved by the following day.
32 2021-02-24 injection site tingling, injection site pain Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
32 2021-02-24 hives, rash with redness Within 2 minutes of vaccine receipt the patient became agitated. She was noted to have erythematous ... Read more
Within 2 minutes of vaccine receipt the patient became agitated. She was noted to have erythematous macules on her upper back consistent with hives. Her heart rate and respiration rates were normal. She was observed initially as the family reported that she gets hives with all injections. However, about 2 minutes later she began to retch and stated that her throat was burning and she couldn't breathe. She was administered 0.3mg of epinephrine via an autoinjector. Her shortness of breath and throat burning symptoms resolved almost immediately. She was then given 10mg of Cetirizine PO and transported via local EMS for evaluation at the Hospital ED.
32 2021-02-25 skin warm, rash with redness, itchy skin "Covid arm" large rash, red, itchy, warm, sore
32 2021-02-25 rash Fatigue; Headache; fever (~100F); joint pain; chills; facial rash (flat, bright red rash on both che... Read more
Fatigue; Headache; fever (~100F); joint pain; chills; facial rash (flat, bright red rash on both cheeks and chin); This is a spontaneous report from a contactable consumer (patient). A 32-years-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL8982), via an unspecified route of administration on 24Jan2021 at 12:15 at single dose in left arm for COVID-19 immunisation. Medical history included depression and anxiety. Concomitant medication included sertraline and buspirone, both from unknown date for unknown indication. The patient experienced fatigue, headache, fever (~100f), joint pain, chills, facial rash (flat, bright red rash on both cheeks and chin), all on 24Jan2021 18:30 with outcome of recovering. No treatment was received. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. This case was reported as non-serious.
32 2021-02-25 rash with redness Gave her an entire vial instead of one dose; Giant red circle/rash; Really swollen; Inflamed; Painfu... Read more
Gave her an entire vial instead of one dose; Giant red circle/rash; Really swollen; Inflamed; Painful; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable consumer (patient) reported that a 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 04Feb2021 (10:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store (not a military facility). The patient did not have relevant medical history. Concomitant medication included ongoing amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient previously took a flu shot a couple of months ago, and had no reaction. On 04Feb2021 (10:00), the pharmacy reportedly screwed up, and gave the patient an entire vial of BNT162B2 instead of one dose. The patient was not feeling any side effects then. In Feb2021, the patient had a giant red circle/rash; and she was really swollen, inflamed and in pain (reported as "painful"). The patient did not receive any treatment for the giant red circle/rash and pain. The outcome of the events was recovering for 'giant red circle/rash', 'really swollen', 'inflamed' and 'pain'; and was unknown for 'gave the patient an entire vial of BNT162B2 instead of one dose'. The reporter had asked about whether she should receive the second dose. Follow-up (08Feb2021): New information received from a contactable consumer (patient) included: reporter information, suspect vaccine details and new events ('giant red circle/rash', 'really swollen', 'inflamed' and 'pain').
32 2021-02-25 itchy skin Left shoulder blade area felt itchy. Symptoms resolved
32 2021-02-25 redness, rash with redness, itchy skin Red swelling of entire arm. Pain over the entire arm. Red rash and swelling on the upper back. Itchi... Read more
Red swelling of entire arm. Pain over the entire arm. Red rash and swelling on the upper back. Itchiness.
32 2021-02-25 injection site pain, hives, itchy skin soreness at injection site, migraine, second day on menstrual cycle - heavy bleeding, extra hungry, ... Read more
soreness at injection site, migraine, second day on menstrual cycle - heavy bleeding, extra hungry, feeling tired, itchiness, hives around neck area
32 2021-02-26 injection site pain, injection site swelling, injection site redness, injection site warmth Swelling. Redness, pain, warmth at injection site
32 2021-02-27 itchy skin I received the shot at about 4:00 pm. Around 6:30 or so I started to get a runny nose, my skin on m... Read more
I received the shot at about 4:00 pm. Around 6:30 or so I started to get a runny nose, my skin on my neck was itching, I was sneezing, and it felt like my eye was starting to swell. I took a Claritin around 6:45. My allergy symptoms started to subside and then completely went away.
32 2021-02-28 vaccination site pain Pain at injection site; This is a spontaneous report from a contactable consumer (patient herself). ... Read more
Pain at injection site; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 26Jan2021 at 11:45 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included ibuprofen (ADVIL), paracetamol (TYLENOL), and multivitamins (unspecified); also reported as medications that the patient received within two weeks of vaccination. The patient previously took amoxicillin and Cefzil and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient experienced pain at injection site on 27Jan2021. The patient has not tested positive for COVID-19 since the vaccination. The patient did not receive any treatment for the event. Outcome of the event was recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
32 2021-02-28 itchy skin Pt c/o "itchiness" on her arms, legs and abdomen. EMS present and attended to pt.
32 2021-03-01 injection site redness Throbbing pain, swelling, and redness at injection site Headache Fatigue Muscle Aches Chills
32 2021-03-02 injection site redness, injection site pruritus, injection site discomfort, injection site swelling Redness, swelling, itchiness, and sensitivity around injection site, roughly 2 inches in diameter. D... Read more
Redness, swelling, itchiness, and sensitivity around injection site, roughly 2 inches in diameter. Developed around 20 hours after injection.
32 2021-03-03 rash Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify:... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Mild, Additional Details: PATIENT REPORT ITCHING IN HER THROAT AREA WITH A LITTLE TIGHTNESS AFTER COVID VACCINE, SO GAVE HER BENADRYL. A FEW MINUTES AFTER THAT, SHE WAS A LITTLE SHAKY AND DIZZY. EMS WAS CALLED, AND TENDED TO HER IN THE PHARMACY AREA. SHE WAS OK AFTER
32 2021-03-03 injection site redness, injection site pruritus, injection site swelling red, itchy around the injection site - slight swelling
32 2021-03-05 hives, itchy skin 2 hrs after vaccine- headache 6 hours after vaccine- terrible headache 8 hours after vaccine- nausea... Read more
2 hrs after vaccine- headache 6 hours after vaccine- terrible headache 8 hours after vaccine- nausea and vomiting 24 hours after vaccine- hives& itching around stomach, legs
32 2021-03-05 redness Fever, muscle pain, fatigue, redness in face, metallic taste in mouth, soreness
32 2021-03-06 hives Near end of 15 minute observation she developed hives on lower neck/upper chest. Some slight throat ... Read more
Near end of 15 minute observation she developed hives on lower neck/upper chest. Some slight throat fullness - no history of shortness of breath, dysphagia. Vital signs obtained by EMS - Benadryl 50mg po given - hives faded some. Watched for additional 20 minutes and sent home. Informed patient she needs clearance from doctor if she wants dose #2.
32 2021-03-07 hives Patient developed hives the next day. Since 2/5/21, they come and go. No reaction s/p first dose
32 2021-03-07 itchy skin Pruritis
32 2021-03-08 injection site redness, injection site hardening Patient reports that she received second Pfizer Covid vaccination "on the back of her arm". This cou... Read more
Patient reports that she received second Pfizer Covid vaccination "on the back of her arm". This could have possibly resulted in inappropriate subcutaneous administration (instead of intramuscular). She experienced local redness and induration, but this was painless.
32 2021-03-08 hives, rash Rash/hives throughout upper body
32 2021-03-08 itchy skin Symptoms: Tightness of chest, fast heart rate, facial and scalp itching Outcomes: Given benadryl at... Read more
Symptoms: Tightness of chest, fast heart rate, facial and scalp itching Outcomes: Given benadryl at 12:30, consulted with MD, 2nd dose given at 12:45. Stable VS throughout. Patient advised to get ride home.
32 2021-03-09 skin peeling Bilateral swollen eye lids and bruising. Started when I woke up the morning after the vaccine. Mildl... Read more
Bilateral swollen eye lids and bruising. Started when I woke up the morning after the vaccine. Mildly itchy, and sore. Swelling went down within 8 hours, bruising went away next day. The following day the skin on my eye lids were very dry, craking/flaking , sore and itching. Applied lotion and resolved on its own.
32 2021-03-09 rash, itchy rash, rash papular, rash with redness, skin warm Hot red itchy raised rash on face around eyes, forehead, ears, cheeks
32 2021-03-09 redness, hives Patient noted erythema and urticaria within 5 minutes after vaccine. Given Zyrtec 10mg and water. Cu... Read more
Patient noted erythema and urticaria within 5 minutes after vaccine. Given Zyrtec 10mg and water. Currently feeling better at this time.
32 2021-03-09 hives, injection site swelling, injection site pruritus Welts with Swelling and itching at the injection 8 hours after receiving injection. Body aches, chil... Read more
Welts with Swelling and itching at the injection 8 hours after receiving injection. Body aches, chills,
32 2021-03-10 sensitive skin Body pain more reminiscent of radiating nerve pain than flu body aches. Its the worst around my sac... Read more
Body pain more reminiscent of radiating nerve pain than flu body aches. Its the worst around my sacrum and radiating down the backs of my legs to the soles of my feet. I also have pain radiating up my spine over the top of my head and down the backs of my arms to my palms. My skin is hypersensitive and everything that touches it feels like sand paper. I started getting chills so bad my hands and feet went numb.
32 2021-03-10 rash papular I developed severe eczema rash on my hands, fluid filled lesions, were draining. I went to urgent c... Read more
I developed severe eczema rash on my hands, fluid filled lesions, were draining. I went to urgent care where they examined me. I had to get treated for these lesions.
32 2021-03-10 skin warm I received the vaccine on Friday, February 26th, 2021, around 10:20am. I was fine throughout the da... Read more
I received the vaccine on Friday, February 26th, 2021, around 10:20am. I was fine throughout the day. I was also fine all day on Saturday, February 27th, 2021. Sunday, February 28th, 2021 at 1:30am, I woke up from sleep with double vision, dizziness, and lightheadedness. I went to use my bathroom, and began to feel week. I was still very lightheaded, and weak. I felt as though I was going to faint. My ears started to feel really warm, and I then vomited. I started feeling lightheaded and weak once again, and then suddenly had diarrhea. I was so dizzy, but managed to head to my bed to sleep. Every single day since, I have been dizzy and losing my balance. I wake up, walk around, and sleep dizzy. Then on Friday, March 5th, 2021 I developed a large lump directly under my armpit. I could not take the dizziness any longer and I went to the ER on Monday, March 8th. I was then diagnosed with vertigo and told that I most likely had lymphodenopathy. Till this day, I am still having dizziness and will be seeing an ENT doctor. I also still have the lump under my armpit. My next dose is, March 19th, 2021.
32 2021-03-10 hives, itchy skin Shortness of breath, itching, dizziness, headache, low blood pressure, hives. These symptoms came on... Read more
Shortness of breath, itching, dizziness, headache, low blood pressure, hives. These symptoms came on right after the vaccine was administered.
32 2021-03-10 skin burning sensation Woke up on Wednesday, 2/24, approx. 12:00am to my entire left arm numb. Woke up and numbness changed... Read more
Woke up on Wednesday, 2/24, approx. 12:00am to my entire left arm numb. Woke up and numbness changed to tingling m. Tingling began to move up arm into neck and upper back then mid back. Then into left side of face and teeth. (No paralysis or Bells palsy - went away in 45 min) By Thursday morning tingling traveled to right right rib cage and feet, settling into hands and feet. Blurry, hard to focus vision. Went to ER on Thursday, 2/25. Not admitted. Discharged with recommendation to do MS workup. Tingling in hands turned to weakness in both hands on Friday. Left wrist and elbow joint pain. Tingling and numbness have persisted in hands and feet. Burning sensation on skin.
32 2021-03-11 hives 20 min after receiving vaccine reports hives on neck, swelling of tongue and slight difficulty swall... Read more
20 min after receiving vaccine reports hives on neck, swelling of tongue and slight difficulty swallowing. No breathing issues.
32 2021-03-12 skin warm, redness Arm swelling red and hot. Within 12 hours. Also severe muscle soreness of upper body. Tender to the ... Read more
Arm swelling red and hot. Within 12 hours. Also severe muscle soreness of upper body. Tender to the touch. Headache. All within 12 hours of the vaccine
32 2021-03-12 redness, hives Patient vaccinated and then later developed urticaria to bilateral lower forearms with erythema from... Read more
Patient vaccinated and then later developed urticaria to bilateral lower forearms with erythema from scratching. Given 10mg Zyrtec. After about 10 minutes urticaria improved, but 10 minutes later, erythema streaks appeared to bilateral upper arms, without scratching either area. EMT's and MD assessed patient, but patient refused to go to ED. Patient did state she has gotten hives from anxiety. Before leaving urticaria and erythema resolved. Patient ambulated out with husband without difficulty.
32 2021-03-13 injection site tingling, injection site pruritus Itching at injection site, tingling at site. BPs 156/98 (pulse 126), 127/90 (pulse 92). Ice pack rec... Read more
Itching at injection site, tingling at site. BPs 156/98 (pulse 126), 127/90 (pulse 92). Ice pack recommended for injection site.
32 2021-03-14 injection site pruritus, injection site nodule, injection site rash, skin warm 12 hours after injection: fever, joint aches, nausea, exhaustion lasting 1 day. Injection bump forms... Read more
12 hours after injection: fever, joint aches, nausea, exhaustion lasting 1 day. Injection bump forms on arm. 2 days after injection: hard knot in muscle of arm, radiates heat, and injection site is itchy.
32 2021-03-14 shingles, itchy skin 5 days after receiving the shot I had terrible pain in my abdomen and 2 spots that itched also on my... Read more
5 days after receiving the shot I had terrible pain in my abdomen and 2 spots that itched also on my abdomen. 8 days after receiving the shot I went to my doctor and was diagnosed with shingles. I am currently taking valacyclovir through March 19th. No more spots have emerged and the itching/pain is very mild but I am fatigued.
32 2021-03-14 skin warm Client received her first dose of the Pfizer vaccine and during the post-vaccination wait time, she ... Read more
Client received her first dose of the Pfizer vaccine and during the post-vaccination wait time, she complained of tingling, warmth and numbness in her tongue and lips. She denied trouble breathing and any itching or rash. She stated that she has a history of anxiety and is allergic to Zoloft, Ativan and mangoes. Her vital signs were as follows: BP=130/95; Pulse=115. ?911? was immediately called and they responded shortly thereafter with Engine number 305. She was evaluated, advised to take Benadryl if needed and was not transported to the hospital.
32 2021-03-14 injection site inflammation, injection site pain I had excruciating pain during the injection, which progressively worsened afterward reaching 10/10 ... Read more
I had excruciating pain during the injection, which progressively worsened afterward reaching 10/10 L shoulder pain within several hours of the injection. The L shoulder pain was so bad that I could not sleep that night, and the L shoulder pain was unrelieved with OTC Tylenol or Ibuprofen. I also noticed a new swollen lymph node under my left armpit the next morning. The L shoulder pain slightly decreased within 48 hours, but I have continued to have limited ROM of my left shoulder, a steady achey pain of my L shoulder, popping and crunching of my L shoulder with movement of my L shoulder, and difficulty abducting or flexing my L arm past 90 degrees since the injection. 2 weeks post-injection I saw an orthopedist who said my symptoms were caused from the vaccine injection and known as SIRVA (shoulder injury related to vaccine administration). He said I was injected too high, leading to injection of the vaccine material into my subacromial/subdeltoid bursa, causing persistent inflammation of the soft tissue leading to bursitis. He had to perform an US guided Toradol injection to attempt to calm down the inflammation caused from the injection. I have a 4-week follow up with the orthopedist in April. He indicated that an MRI may be required to further evaluate my shoulder.
32 2021-03-14 injection site pain Immediately after the shot, Pt. felt clammy, had blurred vision and tingling of both hands, then lo... Read more
Immediately after the shot, Pt. felt clammy, had blurred vision and tingling of both hands, then lost consciousness. Fell to floor, hit forehead, left knuckle and left knee. Was assisted to supine position and symptoms improved. (Admits to feeling anxious and not eating enough before the shot and feels that was related to her reaction.) Left facility after observation, and got food before driving self home. Reports soreness and stiff neck from fall injuries. Reports soreness of injected arm and the same "clamminess and sweating" the following morning with fatigue, but without the tingling, lasting only a few hours, then resolved with no further sequelae.
32 2021-03-14 rash papular, rash, skin warm, itchy rash, pain of skin, rash with redness, rash macular On day 11, I have a rash that appears to be similar to "Covid Arm", seen with the Moderna vaccine. I... Read more
On day 11, I have a rash that appears to be similar to "Covid Arm", seen with the Moderna vaccine. I have a round, raised, red, rash with irregular boarders. It is splotchey with patches of white. Currently it is roughly 2in wide and tall (marked to check for growth). It is excessively itchy, is tender to the touch, and is hot to the touch. Pain scale a 2-3 off a 1-10 adult scale. Overall feeling very tired and have an unproductive cough (could be allergies). Moderate headache.
32 2021-03-15 itchy skin It is making me itch all over but no hives, and it is messing with my asthma.
32 2021-03-16 shingles About 2 weeks after being vaccinated, I developed shingles. It kept me from work for about 7 days, h... Read more
About 2 weeks after being vaccinated, I developed shingles. It kept me from work for about 7 days, had to talk to the doctor and take valacyclovir.
32 2021-03-16 injection site hardening, injection site swelling, injection site pruritus, injection site pain, injection site mass Swelling at injection site that got worse a week after shot. 8 days later dull ache in full arm and ... Read more
Swelling at injection site that got worse a week after shot. 8 days later dull ache in full arm and hard, painfully, itchy lump at injection site. Pain in armpit (same arm as injection) started the same day as shot and continues to today (8 days later)
32 2021-03-16 shingles Symptoms of Shingles started to developed on March 13. Virtual visit doctor confirmed it is Shingles... Read more
Symptoms of Shingles started to developed on March 13. Virtual visit doctor confirmed it is Shingles and prescribed Valacyclovir HCL 1 Gram Tablet to take 1 table 3 times a day for 7 days. As of today, the symptoms are not better yet.
32 2021-03-19 injection site numbness, injection site pain, injection site tingling On Thursday March 11, 2021 I received my first dose of Pfizer COVID vaccine. Within about 5 second a... Read more
On Thursday March 11, 2021 I received my first dose of Pfizer COVID vaccine. Within about 5 second after administration I began to feel severe arm pain spreading from the injection site down to my fingers that were tingling and numb. Then within about 20 seconds of the vaccine I fainted. The fainting spell was brief, a few seconds, but the symptoms that continued after were long lasting. My blood pressure after was about 80/50, I was diaphoretic, pale, had moderate arm pain (tingling, numb, painful to move) and severe nausea. I was also light headed. These symptoms lasted through the night but I felt overall improved the next day other than fatigue and lingering arm pain. Then on March 16, 2021, 5 days later, I woke up with extreme fatigue. Over the course of the day I then began to get a headache. I got back in bed and then in the afternoon started to feel moderate arm pain again at the injection site and down the entire arm. Then severe nausea set in again along with more diaphoresis, chills and light headedness. The symptoms this time again lasted through the night and I felt better again the next morning.
32 2021-03-20 injection site pain, injection site redness, injection site warmth My right arm felt very heavy within an hr of vaccine. My arm in the deltoid area felt swollen like a... Read more
My right arm felt very heavy within an hr of vaccine. My arm in the deltoid area felt swollen like a body builder arm. Area of injection red circular warm to touch and tender. Forearm down to hand is puffy and tight feeling
32 2021-03-21 rash, skin irritation, redness, itchy skin I developed skin irritation and rash on my chest, neck, torso, arms, back, legs, pelvic region Thur... Read more
I developed skin irritation and rash on my chest, neck, torso, arms, back, legs, pelvic region Thursday evening, three days after receiving vaccine. This include severe itching, redness, inflammation, and visible red bumps. The symptoms are not getting better, so I visited the Dr.. I was tested for COVID to make sure I was not exposed after the vaccine, and the results were negative for COVID. She prescribed me prescription strength cream, because the Cortisone cream, in combination with Zyrtec and Benadryl are not working. She did not want to give me anything stronger due to concerns of hindering the effect of the vaccine. It appears to be a mild allergic reaction, but is extremely unpleasant. I cannot stop scratching no matter how hard a try and it is all over my body.
32 2021-03-23 hives Dizziness - Started at 5:30am lasted 11hrs. I had to sit/laydown that entire time, moving around mad... Read more
Dizziness - Started at 5:30am lasted 11hrs. I had to sit/laydown that entire time, moving around made it worse. Nausea - lasted 4-5hrs. Chills - started at 4pm, temperature was 98.5. Hives - Started around 4pm 03/23/21 and are still cover half my body.
32 2021-03-23 injection site pain, injection site reaction Received the shot at 2:30PM....started experiencing increasing pain at injection site from 8-10PM. A... Read more
Received the shot at 2:30PM....started experiencing increasing pain at injection site from 8-10PM. At 1AM started experiencing tingling and numbness from left arm all the way down to left toes.
32 2021-03-23 redness, rash Redness and swelling of the face, rash on chest arms, and face. Tingling and numbness in face. Subsi... Read more
Redness and swelling of the face, rash on chest arms, and face. Tingling and numbness in face. Subsided with taking Claritin and Benadryl over the counter
32 2021-03-24 itchy skin, injection site swelling I still had lingering back pain and the feeling that something was sitting on my chest since the fir... Read more
I still had lingering back pain and the feeling that something was sitting on my chest since the first dose of my vaccine. The day after the dose of the vaccine I had a headache and body aches with severe back pain in my lower and mid back. My arm became swollen to the size of a baseball around the site of injection. It was a lump on the side of my arm and my arm was numb every once in a while. My arm was very painful and swollen and itchy. I had the issues with my arm for 10 to 14 days after each dose of the vaccine. I have been having severe backache and like something is sitting on my chest. I still very fatigued after 10 weeks and I have severe back ache. I have been using Lidocaine for the pain and Naproxen and a muscle relaxer at times.
32 2021-03-24 injection site warmth, injection site pain Pfizer-biontech covid-18 vaccine eua. Injection site was immediatly burning. Afer 1 hour burning we... Read more
Pfizer-biontech covid-18 vaccine eua. Injection site was immediatly burning. Afer 1 hour burning went away and turned to injection site soreness. At 10 pm I started feeling achey and having chills. Nausea followed. I vomitted every 30 minutes from 10:20pm(march 20) to 530am(march 21). I had a fever, ranging from 99.5 tp 100.5 from 10 pm on march 20th until 2pm march 22nd. My body was achey everywhere from march 20th to march 23rd. I was very tired from March 21 to march 23. Today. March 25 my injection site is still semi sore but all other side effects have subsided.
32 2021-03-24 injection site swelling, itchy skin, injection site numbness, injection site mass The day after the dose of the vaccine I had a headache and body aches with severe back pain in my lo... Read more
The day after the dose of the vaccine I had a headache and body aches with severe back pain in my lower and mid back. My arm became swollen to the size of a baseball around the site of injection. It was a lump on the side of my arm and my arm was numb like maybe a nerve was damaged. My arm was very painful and swollen and itchy. I had the issues with my arm for 10 to 14 days after each dose of the vaccine. I have been having severe backache and like something is sitting on my chest. I still very fatigued after 10 weeks and I have severe back ache. I have been using Lidocaine for the pain and Naproxen and a muscle relaxer at times.
32 2021-03-24 injection site redness, rash macular The patient is a healthy 32 yo with a history of AE after Pfizer Covid vaccine #2 (lot #EL1284, rec... Read more
The patient is a healthy 32 yo with a history of AE after Pfizer Covid vaccine #2 (lot #EL1284, receipt 06 January). She reports receipt of vaccine at about noon. She developed nausea about 30 minutes later. She developed headaache about 1-1 1/2 hours later. She fetl lethargy and fatigue about 4-5 pm and was asleep by 18:00. She slept through until noon the next day when her mother awoke her due to concern for her breathing pattern. She said she felt exhausted and unwell like 'a terrible hangover'. She could not stand and her limbs felt weak and flaccid. Family called the nurse help line who instructed to call EMS. She was soaked in sweat, but no fever and reports she was told her BP was elevated, her extremities were numb but tingled as they improved, and she recalls very severe headache and breathing was hard due to feeling 'heavy'. She felt better as she got near the hospital. She notes her recall of the events is hazy. She was treated with IVF and Toradol and discharged with tylenol, motrin and zofran. She denies emesis, but recalls severe myalgias, knee arthralgias which continued with fatigue for about 10 days, and still has discomfort to her right knee. She reports chest tightness with exertion, which resolved. She denies cough, diarrhea, or any immediate reaction suggestive of IgE. She reports local site reaction of erythematous plaque with smaller peripheral macules, centrally located at the injection site with smaller macules peripherally down her arm. She denies history of AE with other vaccines. Per ER notes, states EMS report HR 114, diaphoretic, HTN,, febrile, tachypneic, received 500 cc bolus. Triage states crying, anxious and tachypnic, guided in deep breathing, BP 95/65, HR 100, RR 26 sat 97%, T 98.3; documented as ill appearing. cc: fatigue, weakness, sweating, nausea, malaise, headache. Only diagnostic is EKG which was normal. She was treated with Ofirmev, in addition to IVF and Torrodol.
32 2021-03-25 skin spots A few weeks after the vaccine I noticed my legs were covered in Peticia which began spreading up the... Read more
A few weeks after the vaccine I noticed my legs were covered in Peticia which began spreading up the legs. I was sent to the ER for a CBC but was sent home. My Dermatatologist performed 2 Punch Biosypies. I began having joint pains in my legs and stomach pains. The peticia begin going and coming. And the test results for the Punch Biopsies revealed I had HSP "Henoch Schonline". I began having GI issues with bloody stool, blood in my urine which prompted I be started on a high dose Steroid of Prednisone. On 3/24 I saw a Nephrologist who advised there was still blood in my urine and a kidney biopsy may have to be perfomed if the steroids does not improve or resolve the issue. Ive been having nose bleeding also but is unsure if its associated as well and I am scheduled to see and ENT for on 4/2 for that.
32 2021-03-25 itchy skin Patient reported itching on arm first, then "all over" about 20 min after administration. She denied... Read more
Patient reported itching on arm first, then "all over" about 20 min after administration. She denied Benadryl due to extreme drowsiness. She did state that the itching "may be in my head". I watched her for 20 more minutes. She stated she is fine and good to leave. I asked her to call if anything outside of her normal happens.
32 2021-03-26 rash with redness, itchy rash A day after had severe chills, body aches all over, fatigue, headaches, nausea, vomiting. Two days a... Read more
A day after had severe chills, body aches all over, fatigue, headaches, nausea, vomiting. Two days ago started having bumps on skin on the arms, back, and legs, and few on belly with red dots. It itches not a lot. I want to know if it?s ok to take 2nd dose of Pfizer vaccine.
32 2021-03-26 injection site mass, injection site pain Developed arm pain that is mild but occurs when lifting arm above head especially with heavier objec... Read more
Developed arm pain that is mild but occurs when lifting arm above head especially with heavier objects or when brushing hair. Have a lump beneath injection site that when pressed on is tender and has nerve pain associated with it down arm into hand.
32 2021-03-26 injection site redness, injection site pain, injection site swelling Injection site pain, tiredness, headache, muscle pain, joint pain, injection site swelling and redne... Read more
Injection site pain, tiredness, headache, muscle pain, joint pain, injection site swelling and redness, and swollen lymph nodes
32 2021-03-28 injection site pain ? injection site pain ? tiredness ? headache ? muscle pain ? chills ? joint pain ? nausea ? feeling... Read more
? injection site pain ? tiredness ? headache ? muscle pain ? chills ? joint pain ? nausea ? feeling unwell ? swollen lymph nodes (lymphadenopathy)
32 2021-04-08 rash, skin spots bilateral joint pains in wrist, metacarpals, and ankles followed by bilateral petechial rash in lowe... Read more
bilateral joint pains in wrist, metacarpals, and ankles followed by bilateral petechial rash in lower extremities.
32 2021-04-17 vaccination site pain mental fogginess; Severe vertigo; rocking; dizziness; disorientation; Moderate injection site pain; ... Read more
mental fogginess; Severe vertigo; rocking; dizziness; disorientation; Moderate injection site pain; fatigue; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8730), via an unspecified route of administration in the right arm on 30Mar2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient was not pregnant. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient experienced severe vertigo (rocking and dizziness), disorientation, mental fogginess, moderate injection site pain and fatigue; all on 01Apr2021 at 06:00 AM. Treatment was received for events including medication and rest. Event resulted in [Doctor or other healthcare professional office/clinic visit]. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of the events was not recovered.
32 2021-04-20 injection site redness, injection site swelling, injection site pruritus I had no symptoms 4 days post-vaccine. Then, 8 days after receiving the vaccine, the injection site... Read more
I had no symptoms 4 days post-vaccine. Then, 8 days after receiving the vaccine, the injection site swelled again, and became red and itchy. It looks like a giant bug bite.
32 2021-04-21 skin mass I felt an nodule on my left collarbone its was moving while I moved my neck , It is not painful and ... Read more
I felt an nodule on my left collarbone its was moving while I moved my neck , It is not painful and pea sized I didn?t get it checked by a doctor yet
32 2021-04-25 rash Approx 26 hours after injection, noticed large circular rash on both armpits. Very painful.
32 2021-04-26 injection site pain 100.0 fever; Chills; body ache; left armpit lymph node; site of injection sore; fatigue; This is a s... Read more
100.0 fever; Chills; body ache; left armpit lymph node; site of injection sore; fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El3247) via unspecified route of administration on Left arm on 16Feb2021 (at the age of 32 years old) as single dose for COVID-19 immunization at workplace clinic. The patient medical history was none. The patient had no known allergies. Concomitant medications included ethinylestradiol/ norgestimate (SPRINTEC) and escitalopram. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El2347) on Left arm on 27Jan2021 01:45PM for COVID-19 immunization. The patient did not receive any other vaccines in four weeks. The patient did not have COVID prior vaccination and did not tested for COVID post vaccination. On 17Feb2021 at 02:00 AM, the patient experienced chills, body ache, left armpit lymph node, site of injection sore, fatigue and 100.0 fever. The patient did not receive any treatment for the events. The outcome of the events was reported as received on an unspecified date in 2021.
32 2021-04-26 injection site pain Site: Pain at Injection Site-Medium, Additional Details: pt recieved covid vaccine today...verified ... Read more
Site: Pain at Injection Site-Medium, Additional Details: pt recieved covid vaccine today...verified location of the shot and it is right in the right deltoid of the right arm. pt immidiately after felt pain at the injection site that radiates to her hand. it has persisted for at least 30 minutes while we monitored pt in store. pt says its hard to hold things because of pain by forearm. referred pt to see primary care to see if any additional treatment is needed
32 2021-05-03 hives I was admitted to the ER with a complex migraine and parathesia in my right arm; I was admitted to t... Read more
I was admitted to the ER with a complex migraine and parathesia in my right arm; I was admitted to the ER with a complex migraine and parathesia in my right arm; after about three days of flu-like symptoms; after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); My throat felt restricted; I had hives and raised bumps and bruising on my left arm where the shot went in; I had hives and raised bumps and bruising on my left arm where the shot went in; I was having difficulty breathing; my body felt like it was swelling up everywhere; allergy symptoms manifest/allergic reaction; I had the normal side effects of numbness and soreness in my left arm; I had the normal side effects of numbness and soreness in my left arm; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient (No pregnant) received 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: ER8737) on 05Apr2021 06:15 PM at single dose on Left arm for covid-19 immunization. Medical history was Immunocompromised, chronic migraines. Known allergies: Just seasonal allergies. Wheat and soy allergy, restricted diet. Concomitant medications (in two weeks) included fluticasone propionate (FLONASE) for allergies (nasal spray), mirtazapine (REMERON). No other vaccine in four weeks. Patient stated that I had the normal side effects of numbness and soreness in my left arm from 05Apr2021. Three days later I had allergy symptoms manifest, Thursday (the shot was on a Monday), and had to go get allergy medication. My throat felt restricted, I was having difficulty breathing, and my body felt like it was swelling up everywhere. I had hives and raised bumps and bruising on my left arm where the shot went in from 09Apr2021 ( reported as 08Apr2021 12:00 PM). Swelling noticeably went down after the allergy medication and breathing returned to normal. On Tuesday, 13Apr2021, after about three days of flu-like symptoms (nauseau, tiredness, body aches), I was admitted to the ER with a complex migraine and parathesia in my right arm, though the shot was in my left arm, and the migraine was in my left side of my head. I feel that this was an allergic reaction that happened belatedly and is a much stronger reaction than anyone else I have seen take the same dose and the same vaccine. AE resulted in Emergency room/department or urgent care. Treatment was Allergy medication from 08Apr2021 to 13Apr2021 two IV's + Benadryl. Outcome of the event was Recovering. No Covid prior vaccination. No Covid tested post vaccination. No follow-up attempts needed. No further information expected.
32 2021-05-11 itchy skin Bell's Palsy; swollen tongue; itchiness; This is a spontaneous report from a contactable consumer (p... Read more
Bell's Palsy; swollen tongue; itchiness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 14:30 (Batch/Lot Number: EL9262) (at the age of 32 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included immunoglobulin g4 related disease (IGG4-RD) and rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took rituximab (RITUXAN) and experienced drug allergy and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686) in the left arm on 07Jan2021 at 02:30 pm for COVID-19 immunization and experienced rash in face and back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 01Apr2021, the patient experienced Bell's Palsy, swollen tongue and itchiness. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 3 days. The patient received treatment for the reported events. Since the vaccination, it was unknown if patient has been tested for COVID-19. The outcome of the events was recovering.
32 2021-05-11 skin irritation Vomiting; chills; sweating; fever; extreme joint pain (especially in my knees); extreme skin inflamm... Read more
Vomiting; chills; sweating; fever; extreme joint pain (especially in my knees); extreme skin inflammation pain; pain; restlessness; nausea; gassiness; piercing headache; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included bipolar 2, allergies to red dyes, and detergents. The patient is not pregnant at time of vaccination. Concomitant medication included lamotrigine (LAMICTAL); trazodone; fluoxetine and multiv. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 11:00 (Batch/Lot Number: ER2613) for covid-19 immunisation. The patient experienced vomiting, chills, sweating, fever, extreme joint pain (especially in her knees), extreme skin inflammation pain, restlessness, nausea, gassiness, piercing headache, muscle aches all on 15Apr2021 19:00. Symptoms onset 8 hours post second dose, went away by hour 20 post second dose, except for splitting headache which lingered for several days. Tylenol taken on regular schedule didn't kill pain. Alternated rosin salt bath/hot shower through the night. No treatment was received for other events. All events were serious. Prior to vaccination, no patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The outcome of event headache was unknown, while other outcomes of events were recovered. No follow-up attempts are needed. No further information is expected.
33 2020-12-31 injection site pain I had a small burning sensation after the initial injection near the injection site. Felt fine for t... Read more
I had a small burning sensation after the initial injection near the injection site. Felt fine for the rest of the morning and afternoon. In the evening I started to feel feverish. It was at 99.5. When I woke up this morning my fever had progressed to 101.8. I do have soreness near the injection site as well.
33 2020-12-31 pain of skin, shingles, itchy skin I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body ache... Read more
I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body aches mostly on my left side. On 12/25, I started having a strong headache, focused mostly on the left side. On 12/26 the headache continued and I also noticed swollen lymph nodes on both sides of my neck, and behind my ears. Also, it felt like someone had broken my nose and when I would try to bite down or chew I would have a sharp pain and pressure in my nose and sinuses. On 12/27, the headache continued, and I had severe left eye pain, as well as pain chewing and the swollen nodes, that became painful to touch. On 12/28, I went to my PCP and was tested for covid, which was negative. She diagnosed me with a sinus infection and prescribed amoxicillin. On 12/29, I noticed my scalp had lumps on it that were painful and I had a very itchy spot on my forehead, which became swollen as well to about a quarter size lump. I also had other painful spots on my scalp all over and a continued severe headache and left eye pain. I tried to follow up with my PCP on 12/31, but their office was closed, and the on call nurse referred me to urgent care. More painful, swollen lymph nodes have appeared on my face and neck. I wasn't able to be seen at urgent care until today (1/1), and was then diagnosed with Shingles. I was told to continue amoxicillin and to start taking Valtrex. I am very itchy, mostly on my face, scalp, and left side of my body.
33 2020-12-31 injection site redness, injection site warmth, injection site swelling Persistent nausea x48 hours, so far. Half dollar size red, warm, swollen area at injection site sinc... Read more
Persistent nausea x48 hours, so far. Half dollar size red, warm, swollen area at injection site since 12 hours post injection. No fevers.
33 2021-01-01 hives, injection site reaction, injection site pain Large welt from injection site. Increasing pain in arm that received the vaccine. It began as just a... Read more
Large welt from injection site. Increasing pain in arm that received the vaccine. It began as just around the actual injection site. It has been 9 days and the pain has slowly increased and now aches from the injection site, my entire bicep muscle, and just below my elbow
33 2021-01-02 redness, hives, rash Hives red dot rash swollen eyes and face
33 2021-01-03 rash macular, itchy skin 15 min after the vaccine I was flushed and felt hot , ears felt hot as well. I had a macular rash ... Read more
15 min after the vaccine I was flushed and felt hot , ears felt hot as well. I had a macular rash on chest and arms. My throat felt itchy and they immediately gave me benedryl. I was tahycardic as well. When I got home from the ER that night I had to take more benedryl and then the next morning I was still itchy and my voice was hoarse so I took more xyzal and famotidine. The rash subsided and I continued taking xyzal twice a day , benedryl and famotidine for a week. After my vaccine the itching did not subside for about 48 hours and it was very difficult to control. I had to take max doses of antihistamines to control the hoarseness In my voice and itching
33 2021-01-03 itchy skin C/o itching immediately following vaccine admin. Benadryl 50mg x 1 po admin per S.O.
33 2021-01-03 rash General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Ras... Read more
General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Rash on chest/neck; This is a spontaneous report from a contactable Pharmacist. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscularly on 22Dec2020 13:15 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. None medical history. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced rash on chest/neck. General weakness requiring assistance to stand on 22Dec2020 17:00 with outcome of recovered in Dec2020. The date report was first received from source was 23Dec2020. Patient received Fluid bolus, IV benadryl, IV steroid as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The events were reported as non-serious.; Sender's Comments: The reported events rash on chest/neck and general weakness requiring assistance to stand were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-01-03 injection site pain High fever, headache, tenderness at injection site.
33 2021-01-03 rash Mild rash with first dose of Pfizer-BioNTech COVID 19 vaccine. Evaluated in ED for rash. Gave diphe... Read more
Mild rash with first dose of Pfizer-BioNTech COVID 19 vaccine. Evaluated in ED for rash. Gave diphenhydramine 25 mg PO and observed for 1 hour. Patient felt comfortable discharging and returning if symptoms worsened.
33 2021-01-03 injection site mass, injection site swelling, injection site pruritus, injection site redness, injection site warmth Patient reported a small tender lump at the site of the injection and she stated this is similar to... Read more
Patient reported a small tender lump at the site of the injection and she stated this is similar to what she experiences with other vaccines. On December 30th, she reported that on 12/28 in the evening, she started feeling itchy at the site of the injection. On 12/29/2020, the area looked red and warm and had grow to the size of a "clementine". The patient took one dose of non-drowsy antihistamine and by the 30th the erythema improved. I spoke with the patient today, 1/4/2021, and all symptoms have resolved.
33 2021-01-03 redness, itchy skin Symptoms - Felt hot and nauseas, difficult to swallow, itchy skin. Vax admin said I had red patches ... Read more
Symptoms - Felt hot and nauseas, difficult to swallow, itchy skin. Vax admin said I had red patches on face. Took vitals. Administered Benadryl. Monitored for 1.5 hours. Still itchy. Went home, took more Benadryl. Itchiness subsided by the following day.
33 2021-01-03 injection site bruising mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from ... Read more
mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from non-contactable Pharmacist (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at right arm on 19Dec2020 08:15 at single dose for Covid-19 immunization. The Covid-19 vaccine was administered in a hospital facility. Medical history included seasonal allergies, heartburn, and allergies to ethanol. The patient has no Covid prior vaccination. Concomitant medication included cetirizine, esomeprazole, melatonin; all from unspecified date for unspecified indication. The patient did not receive other vaccines in four weeks prior to the Covid vaccine. On 19Dec2020 at 15:00, the patient experienced bruising of injection site (x 1 week), arm pain, fatigue, mental cloudiness (approximately x 1 day). The patient was not tested post vaccination. The patient did not received treatment due to the events. The outcome of the events mental cloudiness, bruising of injection site, arm pain and fatigue was recovered in Dec2020. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event mental impairment cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
33 2021-01-04 itchy skin, injection site swelling, redness, injection site redness 25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and i... Read more
25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and itchy. II was taken to the Emergency Department for further observation. I I also experience some nausea, my tongue was slightly itchy, I had a stomach ache and some redness/swelling round the injection site. At the ED I was given 25 md Benadryl PO and observed for another hour and a half before being discharged.
33 2021-01-04 skin reaction, injection site redness, injection site pruritus, injection site warmth, injection site swelling I had a localized skin reaction for 2-3 days after receiving vaccine ( redness, itching, swelling at... Read more
I had a localized skin reaction for 2-3 days after receiving vaccine ( redness, itching, swelling at and around injection site), which went away after a few days. Today (9 days after vaccine) my skin reaction has returned and is more prevalent than it was the first time. It is very red, swollen, itchy, and hot to the touch.
33 2021-01-04 cellulitis, injection site redness, injection site hardening, injection site swelling, injection site warmth Injection received in left upper arm. Injection site was quite low on the arm. Redness, swelling, ... Read more
Injection received in left upper arm. Injection site was quite low on the arm. Redness, swelling, and warm to touch.
33 2021-01-04 itchy skin Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole ... Read more
Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole body. did not think much of it. woke up once in middle of night at 4am with racing heart but went back to sleep. Around 9 am next morning started getting chills, initially mild then severe and developed severe myalgias; could not get out of bed or lift arms or limbs. having chest tightness and shortness of breath. pressing on chest wall hurts, hard to take deep breath. Temps of 99.5 most of morning. started taking tylenol total of 1 gram. 1 hour after tylenol shaking and rigors with sweating. had temp of 101 after tylenol. HR 110 at this time (my baseline is around 60s). O2 sat remained normal. Went to ER for testing for covid in case this was covid--test negative. Felt a little better morning of 1/4--no fever. tried to work 1/2 day; called out sick. lots of brain fog, fatigue mental slowing. still having intermittent chest tightness and sob; feel like i cannot expand my lungs. deep breath makes me cough. had few small red bumps on left antecubital fossa that resolved. i'm a physician, i'm concerned this was a severe reaction and was advised to report this.
33 2021-01-04 itchy skin itching lower extremeties less than 30 minutes. no rash involved
33 2021-01-04 rash macular tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residu... Read more
tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residual mild chest discomfort and noticed 2 blotches on chest in car; metallic taste in mouth; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via Intramuscular on 28Dec2020 12:30 PM at single dose in the arm left for COVID-19 immunisation. Medical history included Bee venom (anaphylaxis), hereditary fructose intolerance (HFI, HFI as above but no previous issues with sucrose containing vaccines) and Known allergies: Bee venom (anaphylaxis). Concomitant medications included Linaclotide, Adderall, polyethylene glycol 3350. Roughly 5-7 minutes after injection, the patient experienced palpitations, chest tightness, and metallic taste in mouth - sensations mostly subsided after another 5 minutes so did not report. Left center after 30 mins, the patient had residual mild chest discomfort and noticed 2 blotches on chest in car. Drove home - on the way at 13: 15 (45 mins post vaccine), developed throat swelling, severe chest tightness, tachycardia (HR 130s), and dizziness. Severe symptoms (throat swelling particularly) subsided after 5 minutes but other symptoms persisted for another hour. Used albuterol, had epi pen ready but didn't use. Now 3 hours out, feeling close to baseline. The patient underwent lab tests, which included Covid test post vaccination with Negative result in Dec2020. The patient received treatment for events, which included Albuterol. Outcome of events was recovering.
33 2021-01-05 injection site pain Headache, Myalgia, NauseaVomiting, Injection site pain Headache 5 minutes after injection. Nausea an... Read more
Headache, Myalgia, NauseaVomiting, Injection site pain Headache 5 minutes after injection. Nausea and vomiting 1 hour after injection. Body aches and injection site pain also reported.
33 2021-01-05 vaccination site redness, itchy skin, hives Hives to opposite arm; redness to injection site; Itching; This is a spontaneous report from a conta... Read more
Hives to opposite arm; redness to injection site; Itching; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685, expiry date not reported), intramuscular in 30Dec2020 09:00 at a single dose in the left arm as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient had no known allergies. The patient had no allergies to medications, food, or other products. The patient had no COVID prior vaccination and patient was not tested for COVID post vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 09:15, the patient experienced hives to opposite arm and redness to injection site, and itching. Started within 20 minutes, patient taken to the emergency room/department or urgent care for evaluation and medications. As treatment, patient received diphenhydramine, famotidine, prednisone in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the events hives to opposite arm and redness to injection site, and itching was unknown.
33 2021-01-05 itchy skin Itching to legs, torso, and arms that is persisting at time of report.
33 2021-01-05 itchy skin Symptoms - ? patient reports itchiness to bilateral forearms approximately 45 after vaccination
33 2021-01-06 injection site reaction After 6-10 minutes of the injection , I started having shooting pain from the injection site, throug... Read more
After 6-10 minutes of the injection , I started having shooting pain from the injection site, through my left clavicle area to around the back of my neck. After 15 minutes those muscles described started tensing and my muscles in the back of my neck tightened to the point I can?t look left to right (turning motion). It?s now Almost 3 hours after and symptoms remain same.
33 2021-01-06 injection site reaction, injection site pain I have had extreme muscle pain and tightness in my left arm, shoulder and neck since 12-30-2020.
33 2021-01-06 injection site mass Patient's arm was feeling tight after the injection, The sleeve seemed to be tightening her arm and ... Read more
Patient's arm was feeling tight after the injection, The sleeve seemed to be tightening her arm and after the injection she felt all the blood rush down her arm and she stated the injection site came out a bit and had a little bump. She went to the observation area and was feeling faint and light headed. She was taken to a separate room and she became a little faint and was given some water and kept longer for observation. After about an hour shes feeling much better and her color as returned and only feeling slightly light-headed.
33 2021-01-06 rash SkinRash COLD SENSATION RADIATES DOWN LEFT ARM Narrative:
33 2021-01-06 injection site pain Vaccine received at 3:00 PM on 1/4/2021 10:00 PM: fatigue 1/5/2021: 01:45 AM: Fever 104 F, Chills, B... Read more
Vaccine received at 3:00 PM on 1/4/2021 10:00 PM: fatigue 1/5/2021: 01:45 AM: Fever 104 F, Chills, Body aches, headache, severe pain in arm of injection. 04:00 AM: Fever 101 F 08:00 AM: Fever 100.4 F. Tylenol taken. Headache and body aches throughout the day. 1/6/2021: headache and body aches most of the day ALL Symptoms gone by 48 hours post vaccine
33 2021-01-07 itchy skin 4: 50 pm - 20 minutes after injection, pt reports feeling flushed, hot and itchy. pt denies breathi... Read more
4: 50 pm - 20 minutes after injection, pt reports feeling flushed, hot and itchy. pt denies breathing trouble. 5: 03 pm pt was evaluated by EMS BP 162/105, P91, O2 sat 100%, EKG done 5: 09 pm BP 136/84 P 86, O sat 100 %. Pt reports reports feeling better, declined transport to ED. Pt left AMA.
33 2021-01-07 rash Benadryl 25mg taken at 1620 Vaccine #2 given at 1630 Rash developed on forearms with chest tightness... Read more
Benadryl 25mg taken at 1620 Vaccine #2 given at 1630 Rash developed on forearms with chest tightness and "feeling strange" at 1643, temp 99.2F Throat became itchy at 1650 1654 Vitals: 119/63 MAP 81, RR 20 SpO2 98% RA, 98.2F Lungs clear, rash has not spread as of 1654 Transfer care to ED 1656 Admitted early morning after discharge from ED due to increase in sxs. Unable to enter Hospital Name under 21. Unknown days, Hospital same as giving facility.
33 2021-01-07 injection site pain Deltoid ache which has since resolved. Ache in Shoulder/axillary joint, has continued through today ... Read more
Deltoid ache which has since resolved. Ache in Shoulder/axillary joint, has continued through today (3 weeks since the Vaccine dose). Hurts when I left my arm above shoulder height
33 2021-01-07 rash, itchy skin Developed rash, itching on arm and on chest, tingly feet and dry cough, dry mouth
33 2021-01-07 vaccination site pain Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain... Read more
Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Eh9899), intramuscularly in left arm on 15Dec2020 16:00 at single dose for COVID-19 immunization. There was no medical history (Known allergies (Allergies to medications, food, or other products): No). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: No. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient experienced injection site pain 12 hrs post injection, myalgias, chills, fatigue at 24 hrs on 16Dec2020 07:00 with outcome of recovered. The patient received treatment ibuprofen for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. AE was not resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Serious: no. Seriousness criteria-Results in death: no. Seriousness criteria-Life threatening: no. Seriousness criteria-Caused/prolonged hospitalization: no. Seriousness criteria-Disabling/Incapacitating: no. Seriousness criteria-Congenital anomaly/birth defect: no.
33 2021-01-07 rash Rash to face and lips, periorbital edema, all lasting 1 week, has not fully resolved. Taking benadry... Read more
Rash to face and lips, periorbital edema, all lasting 1 week, has not fully resolved. Taking benadryl and hydrocortisone cream
33 2021-01-07 hives, rash Rash/hives on face
33 2021-01-07 redness, injection site warmth Redness, swelling, warmth at injection site, area ~2 in by 4 in on 1/8/21 and was about half the wid... Read more
Redness, swelling, warmth at injection site, area ~2 in by 4 in on 1/8/21 and was about half the width and length on 1/7/21.
33 2021-01-07 hives Swelling of tongue, lips and face. Hives. Benadryl administered on site. Rapid Response team call... Read more
Swelling of tongue, lips and face. Hives. Benadryl administered on site. Rapid Response team called. Patient was transported to ED. In ED received IV solumedrol, IV fluids and EPI X 1. Full recovery. Discharged from ED to home on 4 days of prednisone.
33 2021-01-07 rash, hives With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very ... Read more
With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very hot, I started to sweat and then my throat started to dry up and close. I notified the provider on watch that was monitoring me during my 15 mins after injection and as the walked me to the room I became more and more dizzy, my throat continued to swell and close, my mask was removed where my face was covered with a rash and hives . The dr. Gave me 50 mg benedryl, and a shot of epinephrine. After wards 911 was called, my heart rate was eventually brought down with the epinephrine as my symptoms began to be controlled. An inhaler was administered because I was short of breath. 3 hours later I was stabilized. I then was recommended to go to urgent care rather the emergency room since the wait was 13 hours to be monitored at the local hospital MLK. I went to urgent care near my home at Hoag hospital and they monitored me and gave me a steroid injection IM. I was discharged with an epi pen just in case abs to take benedryl every 6 hours . The following morning 1/8/21, at 8 am the swelling of my throat retuned I became light headed abs my tongue became numb. I was taken to fountain valley hospital where an IV was started, 500 mg of iv benedryl, another epinephrine injection was given abs I remained under surveillance for another 6 hours. They stated that a lot of people are coming with reoccurring episodes of anaphylaxis after the phizer injection.
33 2021-01-07 vaccination site pain muscle pain; cough; fever/have high fever above 102; injection site pain; This is a spontaneous repo... Read more
muscle pain; cough; fever/have high fever above 102; injection site pain; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on right arm on 28Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history was reported as none. Patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient reported she experienced symptoms like fever, injection site pain on 28Dec2020 (also reported as 09Dec2020, for clarification), muscle pain on an unknown date, and cough in Jan2021. She had high fever above 102 on 29Dec2020, one day after the vaccination and on the 5th day she started to cough. Patient did not receive any treatment for the events. Outcome of the events was not recovered. Information on the Lot/batch number has been requested.
33 2021-01-08 injection site redness, injection site swelling, injection site pruritus Day 11 post vaccine (1/8/2021) a large red, swollen, itchy circular area showed around vaccine injec... Read more
Day 11 post vaccine (1/8/2021) a large red, swollen, itchy circular area showed around vaccine injection site. Larger than a quarter but smaller than a softball size. Benadryl and hydrocortisone needed.
33 2021-01-08 injection site pain Day 1: Chills, severe pain in injection site arm including muscular and joint pain. Pain down entire... Read more
Day 1: Chills, severe pain in injection site arm including muscular and joint pain. Pain down entire arm radiating up neck. Day 2: fatigue, dizzy, lightheaded Day 3: vomiting Day 4: vomiting and severe headaches
33 2021-01-08 hives Extreme arm fatigue and limited range of motion, hives and flushing of face and ears
33 2021-01-08 hives Headache, extreme lethargy, full body hives, eyes swollen . Symptoms lasted for about 48 hours.
33 2021-01-08 injection site irritation, injection site pain, injection site redness I experienced soreness of left arm in a couple of hours after the shot with mild irritation and redn... Read more
I experienced soreness of left arm in a couple of hours after the shot with mild irritation and redness on the injection site, but symptoms all went away in 1-2 days. However, in one week after the vaccination (1/5/21), I started to develop lymphadenopathy under my right arm, and fatigue.
33 2021-01-08 rash with redness, rash, itchy rash Pt developed a large red itchy rash on her neck / chest area, she stated she felt fine but was obser... Read more
Pt developed a large red itchy rash on her neck / chest area, she stated she felt fine but was observed trembling. She was transported to ED (5 min transport) She was treated with: Benadryl 25mg IV X1, Solumedrol 60mg IVX1, famotidine 20mg IV X 1 - diagnoses was allergic reaction Pt improved after treatment She was observed from 09:11 until 10:33
33 2021-01-08 injection site pain, injection site redness, itchy skin, injection site swelling Several minutes after getting the shot, my chest started to feel tight and I needed to use my rescue... Read more
Several minutes after getting the shot, my chest started to feel tight and I needed to use my rescue inhaler. I stayed at the Clinic until 30 minutes had been up. When I arrived home I needed to use my Albuterol Nebulizer Solution, and started to get slightly itchy. My chest didn't start to feel better until after 2am, and the next day I noticed my arm at the injection site was swollen and slightly red. It is still red to this day and it feels achy all the way to my wrist.
33 2021-01-10 injection site swelling 1). Headache (on &off) since 1/6. Tylenol and ibuprofen seem to be effective. 2). Fever with Temper... Read more
1). Headache (on &off) since 1/6. Tylenol and ibuprofen seem to be effective. 2). Fever with Temperature btn 99-100.3 these past three days. 3). Pulse (btn 104-110) the night of 1/6. 4). Muscle aches and swelling at injection site. This has been my biggest obstacle. I am having a hard time lifting and typing. . - I have been utilizing ice packs, range of motion/exercise, ibuprofen.
33 2021-01-10 injection site pruritus, injection site redness, injection site pain, injection site swelling, injection site warmth I received second covid vaccine on 11/8/21 at 7:45am. That night around 7:30pm I started experiencin... Read more
I received second covid vaccine on 11/8/21 at 7:45am. That night around 7:30pm I started experiencing body aches and chills. The morning of 1/9/21 I developed a fever, head ache and noticed a red, tender area the size of a penny at the injection site. During the weekend the area around the injection site continued to grow. 1/11/21 I noticed the area is itchy, red, tender/tight feeling, and warm. Pain only when the area is touch. This area is 3.5inchs W by 3 inchs L.
33 2021-01-10 itchy skin, skin burning sensation On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my... Read more
On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my left neck and arm to the point of injection site. My left arm was also sore as to be expected with typical injection but this sensation was different. It caused a sharp neuromuscular pain that was also itchy/burning. Extended in the region of sternocleidomastoid site. No rash development but seemed like symptoms of shingles. Continued through until approx 12/26/20. Improved with heat pack, Tylenol and Motrin. Was evacuated by physician on 12/21/20 with no testing or medication provided as symptoms were unclear.
33 2021-01-10 injection site pruritus, injection site redness, injection site swelling Red, swollen, itchy arm for 4days straight Migraine day 2 Fever 102 afternoon of day 2 with chills ... Read more
Red, swollen, itchy arm for 4days straight Migraine day 2 Fever 102 afternoon of day 2 with chills and pins and needles sensation over entire body weakness/tiredness late afternoon
33 2021-01-10 injection site warmth, injection site pain, injection site redness Redness and heat at injection site, continued soreness.
33 2021-01-10 injection site redness, injection site pain Redness at site of injection, pain at site of injection, fever/chills, joint aches
33 2021-01-10 injection site redness, injection site warmth, injection site swelling, injection site pruritus Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on... Read more
Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on 2nd day with chills and tingly/prickly feeling all over, weakness/dizziness
33 2021-01-11 skin warm 24 hours after inj L axillary LN enlarged about the size of a baseball very tender and warm to the t... Read more
24 hours after inj L axillary LN enlarged about the size of a baseball very tender and warm to the touch. Also swelling on L side of chest. Taking nsaid ATC but pain and swelling has persisted - pressure radiates to L scapula.
33 2021-01-11 injection site swelling, injection site bruising Bruising at site of injection, swelling, numbness in vaccinated arm and tingles.
33 2021-01-11 injection site pain Chills, aching body, sweating, nausea, upset stomach/vomiting, dizziness, loud static ringing in ear... Read more
Chills, aching body, sweating, nausea, upset stomach/vomiting, dizziness, loud static ringing in ears while dizzy/vomiting, injection site soreness. Vomiting subsided but other side effects remain in the afternoon the day after vaccination.
33 2021-01-11 injection site swelling, injection site redness, injection site warmth, injection site pain Injection site reaction that was 3 inches by 3 inches, the site was red, warm to the touch, swollen... Read more
Injection site reaction that was 3 inches by 3 inches, the site was red, warm to the touch, swollen and sore. This is the same reaction that she had during the first dose and reported it when receiving her second dose. She stated that the first time it lasted 6 days.
33 2021-01-11 injection site redness, injection site swelling, skin reaction Local reaction to vaccine. Red/swollen area extending around injection site.
33 2021-01-11 vaccination site pain Local site pain immediately; headache; chills; fatigue; general body aches; BNT162B2 , 17Dec2020 Dos... Read more
Local site pain immediately; headache; chills; fatigue; general body aches; BNT162B2 , 17Dec2020 Dose number 1, 05Jan2020 Dose number 2; Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes/Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable nurse. This is the mother report. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El0140), intramuscular on 17Dec2020 18:30 (dose number 1, right arm) and on 05Jan2021 18:30 (dose number 2, right arm) at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified prenatal drug, sertraline hydrochloride (ZOLOFT), and acetylcarnitine hydrochloride (NEUROTIN). The patient was pregnant at the time of vaccination. No other vaccines in four weeks was taken. Patient has no COVID-19 prior vaccination. Patient was not tested for COVID-19 post vaccination. The patient experienced Local site pain immediately, headache, chills, fatigue and general body aches next day on 06Jan2021. 09:00. No treatment was given. Event outcome was recovering. The reporter assessed the events as non-serious.
33 2021-01-11 injection site pain Patient describes pain at the injection site, fever, chills, headache, neck pain body aches
33 2021-01-11 injection site pain Patient reports pain at the injection site, then developed chills and fever, body aches, muscle ache... Read more
Patient reports pain at the injection site, then developed chills and fever, body aches, muscle aches. Also reports headache and neck pain.
33 2021-01-11 hives, rash Pt. states that she woke up at 2 am on 1/12/21 with bilateral hand rash/hives and periorbital swelli... Read more
Pt. states that she woke up at 2 am on 1/12/21 with bilateral hand rash/hives and periorbital swelling bilaterally. Pt. states that she used eye drops for eye and advil.
33 2021-01-11 injection site redness, injection site nodule Sore arm noted on vaccine day 0 and 1 Day 7 I developed a knot at injection site with associated red... Read more
Sore arm noted on vaccine day 0 and 1 Day 7 I developed a knot at injection site with associated redness at injection site. Area of redness was oval shaped about 2 inches in length and 1" wide. No treatment was used. Area cleared within 2 days.
33 2021-01-11 vaccination site rash, hives, rash rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back... Read more
rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 22Dec2020 14:00 at a single dose on Arm Left for COVID-19 immunization. Medical history included none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 23Dec2020 21:00, the patient experienced Rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear. Treatment was received for the adverse event which included Benadryl 50mg. The outcome of the events at the time of last observation was recovered/resolved on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered as non-serious. Information on the lot/batch number has been requested.
33 2021-01-11 hives she was a lactating; she was a lactating; Have some side effects last night from Covid Vaccine, got ... Read more
she was a lactating; she was a lactating; Have some side effects last night from Covid Vaccine, got hives right above my breast; she has really bad Asthma/because of that she has "shortness of breath"; Felt like itchy like tingling on my lip; Felt like itchy like tingling on my lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (lot#: EK5730, expiration date: 31Mar2021), via an unspecified route of administration at arm left, on 02Jan2021 04:00, at single dose, for COVID-19 immunization, and salbutamol (ALBUTEROL) via an unspecified route of administration, from an unspecified date, at unknown dose, for asthma. Medical history included ongoing asthma, and ongoing very unslept person, and she was a lactating for she has a baby about year like 13 months ago (2019) so she is still producing milk. Concomitant medication not provided. The patient thought she has some side effects last night from her Covid Vaccine, so she got it yesterday around 4 O'clock and around 10, 10:30 she got hives on her chest, right above her breast, and about an hour after she got the vaccine, she thought it was just her asthma, so she has really bad Asthma, her Asthma kept like, she kept Asthma and because of that she has "shortness of breath" (not clarified), so she was just taking her Inhaler (unspecified medication) but then like last night wherever after that her "bedtime" (not clarified) she got hives on her chest and it felt like itchy like tingling on her lip, she was very unslept person so she just took some Benadryl (treatment) today she woke up fine, she feel fine but she was just thinking it would be okay to take her second dosage (Covid vaccine). When probed if visited to any physician office/ emergency Room for the treatment, consumer stated she just at home, she just took Benadryl. The action taken in response to the events for salbutamol was unknown. The outcome of the events was recovered.
33 2021-01-11 vaccination site redness, vaccination site pain swollen lymph node a couple of days later/swollen lymph node a couple of days later. Which is still ... Read more
swollen lymph node a couple of days later/swollen lymph node a couple of days later. Which is still a little swollen but improving; pain at injection site/painfulness at the injection site; shoulder became very red/painfulness at injection site and redness/ was a defined red mark where the injections was; This is a spontaneous report from a contactable nurse. A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231, expiry date: 30Apr2021), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history included immunosuppression. Concomitant medication included ongoing vedolizumab (ENTYVIO) for immunosuppresion. The patient got a couple of the side effects listed. She developed painfulness at the injection site, and it was red a couple of days. She is wondering if she needs to be worried about getting the second one. It was pretty painful that night. It was pretty painful for the next day. If someone barely brushed up against it, it was very painful. Two days later, her husband noticed her shoulder was very red. And then she realized there was a defined red mark where the injections was. The pain is fine now. She didn't get a rash or have trouble breathing. She did have a swollen lymph node a couple of days later. Which is still a little swollen but improving. She does take an immunosuppressant. The outcome of the events pain at injection site and shoulder became very red/painfulness at injection site and redness/ was a defined red mark where the injections was recovered, while recovering for the event swollen lymph node a couple of days later was recovering.
33 2021-01-12 hives 01/11/2021 at 5pm started with diarrhea, chills, body aches. 01/12/2021 06:00pm facial swelling, l... Read more
01/11/2021 at 5pm started with diarrhea, chills, body aches. 01/12/2021 06:00pm facial swelling, lip swelling, hives. Started Benadryl at home on 01/12/2020. Seen by walk in PMD office 01/13/2021. MD prescribe, 60mg prednisone and to continue Benadryl, 50mg as needed.
33 2021-01-12 rash macular Flush face, blotchy skin, high blood pressure, rapid pulse, tingly fingers. Given 50mg Benadryl
33 2021-01-12 redness, rash macular Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing st... Read more
Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies. Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water. Called 911. After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same) Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
33 2021-01-12 injection site pruritus, injection site swelling, rash, injection site redness, injection site pain Received 2nd dose Sunday 3rd. Monday was extremely fatigued with muscle aches, headache, and injecti... Read more
Received 2nd dose Sunday 3rd. Monday was extremely fatigued with muscle aches, headache, and injection site redness, pain, swelling, and itching developed on arm where vaccine was administered. Tuesday 1/05 fatigue improved however rash started to develop in right arm. Took Zyrtec and rash improved. Last reported a new rash developed improved on right and left thighs that is painful. Medications taken this time were Benadryl.
33 2021-01-12 itchy skin Received the 1st dose of COVID vaccine, felt well when she left, but developed a lot of fatigue and ... Read more
Received the 1st dose of COVID vaccine, felt well when she left, but developed a lot of fatigue and was in bed by 7 pm, very unusual for her. She woke up next day and had some swelling on her forehead and generalized itching. She took an Allegra and facial swelling resolved. No perioral swelling or lesions. No erythema. Then had 3 episodes of vomiting. Still feels nauseated. She contacted her PCP, who advised being seen. Pt uses Singulair at night, Allegra or Zyrtec in morning if she is itchy. Pt denies cough, shortness of breath, abdominal pain, diarrhea, skin irritation. For Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type- ondansetron ODT (ZOFRAN ODT) 4 mg oral tablet,disintegrating; Dissolve 1 tablet on tongue and swallow every eight hours as needed for nausea/vomiting. Dispense: 15 tablet; Refill: 0. Pt appears well. No facial swelling. History consistent with allergic reaction to COVID vaccine. No evidence of anaphylaxis.Pt to self-report to Occ Health and agency. I also left message at Occ Health. Zofran ordered prn nausea. Pt has an Epipen. She lives with her husband, who can also monitor her. To ED if she develops fwelling, shortness of breath, cough, wheezing, persistent vomiting, or otherwise worsens.
33 2021-01-12 redness, injection site mass Redness and lump on injection site
33 2021-01-12 redness, itchy skin Systemic: itching, swelling, pain, redness of left hand (received vaccine in left arm); symptoms las... Read more
Systemic: itching, swelling, pain, redness of left hand (received vaccine in left arm); symptoms lasted 0 days
33 2021-01-12 redness Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She sai... Read more
Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She said she got dizzy, extremely hot and felt like she was "swaying" She said she also got what she described as "menstrual like cramps" that radiated all around her abdomen and back. She was under observation as advised per Pfizer protocol. An associate of the Pt noticed she passed out for a second she then turned beet red from her head to her neck as we could see. The associate yelled for us to grab a BENADRYL. They hooked her up to a BP machine and she did present with a spike in BP. After a few minutes, the redness and symptoms subsided. She was observed by the medical staff at the facility.
33 2021-01-13 hives Allergic reaction in the form of hives on the underside of both arms, near the armpit.
33 2021-01-13 vaccination site pain Chills; light headed; body aches; headache; fatigue; injection site pain; This is a spontaneous repo... Read more
Chills; light headed; body aches; headache; fatigue; injection site pain; This is a spontaneous report from a contactable other-HCP. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899), via an unspecified route of administration on 29Dec2020 11:15 at single dose for covid-19 immunisation. Medical history was none. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC). The patient experienced Chills, light headed, body aches, headache, fatigue, injection site pain on 30Dec2020 02:00. All events were non serious. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolved.
33 2021-01-13 injection site pain First day: Sore arm at injection site Second Day: Whole Body Aches, Fatigue and later in the evening... Read more
First day: Sore arm at injection site Second Day: Whole Body Aches, Fatigue and later in the evening sore right underarm(OTC's used and alleviated symptoms) Third Day: Swollen underarm on the Right side that is painful to the touch(OTC's used, Hot/Cold compresses with little relief)
33 2021-01-13 hives about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided w... Read more
about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided wheezes. I self treated with albuterol (2 puffs) inhaler that I have on hand in case of environmental allergy triggers (I rarely have to use it- last use 3 years ago). The wheezing resolved and chest pain improved but the hoarseness remained. Over the next 2-3 hours I developed headache, malaise, mild dizziness, arthralgia, myalgia, and eventually fevers and chills (by 13 hours after vaccine administration). When fever reached 101 I self treated with naproxen 250mg. I slept for 4 hours and awoke diaphoretic, but the fever had resolved and I felt much better. However, I developed urticaria that started on my flexor surfaces of the elbows, hips, and knees, and spread to my adbomen, thighs, and face, with swelling about my right eye. I self treated with 25mg benadryl and itching and urticaria improved to the point that I was able to sleep. When I awoke the next morning my symptoms had largely resolved with the exception of mild headache, body aches, hoarseness, slight chest tightness, and mild residual swelling of the right eyelid.
33 2021-01-13 vaccination site pain feeling fatigue; she has swollen lymph nodes in the right axillary area and the right breast; swolle... Read more
feeling fatigue; she has swollen lymph nodes in the right axillary area and the right breast; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; had a slightly elevated Hemoglobin; soreness in the left arm where she received injection; This is a spontaneous report from a contactable consumer. A 33-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231) in the left arm via an unspecified route of administration on 29Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included supraventricular tachycardia from 2015 (It is under control currently. She was diagnosed in 2015 and she had ablation right away). The patient got the flu vaccine which was required by her workplace was Oct2020. She had flu symptoms, sore throat, and a little headache. Concomitant medication included colecalciferol (VITAMIN D) from 2020 and ongoing. The main side effects was soreness in the left arm where she received injection for one to two days. She couldn't lift her arm. Soreness in the left arm started around 17:00 on 29Dec2020. The patient had a physical on Monday (04Jan2021) and everything was perfectly fine. When she did all the blood work and everything was fine. She had a CBC count on Monday (04Jan2021) and the white blood count was normal. She had a slightly elevated Hemoglobin. All other test like calcium and blood sugar were all normal. Swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore. Then on 06Jan2021 when she looked in the mirror she flexed her arm and saw a line around the breast and it was a little swollen. She got the injection in the left arm. She clarified that she has swollen lymph nodes in the right axillary area and the right breast. There is no swelling on the left. The patient stated today (08Jan2021) the swollen lymph nodes and breast is worse. She is feeling fatigue and can't palpate nodes in breast or axillary area. When she lifts her arm there is a line on the right breast. The outcome of Swollen lymph nodes was not recovered; of other events was unknown.
33 2021-01-13 skin swelling, skin laceration mild right sided tear through swelling where dermal filler has been used; mild right sided tear thro... Read more
mild right sided tear through swelling where dermal filler has been used; mild right sided tear through swelling where dermal filler has been used; received BNT162B2; first dose on 18Dec2020 15:00 and second dose on 06Jan2021 20:45; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899 and expiry date unknown) via unspecified route of administration on 06Jan2021 20:45 at left arm for Covid-19 immunization in a workplace clinic. Medical history included covid prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medications was none. Historical vaccine included first dose of BNT162B2 (lot number EJ1685) on 18Dec2020 15:00 at right arm for Covid-19 immunization. On 08Jan2021 18:30, the patient experienced mild right sided tear through swelling where dermal filler has been used. The patient was not covid tested post vaccination. The outcome of the events mild right sided tear through swelling where dermal filler has been used was recovering. The reporter considered the event non-serious; which did not result in death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect.
33 2021-01-13 skin irritation tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache;... Read more
tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache; blurred vision at long distances; lightheadedness; occasional off balance; diarrhea; low grade fever; body aches; This is a spontaneous report from a contactable Nurse. This 33-year-old female Nurse (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), intramuscular on 05Jan2021 06:45 AM at single dose on left arm for COVID-19 immunisation. Medical history included hypertension (HTN), depression and anxiety. No known allergies. Concomitant medication included quetiapine fumarate (SEROQUEL), metoprolol, hydrochlorothiazide, lithium, alprazolam (XANAX), lamotrigine (LAMICTAL), folic acid / iron (PRENATAL), multivitamins [vitamins nos] (MULTIVITAMINS), melatonin, ibuprofen, paracetamol (TYLENOL). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: Eh9899), intramuscular on 15Dec2020 07:30 AM on left arm for COVID-19 immunisation. The patient extreme headache with blurred vision at long distances (blurred vision resolved after 24 hours) lightheaded ness/occasional off balance, diarrhea, low grade fever, body aches, tactile overstimulation (having clothing or a blanket hurt and irritated her skin) on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the event blurred vision at long distances was recovered in Jan2021. The outcome of other event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
33 2021-01-14 injection site pain, itchy skin, redness 12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a f... Read more
12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a felt a tickle in my throat, swallowed and felt like I swallowed the wrong way and was coughing to the point of feeling like I was going to vomit. Per everyone around I was bright red and I looked weird. The ER nurse said my heart rate was 125 and my systolic BP was elevated at 130s (normally in the 110s). After sitting for 45 mins heart rate was back to 60s. Still felt like I was in a fog but felt ok. Once I walked to my car I felt alot of nausea again and was on and off the rest of the day. In the middle of the night I woke up short of breath laying on my back had to lay on my side. 12/21. I was moving pavers and got short of breath. Checked my heart rate and it was 100. O2 sat was 99%. If I sat and didn't move I was fine as soon as I started moving it started again. Also felt nauseating all day. I was having a hard time concentrating and my husband was getting frustrated that I wasn't understanding what he was saying. My left arm hurt really bad all day 12/22 By the afternoon felt more normal except my arm still hurting really bad. 12/26 was shoveling dirty and suddenly my arm where I got the injection started hurts and I got very nauseated again. On 12/29 the cdc called me because I did the vsafe program. They were wondering if I was actually going to get the second vaccination because they said my reaction is a severe reaction. 12/30 my arm started itching had chills and temp right after 1/1 rapid test was negative for covid 1/2 pcr was negative
33 2021-01-14 vaccination site pain Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everyw... Read more
Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everywhere even clothes against my skin hurt/it was all I could do to physically get to bed, which hurt with every step; temp of 99.7; malaise; profound sleepiness; Arm pain at injection site; Arm pain at injection site; This is a spontaneous report from a contactable Physician reported for herself. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at Left arm on 08Jan2021 09:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historic vaccine included the first dose of BNT162B2 on 18Dec2020 08:00 AM intramuscular at Left arm for covid-19 immunization. The patient experienced Chills, fatigue, muscle aches so bad it made her cry, pain everywhere even clothes against her skin hurt, temperature of 99.7, malaise, profound sleepiness, and it was all she could do to physically get to bed, which hurt with every step. Arm pain at injection site for 2 days now, could not sleep on that side, adverse event start date was provided as 08Jan2021 09:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
33 2021-01-14 hives I had experienced body aches, and chills on the day of the vaccine. On Monday following the vaccine ... Read more
I had experienced body aches, and chills on the day of the vaccine. On Monday following the vaccine I had hives all Over my body which were treated with Benadryl. On Tuesday the hives persisted but treated during the day with Benadryl, at about 10:30pm the hives started to show on my face, my lips got swollen, and I felt like a pit in my throat That was stuck. I went to the ED and I was treated with IV Benadryl, IV Pepcid, and IV Solumedrol. I left the ED upon signs of improvement and was given prescriptions for Epi pen and steroids for 4 days.
33 2021-01-14 injection site pain Immediate headache and pressure at base of skull into neck. L Arm stiffness/weakness/tenderness that... Read more
Immediate headache and pressure at base of skull into neck. L Arm stiffness/weakness/tenderness that goes down into my hand and left side neck tightness/stiffness (muscular), upper back & B/L shoulder aching and muscular stiffness. Feels almost like a dull ?electrical shock? feeling across my upper back and down my left arm. Joint pain on the L side of my body-elbow, hip and knee. All symptoms continue into the night on day 2 after the vaccine (past 24 hrs after receiving).
33 2021-01-14 rash, rash with redness Rash with redness and scaling on torso 48 hours following Pfizer-BioNTech COVID-19 vaccine 0.3 mL in... Read more
Rash with redness and scaling on torso 48 hours following Pfizer-BioNTech COVID-19 vaccine 0.3 mL in right deltoid. No vesicles or pustules and no other features that suggest a erupting case of herpes zoster. Some are flat. There is no perilesional pallor. Provider examined skin. Assuming patient improved since there are no notes of worsening in the chart.
33 2021-01-14 skin warm, rash with redness, rash papular, itchy skin, hives Severe urticaria, papular rash. Full body itchy, warm, red rash. Prescribed Tagamet,Benadryl and Pre... Read more
Severe urticaria, papular rash. Full body itchy, warm, red rash. Prescribed Tagamet,Benadryl and Prednisone 2 days after vaccination. Rash has only been getting worse each day.
33 2021-01-14 hives Vaccinated 1/11/2021 at 11:30 AM, at approx. 10 PM experienced moderate pain scale diffuse body ache... Read more
Vaccinated 1/11/2021 at 11:30 AM, at approx. 10 PM experienced moderate pain scale diffuse body aches. This lasted a few hours, improved with advil. After body aches subsided at around 2 AM 1/12/2021 experienced mild allergic reaction of hives and lip swelling. This allergic reaction subsided by morning 1/12 with benadryl. I have never had any side effects or allergic reaction to a vaccine. I did experience similar mild allergic reaction with antibiotic bactrim, a sulfa based medication.
33 2021-01-14 injection site pain Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a fe... Read more
Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a few hours: increased fatigue, mild ?brain fog? with some word finding difficulty, mild pressure behind eyes 3am, ~16 hours post: mild to moderate body aches, low grade fever 98-99 degrees 8am, ~21 hours post: mild body aches, back to normal temp, continued fatigue, TERRIBLE headache! 7-8/10 pain for about 10 hours. Throbbing in temples, eye pressure, pressure on top of head, worsened when I would bend over. Did not take any medication, worried it would impact immune response. Drank a lot of water, slept, did some sled massage, and gentle yoga/stretches. By that evening pain level had dropped down to about a 4. Woke up the next morning with 2-3 level pain, was able to go to work without being distracted by pain. Still felt more pressure behind eyes and top of head when I bent over. Next day all symptoms resolved, except very minor tenderness at injection site only when palpated.
33 2021-01-14 hives had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; t... Read more
had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; tachycardia; This is a spontaneous report from a contactable other HCP (Patient). A 33-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3248), via an unspecified route of administration at right arm on 07Jan2021 16:15 at single dose for covid-19 immunization. Vaccine was administered at hospital. Known allergies included cyclobenzaprine and dairy latex. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 10 mg, gabapentin 300 mg, venlafaxine 150 mg. No other vaccine in four weeks. Three minutes after vaccination the patient had a metallic taste, turned to swollen tongue, hives around chest and neck, difficult to breathe, and tachycardia on 07Jan2021 16:18. The events resulted in Emergency room/department or urgent care. Treatment received included Epinephrine, methylprednisolone sodium succinate (SOLU-ME dork) and famotidine (PEPCID) also diphenhydramine HCl (BENADRYL). The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events metallic taste, swollen tongue, hives, difficulty breathing and tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-01-15 hives, itchy skin ABOUT 20 MINUTES AFTER INJECTION BEGAN TO FEEL ITCHING ALL OVER BODY, SHORTNESS OF BREATH, FLUSHING,... Read more
ABOUT 20 MINUTES AFTER INJECTION BEGAN TO FEEL ITCHING ALL OVER BODY, SHORTNESS OF BREATH, FLUSHING, HIVES AND NAUSEA - TAKEN TO ER FOR OBSERVATION AND ADMINISTERED DIPHENEHYDRAMINE - RECOVERED AND DISCHARGED
33 2021-01-15 redness, itchy skin, hardening Pfizer-BioNTech COVID-19 Vaccine EUA Localized inflammation, erythema, induration, swelling, pain, i... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Localized inflammation, erythema, induration, swelling, pain, itching. Began on post-vaccine day one and continues into post-vaccine day two with less pain and slight reduction in swelling. Iced it on day one with some relief of swelling and pain.
33 2021-01-15 hives dry itchy throat starting within 20 minutes. waited until approx 330 to take a benadryl as it was ha... Read more
dry itchy throat starting within 20 minutes. waited until approx 330 to take a benadryl as it was harder to swallow, an hour and a half later hives began to show at approx 530 went to urgent care. was prescribed steroids. took benadryl over night to keep from iching and started steroids this morning. no more hives have showed since going to urgent care.
33 2021-01-16 injection site pain Low-grade fever, body aches, chills and injection site soreness - symptoms began 8-10 hours after va... Read more
Low-grade fever, body aches, chills and injection site soreness - symptoms began 8-10 hours after vaccine was administered and lasted for about 18 hours
33 2021-01-17 injection site pain Arm soreness at vaccine site that night; moderate pain. Was exposed to COVID 20 hours after 1st vacc... Read more
Arm soreness at vaccine site that night; moderate pain. Was exposed to COVID 20 hours after 1st vaccine. Developed symptoms of COVID that Monday - five days after vaccine. Tested COVID positive that same day. Started with headache, then I had a fever over 101. Chills - bad chills. Lost my taste and smell a couple days after that and that lasted a long time (about three days to get smell back and 10 days for taste). Just took Tylenol for the fever and headache. Also got leg pain - muscle type aches - painful - started on the 29th of December. Leg pain lingered and the pain went away by about the 7th of January. Took Tylenol as needed for that pain.
33 2021-01-17 hives, rash, itchy skin Ear swelling, hives on face and neck, facial tingling, rash on cheeks, tingling and itchiness in thr... Read more
Ear swelling, hives on face and neck, facial tingling, rash on cheeks, tingling and itchiness in throat and face - 45-60 minutes after injection. Waiting for 30 minutes and no adverse effects until leaving facility
33 2021-01-17 injection site pain Fatigue, chills, mild fever, headache, injection site pain, swollen lymph node
33 2021-01-17 hives Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has receive... Read more
Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has received first dose of COVID vaccine made by Phfizer at 3:45. She reports about 10 minutes after the vaccination she started feeling tingling in her lips, throat and prickly sensation on her chest and feeling "off". Felt dizzy, developed small hives on her chest. She was attended to immediately at the vaccine site and our team was called to white code. Pt was sitting on the floor, alert , breathing comfortably. Her BP was 151/84, HR 90, O2 Sats 100%. Her lungs were clear the whole time, no wheezing, no difficulty swallowing or talking. Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably, speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her site the whole time but refused to used it, states she is afraid to use it and wants to hold off or get it in ER if necessary. About 16:30 patient reported her tingling, prickly sensation In her chest is getting worse, developed sensation of lump in her throat, able to swallow and breath without problems, lungs exam clear. Again recommended to give Epipen but patient again refused as she feels very anxious about getting new medicine. She was able to speak full sentences and breathing well, O2 Sats 100% the whole time, she repetitively refused EpiPen. EMS called and patient transported to ER, ER notified. Pt left in stable condition.
33 2021-01-17 injection site pain The same night as the vaccine, I developed a fever greater than 101.5 and developed bad chills throu... Read more
The same night as the vaccine, I developed a fever greater than 101.5 and developed bad chills throughout entire night. Could not sleep because of chills. Next morning, developed severe legs pains and deep muscle pain - both legs - both calves, both sides. Resulted in me having to miss that day of work. I called my Dr's office and they advised to go to ER for severe leg pain. I didn't because I had a pharmacist that I work with who had advised me that I could wait. Similar symptoms to when I got COVID (on Dec 28th). Did have the same moderate arm pain in location of vaccine. Fever stayed above 100 for 48 hours. And the chills went away after 12 hours. Around the clock Tylenol that stated when I got the vaccine - 1000 mg every six hours scheduled. Fever resolved after 2 days. Chills after 12 hours. Leg pain from severe on 15th - to moderate pain next day and on 18th the pain is more mild. Pain in legs haven't resolved entirely but much better.
33 2021-01-17 rash, itchy rash, rash with redness allergic reaction; large red itchy rash on her neck / chest area; trembling; This is a spontaneous r... Read more
allergic reaction; large red itchy rash on her neck / chest area; trembling; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration (lot number: EL1283) in the arm right on 07Jan2021 09:00; at single doses for COVID-19 immunization. Medical history included known allergies: latex. Concomitant medications included magnesium oxide (MAG OXIDE) at 200 mg, daily (every day) and cetirizine hydrochloride (ZYRTEC) at 10 mg, daily (every day); and toprolol at 25 mg, every day (pending clarification for the drug). The patient previously received first dose of BNT162B2 on 17Dec2020 (lot number: EK5730) for COVID-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination; and has not been tested for COVID-19 since vaccination. Within the 15-minute observation period on 07Jan2021, the patient developed a large red itchy rash on her neck and chest area; she stated she felt fine but was observed trembling. She was transported to ED (emergency department, 5 min transport). She was treated with diphenhydramine hydrochloride (BENADRYL) at 25mg IV X1 (intravenous), and methylprednisolone (SOLUMEDROL) at 60mg IV X1 and famotidine 20mg IV X 1. Patient diagnosis was allergic reaction on 07Jan2021. Patient improved after treatment and was discharged (after being in Emergency room/department or urgent care) as she was observed from 09:11 until 10:33. Final outcome of the events was all recovered on unspecified date.; Sender's Comments: Based on the time association, the allergic reaction, rash erythematous and trembling are possibly related to suspect BNT62B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-01-17 injection site pain, injection site swelling minor side effect: night of injection had vivid dream, and 2nd night after injection had another viv... Read more
minor side effect: night of injection had vivid dream, and 2nd night after injection had another vivid dream when I do not typically have dreams minor side effect of some chills 13 hours after injection that slight worsened, persisting until 36 hours after injection (resolved 1.5 days after injection) moderate pain at site of injection, onset 5 hours after injection and lasting until 2.5 days after injection
33 2021-01-18 injection site pruritus, injection site warmth, injection site reaction, injection site redness Localized rxn at injection site - site red warm and itchy
33 2021-01-18 injection site redness, itchy skin, injection site warmth, injection site pruritus Redness, increased warmth, itchiness on Lt deltoid where IM injection was placed. Scratch throat, i... Read more
Redness, increased warmth, itchiness on Lt deltoid where IM injection was placed. Scratch throat, itchiness on bilateral arms, torso. Symptoms started 10 days after initial COVID 19 Pfizer 1st dose injection. No resolution yet.
33 2021-01-18 redness, rash Swollen cheecks, red face and raised bumps on both right and left arm
33 2021-01-19 injection site tingling, injection site pain 1. mild burning at the site when vaccine administered, 4 seconds. tingling on side of body where inj... Read more
1. mild burning at the site when vaccine administered, 4 seconds. tingling on side of body where injection was given, noted at 4:30 pm and was on and off throughout night. 2. Day after vaccine with "lazy feeling" on the side of vaccine. Full ROM, all extremities moving equally, no gross motor deficit noted
33 2021-01-19 injection site pain COVID-19 vaccine given high on the arm, outside of true deltoid site. Patient noted immediate signif... Read more
COVID-19 vaccine given high on the arm, outside of true deltoid site. Patient noted immediate significant pain at the injection site. Ibuprofen helped. Patient contacted her employee health staff and her PCP related to concerns for risk for possible should joint damage and questions about efficacy if the vaccine was placed outside of the deltoid. Pt was able to supply pictures for her PCP to review. At this time, there is no further information on if the patient had any ongoing pain. However, the patient did not re-contact her PCP which is reassuring.
33 2021-01-19 rash Low grade temp 100.5, facial rash, swollen lymph nodes, fatigue, headache that lasted 6 days
33 2021-01-19 rash Rash temp of 101; Rash temp of 101; body aches; This is a spontaneous report from a contactable othe... Read more
Rash temp of 101; Rash temp of 101; body aches; This is a spontaneous report from a contactable other health professional. This report involves a 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 09Jan2021 10:45 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown dose for covid-19 immunisation. On 10Jan2021, the patient experienced rash, temp of 101, body aches with outcome of recovering. The vaccine was administered at Hospital Facility. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Information on the Lot/Batch number has been requested.
33 2021-01-20 injection site pain Mild to severe arm pain from injection site to elbow. It has gotten better but is still painful to t... Read more
Mild to severe arm pain from injection site to elbow. It has gotten better but is still painful to the touch. I had a headache at 12am after the injection until 01/21/21 at 7am.
33 2021-01-20 injection site swelling Patient experience chills; shivering and injection site swelling. This lasted 3 hours.
33 2021-01-20 injection site warmth, injection site pain, injection site mass, injection site redness, injection site discomfort Redness around injection site, raised bump that is warm to touch and tender, shoulder pain down to e... Read more
Redness around injection site, raised bump that is warm to touch and tender, shoulder pain down to elbow. Reported to Employer at 4:30pm 1/20/21. Employee health recommended an ice pack and ibuprofen for discomfort. Instruction to present to Urgent Care should symptoms worsen.
33 2021-01-20 vaccination site pain Sore injection site; sore muscles; joint aches; Headache; Sore injection site, sore muscles, joint a... Read more
Sore injection site; sore muscles; joint aches; Headache; Sore injection site, sore muscles, joint aches, headache, vomiting; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 33-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm, single dose for COVID-19 immunization on 09Jan2021, 12:45 PM, at 33-year-old. Medical history included: Crohn's, seasonal allergy. Known allergies reported as: tetracycline. The patient did not have COVID prior vaccination. Concomitant medication in two weeks included: budesonide; spironolactone; diphenhydramine hydrochloride (BENADRYL). No other vaccine received in four weeks. The patient had sore injection site, sore muscles, joint aches, headache, vomiting; all on 09Jan2021, 08:00 AM. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. Information on the lot/batch number has been requested.
33 2021-01-20 injection site pain Soreness in arm of injection, extremely swollen and sore lymph node under right arm, body aches, ext... Read more
Soreness in arm of injection, extremely swollen and sore lymph node under right arm, body aches, extreme fatigue
33 2021-01-20 vaccination site swelling, vaccination site itchiness, vaccination site redness, hives, rash broke out in rash/hives all over; broke out in rash/hives all over; mild tongue swelling; sob throat... Read more
broke out in rash/hives all over; broke out in rash/hives all over; mild tongue swelling; sob throat felt sore and swollen; sob throat felt sore and swollen; swelling at injection site; redness at injection site; itching at injection site; feverish; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number=Ej1685, via an unspecified route of administration on left arm from 07Jan2021 11:00 to 07Jan2021 11:00 at SINGLE DOSE (dose 2) for COVID-19 immunisation. The patient as no known allergies, no other medical history, and no allergies to medications, food, or other products. Historical vaccine includes first dose of BNT162B2 on 18Dec2020, time=12:45 PM, vaccine location=Left arm, lot number=Eh9899. The patient's concomitant medications were not reported. On 08Jan2021 05:00 AM, the patient experienced post vaccine swelling, redness, itching at injection site and feverish. On 13Jan2021, the patient broke out in rash/hives all over with mild tongue swelling and sob throat felt sore and swollen for a short time. The patient went to physician and received steroid injection and Benadryl. The outcome of the events was recovering.
33 2021-01-20 rash, hives few hives/rash; few hives/rash; This is a spontaneous report from a contactable healthcare professio... Read more
few hives/rash; few hives/rash; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration in the left arm on 11Jan2021 at 15:00 at a single dose in the hospital for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of report. The patient experienced few hives/rash on 11Jan2021 at 18:00, about 2 hours after getting the vaccine. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. Outcome of the events was unknown.
33 2021-01-21 hives Hives on face, back of neck, top of back, orbital swelling left and right eye
33 2021-01-21 rash, injection site pain Severe right axillary adenopathy (same as inj site arm) within 48 hrs of injection 3" diameter painf... Read more
Severe right axillary adenopathy (same as inj site arm) within 48 hrs of injection 3" diameter painful (7/10) initially causing moderately severe pain that felt muscular while expanding chest or inhaling. Fever up to 102.5F, lethargy, muscle pain, dyspnea, nausea, rash (look like hives)
33 2021-01-22 injection site pain, injection site redness, injection site pruritus, injection site swelling, injection site discomfort Woke up about 2 am rigoring, with terrible pain and itching at injection site and awful body aches. ... Read more
Woke up about 2 am rigoring, with terrible pain and itching at injection site and awful body aches. I took 650 mg Tylenol, fell back asleep, woke up at 330 am sweating and less achy. Awoke again at 7 am with terrible headache, nausea and upset stomach. Injection site swollen, reddened and painful to touch; took another 650 mg of Tylenol without much relief. Entire body was extremely sensitive to the slightest bit of touch or pressure. Had a hazy feeling in my head, felt mildly dizzy for hours. Around 230 pm on 1/19/21 I began sweating profusely for about 15 minutes and when that ceased I felt almost back to normal immediately. By the following day I was feeling 100% OK other than injection site discomfort. Today, 1/23, is the first day since receiving my second dose that my arm Only slightly hurts and itches.
33 2021-01-22 injection site bruising, injection site pain soreness and bruising around injection site, headache, lethargy
33 2021-01-23 injection site pruritus, injection site swelling, injection site redness, injection site pain Pain, swelling, redness and itching at the injection site approximately 24 hours following administr... Read more
Pain, swelling, redness and itching at the injection site approximately 24 hours following administration.
33 2021-01-23 skin warm Patient was dizzy, lightheadedness, flushed, warm, and nauseated. This occurred about 15 to 20 minut... Read more
Patient was dizzy, lightheadedness, flushed, warm, and nauseated. This occurred about 15 to 20 minutes after receiving the vaccination.
33 2021-01-24 blister After vaccination - I was noticing eczema flare up - but not bad; and then 27th, I got blisters on ... Read more
After vaccination - I was noticing eczema flare up - but not bad; and then 27th, I got blisters on left cheek likes pins and needles poking my face; next day the blisters popped and created crater on my skin and area was getting bigger and it was oozing and I felt that stinging poking on that affected area. Next day after that, I went to my dermatologist for a consultation and he said it was Herpes Simplex. Along with that, 2 days after the blisters started appearing on my face, before I went to my dr's office - was having 101. fever, chills, body aches , and severe cough with vomiting and not able and so I got tested the day I went to my Dr. and it was a negative COVID test. Treatment: Antiviral medication for one week; Topical ointment: Bacteralban ointment; I still have the face color with the Herpes was.
33 2021-01-24 injection site pain Febrile starting at 2am (13 hours post vaccine) with full body chills. Pain at injection site lastin... Read more
Febrile starting at 2am (13 hours post vaccine) with full body chills. Pain at injection site lasting about 36 hours post injection. Full body aches, weakness and over all fatigue starting 12 hours post vaccination until 30 hours post vaccination. Symptoms improved some with naps and two tablets of Aleve. Swollen lymph in right armpit which developed about 24 hours post vaccination and finally disappeared 4 days after vaccination.
33 2021-01-24 hives Hives on chest for approximately 45min
33 2021-01-24 injection site pain Injection site pain, headache, muscle aches, fatigue, chills and nausea
33 2021-01-24 vaccination site pain Myalgias; Arthralgias; Pain at injection site; Headache; This is a spontaneous report from a contact... Read more
Myalgias; Arthralgias; Pain at injection site; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received BNT162B2 (lot number: EL0140), via an unspecified route of administration in left arm on 29Dec2020 08:00 at single dose for COVID-19 immunization. Medical history included celiacs disease, dermatitis herpetiformis, melanoma in situ, known allergies: Gluten, and COVID prior vaccination. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient experienced myalgias, arthralgias, headache, and pain at injection site on 30Dec2020 00:00. No treatment was received for these events. Outcome of the events was not resolved.
33 2021-01-24 injection site pain Pain at injection site, Dizziness, fever, chills, all over muscle pain, Headache, left armpit lymph ... Read more
Pain at injection site, Dizziness, fever, chills, all over muscle pain, Headache, left armpit lymph node swelling and soreness
33 2021-01-24 redness passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode... Read more
passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode of hypertension; feeling hot; was "swaying"; had menstrual like cramps that radiated from her abdomen to her entire body; had menstrual like cramps that radiated from her abdomen to her entire body; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at the first single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Within in minutes of receiving the vaccine on 13Jan2021, the patient reported a fruity taste in her mouth, turned "Beet red" on her neck/face, and passed out briefly. When she regained consciousness, she was given Benadryl, and also was reported to have an episode of hypertension. She reported feeling hot and was "swaying" and had menstrual like cramps that radiated from her abdomen to her entire body. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the event "passed out briefly". The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug, similar event, different patient
33 2021-01-25 injection site pain, hives, injection site swelling Fever, Chills, Fatigue, swelling at injection site with pain, Hives
33 2021-01-25 rash RASH ON FACE AND HANDS
33 2021-01-25 injection site reaction, injection site pain Site: Pain at Injection Site-Medium, Systemic: Other- injection site muscle twitching which was grea... Read more
Site: Pain at Injection Site-Medium, Systemic: Other- injection site muscle twitching which was greatly lessened with arm motion/neck massage
33 2021-01-25 injection site swelling, injection site pruritus Starting 1/23/21 - pain and swelling in armpit that has continued (including today) - very itchy on... Read more
Starting 1/23/21 - pain and swelling in armpit that has continued (including today) - very itchy on 1/24 and became swollen again at injection site (1+ week after shot)
33 2021-01-25 injection site pain fever, chills, body aches to right side of body, Tenderness under arm, Right buttock soreness, Lum... Read more
fever, chills, body aches to right side of body, Tenderness under arm, Right buttock soreness, Lump near right side of neck, next to clavicle. Ibuprofen for body aches taken sunday , Monday. Today Tuesday 1-26-21 continues with soreness to right underarm, injection site and lump on neck.
33 2021-01-25 hives started at my chin and my jaw line and to my cheek bones and had hives, face started to swell, lips,... Read more
started at my chin and my jaw line and to my cheek bones and had hives, face started to swell, lips, and eyelids, had to take 2 Benadryl.
33 2021-01-26 injection site redness, injection site pain, injection site pruritus, injection site warmth 01/19/21 10 PM: Redness, warmth, tenderness, itchiness, swelling to injection site, affected area un... Read more
01/19/21 10 PM: Redness, warmth, tenderness, itchiness, swelling to injection site, affected area under 2 inches in diameter. Took Benedryl 50 mg and Ibuprofen 800 mg. Took Ibuprofen 800 mg about 8 hours later, took Ibuprofen 600 mg about 8 hours later, took Ibuprofen 600 mg and benedryl 50 mg, took ibuprofen 400 mg about 8 hours later, took Benedryl 25 mg at bedtime. 01/21/21 12AM: Redness fading, swelling almost back to baseline, no tenderness, no itchiness. 01/26/21 10 AM: Itchiness present, dark pink injection site under 2 inches in diameter 01/26/21 8:30 PM - 8 Days post injection: Redness, warmth, itchiness, swelling to injection site, affected area just over 2 inches (2 2/8ths inches) in diameter. Took Benedryl 50 mg and Ibuprofen 800 mg. Center of injection site reading at 100.4°F via iHealth no-touch infrared forehead thermometer. An inch above read 96.9°F, an inch below read 96.9°F, my forehead read 98.4°F all temps within seconds of the previous reading. Took Benedryl 50 mg and Ibuprofen 800 mg.
33 2021-01-26 injection site tingling, injection site numbness Patient reports tingling/numbness in upper left arm at injection site down to left finger tips, like... Read more
Patient reports tingling/numbness in upper left arm at injection site down to left finger tips, likened to "arm being asleep and waking up". Writer performed stroke assessment due to patients reported symptoms. Assessment negative. Assessment of injection site negative. Patient remains A&O x4 (person, place, time, and situation). Patient reports improvement with continued movement with arm. Patient released to self to home after reported symptoms subsided - ~30 minutes from start to finish
33 2021-01-26 itchy skin Symptoms ? EE reports generalized itchiness approximately 1 hour after vaccine. EE reports + HA, bu... Read more
Symptoms ? EE reports generalized itchiness approximately 1 hour after vaccine. EE reports + HA, but reports, ?I had a headache before the vaccine.? EE reports same issue after 1st dose of vaccine. EE reports she notified the monitors at the vaccine site and recommended to take motrin for HA and to call vaccine support for further instructions. Last day of work and shift - ?unknown, not working today per EE Home remedies? - EE educated to take Benadryl or Claritin as indicated in the Medical directive. EE reports, ?I?ll take a Zyrtec.? EE educated to f/u with PCP if symptoms worsening. EE verbalized back understanding and denied further questions. Any improvement? ? N/A Recommendation? EE educated to take Benadryl or Claritin as indicated in the Medical directive. EE reports, ?I?ll take a Zyrtec.? EE educated to take motrin as indicated in the Medical directive. EE educated to f/u with PCP if symptoms worsening. EE verbalized back understanding and denied further questions. EE reports she will fill out report.
33 2021-01-27 redness Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following ... Read more
Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: burning sensation that started in the abdomen that traveled up to her throat within two minutes of receiving the vaccine Lot: EL3247 Time of Administration: 11:55 Time Symptoms Began: ~11:57 _____ Patient alerted observer who took the patient to the medical observation area. I was alerted and responded. Initial Assessment @ _1158_: Patient is Patient is AAO. The employee is sitting up on the sofa. The employee is pink and does not appear to be in distress. She is talking and making conversation. She thinks its just anxiety. I gave her some juice. She was able to drink it without problem. She noted that the sensation was going away. At 11:59-12:00, it was resolved and she returned to observation. Her time to leave the clinic was 12:10. She was going to let me know if any new sx began. Employee was discharged without treatment. The RN was notified for follow up.
33 2021-01-27 itchy skin, rash Rash on both arms and back. Vaccine administered 6:30pm. Waited for 15 minutes to make sure no rea... Read more
Rash on both arms and back. Vaccine administered 6:30pm. Waited for 15 minutes to make sure no reaction presented. Took a shower. Rash occurred on both arms and on back. Very itchy. Took benadryl and rash dissipated. No other symptom occurred after. Never had a reaction to vaccine prior.
33 2021-01-27 injection site pain The patient received the Pfizer vaccine first dose on 12-21-2020 in her left deltoid. She experience... Read more
The patient received the Pfizer vaccine first dose on 12-21-2020 in her left deltoid. She experienced numbness, tingling and weakness of the LUE. Onset was a few hours after the injection. They lasted 2 weeks. She also experienced isolated soreness to the site of injection. No other systemic complaints. Symptoms progressively resolved and she received the second dose on 1-9-21 in the thigh with no complications.
33 2021-01-28 injection site reaction 1ST TIME - INJ 1/6/21 EL0142 (throbbing headache after I left the hospital. It didn't go away until ... Read more
1ST TIME - INJ 1/6/21 EL0142 (throbbing headache after I left the hospital. It didn't go away until I took 2 Exedrin & went to bed. I also had some nausea as well and was fatigued). 2ND VACCINE - INJ 1/29/21 EL324 (much worse - fatigue, muscle pain, extreme nausea, headache, and metallic taste in mouth after 15 min wait passed. i also had an inj site reaction. my right arm was burning and i had a stinging pain)
33 2021-01-28 injection site mass, injection site warmth, injection site redness bump at injection site. turned red and warm. moist heat does not help go down.
33 2021-01-29 rash Rash distal. Vértigo Dolor muscular y articular generalizado Fiebre Gripe Escurrimiento nasal Cefal... Read more
Rash distal. Vértigo Dolor muscular y articular generalizado Fiebre Gripe Escurrimiento nasal Cefalea Dolor abdominal Diarrea Náuseas Disgeusia Fatiga
33 2021-01-29 injection site pain Three hours post injection: mild sore arm around injection site for 24-36 hours; mild fatigue for 72... Read more
Three hours post injection: mild sore arm around injection site for 24-36 hours; mild fatigue for 72 hours minimum; low grade headache for 48 hours; muscle aches into shoulder blade and neck area for 72 hours minimum.
33 2021-01-30 injection site swelling, injection site pain Injection site pain, tiredness, headache, severe aches and pains throughout body joints and muscles,... Read more
Injection site pain, tiredness, headache, severe aches and pains throughout body joints and muscles, chills so bad that I was convulsing, injection site swelling, nausea, feeling sick for more than 2 days, swollen lymph nodes in left arm pit, chest feeling tight and lungs feeling heavy
33 2021-01-30 rash with redness, shingles, rash Small Burning rash on neck 24 hours after injection. Went away after 3 days.
33 2021-01-31 injection site redness Approximately 17 minutes after vaccination to right deltoid, (patient) approached medical assistan... Read more
Approximately 17 minutes after vaccination to right deltoid, (patient) approached medical assistant in observation area reporting difficulty breathing and feeling of throat swelling; verbal and visual evaluation performed promptly by COVID-19 RN in observation area, as exam room was occupied by another patient; patient then escorted to office room adjacent to exam room and placed into sitting position in office chair by COVID-19 RN ; (nurse practitioner) notified as was escorted to office and verbal and clinical evaluation performed by RN after patient placed into seated position; erythematous patch noticed circumscribing injection site during visual inspection; Epinephrine administered via auto-injector to left vastus lateralis at 20min minutes post immunization as patient reported worsening tightness in the throat and chest and increasing difficulty breathing ; EMS personnel, already onsite for other patient, responded and assumed care shortly after administration of epinephrine; patient alert and accompanied by one of her co-workers for transport to Hospital via EMS
33 2021-01-31 injection site pain Injection site pain lasting longer than 24h, limited range of motion, pain radiating to neck and bac... Read more
Injection site pain lasting longer than 24h, limited range of motion, pain radiating to neck and back muscles, pain with movement
33 2021-01-31 itchy skin Received dose #1 at 12:04, at 1228 reported "feeling very itchy" and made a comment "its like if som... Read more
Received dose #1 at 12:04, at 1228 reported "feeling very itchy" and made a comment "its like if someone has a cat in here or something." "My throat is now feeling tight." Rapid Response called and the patient was transported to the ED for further evaluation.
33 2021-01-31 injection site pain, injection site swelling, injection site redness Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
33 2021-02-01 rash, itchy skin 3 days after taking 2nd dose of covid vaccine developed chills, headache, nausea, vomiting, bodyache... Read more
3 days after taking 2nd dose of covid vaccine developed chills, headache, nausea, vomiting, bodyache, joint swelling, rash and itching all over body.
33 2021-02-01 skin warm I received my second dose of Pfizer on 01/11/2021 @6:30pm. I started feeling my whole body aching an... Read more
I received my second dose of Pfizer on 01/11/2021 @6:30pm. I started feeling my whole body aching and my face was flushed @8:00am on 01/12/2021 @6pm I felt really bad I had a fever of 102.5 that would not go down, my body was so weak I was unable to move I couldn't feel my feet only my legs, I was shaking from chills I felt really cold but my body was really hot to the touch and my temp was really high, I felt pressure on the left side of my head like it was going to pop. @ 5am on 01/13/2021 I woke up like nothing ever happened and have been good ever since.
33 2021-02-01 injection site redness, injection site rash, injection site warmth Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21... Read more
Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21) noted quarter-sized red rash at injection site along with fatigue, whole body aches, that later progressed into headache, nausea and overall feeling unwell. That evening experienced chills. The following morning (1/22/21) injection site redness/rash was roughly 3in in diameter and warm to touch. Right front shoulder pain began and still continues 12 days post vaccine administration.
33 2021-02-01 injection site redness Staff reported generalized muscle aches and weakness, along with sleepiness. She noted injection sit... Read more
Staff reported generalized muscle aches and weakness, along with sleepiness. She noted injection site redness. On 1/14/20 at 15:30, her temperature was measured at 100 degrees F. Slightly elevated temp resolved on its own with increased fluids. She rested at home and symptoms resolved.
33 2021-02-01 vaccination site swelling, vaccination site redness, vaccination site pain read around the site and more swollen; fever of 101 or less; chills; injection site pain; Headache; ... Read more
read around the site and more swollen; fever of 101 or less; chills; injection site pain; Headache; body aches; nausea; read around the site and more swollen; administration date 15Jan2021; This is a spontaneous report from a contactable nurse (patient herself). A 33-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), intramuscular in the left arm on 15Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included ulcerative colitis, depression, and incomplete lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included vedolizumab (ENTYVIO), and fluoxetine hydrochloride (PROZAC). The patient previously took first dose of bnt162b2 (lot number: EK9231, expiry date not reported), intramuscular in the right arm on 29Dec2020 at 12:00 PM at single dose for COVID-19 immunisation. The patient verbalized, "The day after the second vaccine I had a fever of 101 or less, chills, injection site pain, headache, body aches especially in my lower back and neck ,and some nausea. I took Tylenol which helped with the fever, but the headache continued that day. On the second to hear from vaccine I continued to have a fever and chills with some body aches but improving. On the second day I noticed the injection site was not only painful but read around the site and more swollen. Currently it is Tuesday and I no longer have a fever but continue to have injection site pain, redness, swelling. I have an appointment to follow up with my doctor for any further recommendations." Clinical outcome of fever was recovered on an unspecified date; for pyrexia, chills, and body aches was resolving; while for the other events was unknown.
33 2021-02-02 injection site tingling, injection site numbness - [ ] Day 1: severe migraine (2-2.5 hours after the shot) - [ ] Day 2: muscle aches, nausea, fatigue... Read more
- [ ] Day 1: severe migraine (2-2.5 hours after the shot) - [ ] Day 2: muscle aches, nausea, fatigue - [ ] Day 3: muscle aches, migraine, serious heartburn, nausea, dizziness, cold sweats, fatigue, loss of breath, abdominal/chest pain (questioned if it was a heart attack) - [ ] Day 4: nausea, cold sweats, fatigue, abdominal pain, mild muscle aches, dry mouth - [ ] Day 5: woke up at 1100. Already very fatigued and cold sweats. Dizzy. Napped from 1415-1545. Dry mouth. - [ ] Day 6: fatigue, nausea, dry mouth, injection arm numb/tingly. - [ ] Day 7: fatigue, nausea, dry mouth, mild migraine, lower abdominal pain - [ ] Day 8: nausea, abdominal pain
33 2021-02-02 itchy skin, hives, redness I had a mild anaphylactic reaction five minutes after getting the vaccine. The hives and tight thro... Read more
I had a mild anaphylactic reaction five minutes after getting the vaccine. The hives and tight throat went away after several doses of medication. The redness and itching last 4-5 days. I had to stay on Benadryl and Zyrtec to help with the redness and itching. My job sent me to the ER to be monitored after getting the shot until I went home. The fatigue lasted for a whole week.
33 2021-02-02 injection site pain, injection site redness, injection site warmth, injection site swelling Injection site became red, warm, painful and swollen soon after vaccination. Ten days after first va... Read more
Injection site became red, warm, painful and swollen soon after vaccination. Ten days after first vaccination, site began to improve. Recommended warm compress, measure and monitor swelling and Tylenol. No medical care needed.
33 2021-02-02 injection site redness, injection site swelling, injection site pruritus Injection site swollen, red and itchy
33 2021-02-03 vaccination site pain injection site pain; Very sore muscle pain in left arm; This is a spontaneous report from a contacta... Read more
injection site pain; Very sore muscle pain in left arm; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech Covid vaccine, lot EL3249), via an unspecified route of administration in the left arm 22Jan2021 11:00 at SINGLE DOSE for Covid-19 immunisation. Medical history includes diagnosed with COVID-19 prior to vaccination. She was taking Daily women's vitamins within 2 weeks of vaccination. The patient experienced injection site pain, very sore muscle pain in left arm on 22Jan2021. No treatment was given. The outcome of events was recovering. Since the vaccination, the patient has not been tested for COVID-19.
33 2021-02-04 itchy skin, rash Fever - 101.3 degrees for 24 hrs Itchiness with red dots - on back, arms, legs - 2 days later still... Read more
Fever - 101.3 degrees for 24 hrs Itchiness with red dots - on back, arms, legs - 2 days later still having itchiness but fever has subsided.
33 2021-02-04 rash Rash on neck/ shoulders/ upper back; This is a spontaneous report from a contactable consumer (patie... Read more
Rash on neck/ shoulders/ upper back; This is a spontaneous report from a contactable consumer (patient) A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 16Jan2021 at single dose. Medical history included spasmodic dystonia and migraines. The patient's concomitant medications were not reported. On 18Jan2021, approximately 36 hrs after injection, patient experienced rash on neck/ shoulders/ upper back with outcome of unknown.Information on the batch number has been requested.
33 2021-02-05 itchy skin 3 weeks ago with 1st dose patient experienced itching all over body. Today 2/5/21 ~0915 pt. receive... Read more
3 weeks ago with 1st dose patient experienced itching all over body. Today 2/5/21 ~0915 pt. received 2nd dose of Pfizer COVID vaccine. Within 5 minutes patient felt intense itchiness (greater than last time). Today she is now feeling tightening and swelling feeling in her throat. At ~0920 given diphenhydramine 25mg po and at 0930 given famotidine 20mg po. Symptoms are resolving while under observation and patient is being picked up by father so she does not drive.
33 2021-02-05 hives I was eating food that I normally eat and I looked down at my right arm and saw decent amount of hiv... Read more
I was eating food that I normally eat and I looked down at my right arm and saw decent amount of hives. Then I check the rest of my body and found more. I took benadryl and zyrtec on the 5th and then feel asleep. I woke up in the middle the night to see that they had doubled eone in my private parts. I went to urgent care and they gave me a steroid injection, prescriptions for pepcid, a steroid pack and told me to continue to take the benadryl and zrytec. The hives have gone down, but I feel very weak and tired. It occured around 8:30 Friday night (2/5) and I am sorry I didn't fill out the form last night. i got the shot this morning at 8:30 am. I had a slight fever this morning.
33 2021-02-05 injection site pain, injection site swelling Injection site pain and swelling at time of injection. Pain lasting several days. Severe body aches ... Read more
Injection site pain and swelling at time of injection. Pain lasting several days. Severe body aches and nausea. Now 4 days out from receiving my 2nd dose and my arm still has a huge swollen knot the size of a fist. Arms is right and painful. Can physically see the knot/swelling.
33 2021-02-05 itchy skin, hives Patient presented to COVID-19 Vaccine clinic on 02/06/21. Patient reported the following allergies o... Read more
Patient presented to COVID-19 Vaccine clinic on 02/06/21. Patient reported the following allergies on immunization consent form: "cefdinir - anaphylactic". Patient took diphenhydramine (dose unknown) at ~4:00pm prior to appointment. Patient received 0.3mL Pfizer COVID-19 Vaccine at 4:17PM from pharmacist. Pt. noticed she was developing hives and itching. Nurse at vaccine clinic was monitoring and called EMS. At 4:47PM, patient reported difficulty swallowing and had facial hives. Epi-pen was administed by pharmacist - per Immunization Emergency Protocol. At 4:50pm, EMS arrived at clinic, and patient was taken via ambulance to emergency department for further treatment at 4:53pm. Current status unknown.
33 2021-02-07 injection site pain Approximately 3 hours after receiving the vaccine, patient developed slight soreness at injection si... Read more
Approximately 3 hours after receiving the vaccine, patient developed slight soreness at injection site (noticeably less than following dose 1 of this vaccine). Then, at approximately 12 hours post-dose, developed the following symptoms lasting the entirety of the night: generalized/dull headache, photosensitivity, generalized myalgias/arthralgias, subjective fever/chills alternating with cold sensitivity. All symptoms except headache resolved by the next morning, but at approximately 24 hours post-dose, all symptoms returned and lasted for the remainder of that day. By the next day, all symptoms had completely resolved and have since not recurred.
33 2021-02-07 itchy skin, hives allergic reaction to the product/ throat was swelling and started to close up/ hives and itching/ bl... Read more
allergic reaction to the product/ throat was swelling and started to close up/ hives and itching/ blood pressure dropped and heart rate increased/ chest tightness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old-female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL3248), via an unspecified route of administration into left deltoid on 21Jan2021 10:20 at a single dose for covid-19 immunization. The patient was allergies to sulfa medications and latex and she had the flu vaccine in Nov2020. The patient concomitant medications were none. The patient called to report on the COVID 19 vaccine and she had an allergic reaction to the product. The patient explained that she got the vaccine yesterday at around 10:20 am and was in the emergency room at 10:48 am. Her throat was swelling and started to close up and this has resolved after medication. She had hives and itching which are now ongoing and about the same, her blood pressure dropped and there was an increased in her heart rate which have both gotten better, and she had chest tightness which is about the same. She received IV Benadryl, Solumedrol, and Pepcid. The patient was treated and released from the emergency room. No investigation assessment. The outcome of the event was not recovered.
33 2021-02-07 rash vesicular burn-like lesion on top of right foot/started as a welt/looks like a blistered burn; sensation of lo... Read more
burn-like lesion on top of right foot/started as a welt/looks like a blistered burn; sensation of low-grade current flowing through hands and sporadically throughout limbs; This is a spontaneous report from a contactable consumer reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1283/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 at 14:45 (at the age of 33 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included latex allergy and allergy to some white cheeses. Concomitant medication was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021, the patient experienced sensation of low-grade current flowing through hands and sporadically throughout limbs, mostly for 2hrs following the shot, then occasionally afterward. On 21Jan2021 at 22:45 the patient experienced a burn like lesion on top of right foot, which started as a welt approximately 8 hours after the shot. By morning of second day after shot (23Jan2021), it looks like a blistered burn the size of a dime. The patient did not receive any treatment for these events. The outcome of the events sensation of low-grade current flowing and burn-like lesion on top of right foot/started as a welt/looks like a blistered burn was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
33 2021-02-08 hives Fever on day of injection. Patient stated developing hives throughout body yesterday, continues to h... Read more
Fever on day of injection. Patient stated developing hives throughout body yesterday, continues to have intermittent hives.
33 2021-02-08 skin discolouration Systemic: Other- patient had blueness in one hand, states she had problems breathing, and vomiting, ... Read more
Systemic: Other- patient had blueness in one hand, states she had problems breathing, and vomiting, epipen was given and paramedics were called, she was taken to the hospital, not believed to be anaphylaxis
33 2021-02-09 itchy skin, redness Toes swollen; painful feet; itchy; red on bilateral feet; This is a spontaneous report from a contac... Read more
Toes swollen; painful feet; itchy; red on bilateral feet; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN53.8), via an unspecified route of administration in left arm on 23Jan2021 12:30 at single dose for Covid-19 immunization in facility type of other. The patient's medical history included dysthymia, and there was no allergies to medications, food, or other products. Patient did not have any allergies to medications, food, or other products. Concomitant medication included bupropion within 2 weeks of vaccination in 2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient experienced toes swollen, painful feet, itchy, red on bilateral feet on 26Jan2021 08:00. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the events was not recovered.
33 2021-02-09 vaccination site redness, vaccination site swelling, vaccination site pain feeling unwell; Chills; extreme body aches; joint pain; headache; nausea; fever; injection site swel... Read more
feeling unwell; Chills; extreme body aches; joint pain; headache; nausea; fever; injection site swelling/redness/pain; injection site swelling/redness/pain; injection site swelling/redness/pain; This is a spontaneous report from a contactable other hcp. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 22Jan2021 16:15 for covid-19 immunisation. Medical history included hypothyroidism, drug hypersensitivity to penicillin, ceclor, bactrim, covid-19. Concomitant medications included letrozole, levothyroxine. No other vaccine was received in four weeks. The patient experienced feeling unwell on 23Jan2021 13:30, chills on 23Jan2021 13:30, extreme body aches on 23Jan2021 13:30, joint pain on 23Jan2021 13:30, headache on 23Jan2021 13:30, nausea on 23Jan2021 13:30, fever on 23Jan2021 13:30, injection site swelling/redness/pain on 23Jan2021 13:30. No treatment received. The outcome was recovering. Information on the Lot/Batch Number has been requested.
33 2021-02-09 skin discolouration left arm has a patch of discoloration; This is a spontaneous report from a contactable consumer, the... Read more
left arm has a patch of discoloration; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 15Jan2021 at 09:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Jan2021, the patient's left arm had a patch of discoloration which appeared approximately one week after the vaccination. The patient did not receive treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "left arm has a patch of discoloration" was unknown.
33 2021-02-10 vaccination site swelling, vaccination site pain Swelling and tenderness at vaccine site; Swelling and tenderness at vaccine site; This is a spontane... Read more
Swelling and tenderness at vaccine site; Swelling and tenderness at vaccine site; This is a spontaneous report from a contactable non-healthcare professional reported for herself that. This 33-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247) via an unspecified route of administration at left arm on 22Jan2021 02:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism and seasonal allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), BUSPIRONE HYDROCHLORIDE (BUSPAR), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC), and birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced swelling and tenderness at vaccine site on 23Jan2021 06:00 AM. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. Seriousness criteria was reported as non-serious.
33 2021-02-11 rash Headache (a couple hours after injection both times), Tired (a couple hours after injection both tim... Read more
Headache (a couple hours after injection both times), Tired (a couple hours after injection both times), and Rash (various places, 2 days after each injection, lasted for over a week from first injection, second injection is also causing small rashes in various places already- similar to systemic poison ivy that I had this past summer)
33 2021-02-14 cellulitis A patient received a Pfizer covid-19 vaccination (lot number: EL3249) on 01/30/2021. This was her se... Read more
A patient received a Pfizer covid-19 vaccination (lot number: EL3249) on 01/30/2021. This was her second dose (first dose: 01/08/2021). The patient reported no history of serious adverse events following vaccine administration during her vaccine screening. After receiving the vaccination, the patient developed cellulitis on her arm and chest. Based on my chart review, the patient does not have an encounter documenting the reaction, and no antibiotics were prescribed. The ADR report has a severity of harm ? temporary, intervention needed, but I do not see a documented intervention in EPIC. It is unclear how long after the immunization that the patient developed cellulitis.
33 2021-02-14 injection site pruritus Nurse Practitioner Family Medicine COVID VACCINE CLINIC 2/12/2021 Patient: ... Read more
Nurse Practitioner Family Medicine COVID VACCINE CLINIC 2/12/2021 Patient: Date: 2/12/2021 Subjective Patient is a 33 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching at vaccine site. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to increased swelling, rapid progression of symptoms, skin changes and tongue swelling. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies facial swelling, sore throat, frequent throat clearing, chest tightness, shortness of breath and wheezing Previous Reactions: adhesive reactions. Objective Vitals Vitals: 02/12/21 1155 BP: 130/85 Pulse: (!) 108 SpO2: 100% Physical Exam Nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Pulmonary: Effort: Pulmonary effort is normal. Skin: General: Skin is warm and dry. Comments: Slight irritation noted around the adhesive location of band-aid. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Encouraged for her to avoid adhesives. Adhesive reaction added to allergy list.
33 2021-02-14 dry skin, skin tightness Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead ski... Read more
Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead skin got tight and dry, now I've lost vision in my right eye! Today is exactly 2 weeks after 1st vaccine and sight in my right eye is worse and painful
33 2021-02-15 injection site pain 1 hour after injection on 2/15/21 - facial numbness and tingling, starting in nose and spreading thr... Read more
1 hour after injection on 2/15/21 - facial numbness and tingling, starting in nose and spreading through face. Symptoms resolved in a couple hours The morning following vaccination 2/16/21 - pain in left arm spreading from injection site down the back of shoulder and arm. Widespread pain in joints. Muscular fatigue. Some relief with NSAIDs. Currently managing at home
33 2021-02-16 hives Several hives which went away without treatment within 2-3 hours
33 2021-02-16 rash Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal.... Read more
Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal. Sore throat, fluid in ears and lungs. Muscle weakness, headaches...difficulty walking. Insomnia. Flu like symptoms for 2 weeks after dose2. Nerve pain (shooting sensation down both arms. Difficulty standing for more than a few minutes, light headed. Ear pain, nausea, night sweats and unable to grasp normally. Tingling in face. Numbness in face.
33 2021-02-17 vaccination site pain Sore arm at the injection site; slight headache; This is a spontaneous report from a contactable con... Read more
Sore arm at the injection site; slight headache; This is a spontaneous report from a contactable consumer (Pfizer colleague) reported for herself. A 33-year-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at left arm on 28Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history was none. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had no other medications received within 2 weeks of vaccination. The patient experienced sore arm at the injection site, and a slight headache both on 29Jan2021. The patient did not receive treatment for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The outcome was recovering. The seriousness from reporter was non-serious.
33 2021-02-17 vaccination site pain arm was killing her for 2 days after the first dose; This is a spontaneous report from a contactable... Read more
arm was killing her for 2 days after the first dose; This is a spontaneous report from a contactable health care professional (patient). A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 07Jan2021 on the arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient has not been diagnosed with COVID-19. The patient stated that her arm was killing her for 2 days after the first dose on an unspecified date in Jan2021. The outcome of the event was unknown. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested
33 2021-02-18 skin warm Employee received first Covid19 vaccination on 12/31/2020. Five days post vaccination developed swe... Read more
Employee received first Covid19 vaccination on 12/31/2020. Five days post vaccination developed swelling in left neck per employee larger than tennis ball, tender to touch,warm to touch slightly painful to touch . Size has decreased daily to now the size of tennis ball today. Did not report until today. Covid EHS notified and employee will also call them.
33 2021-02-21 redness Patient became dizzy with palpitations. Developed flushing, sweating and shaky, take to Emergency r... Read more
Patient became dizzy with palpitations. Developed flushing, sweating and shaky, take to Emergency room where a patient developed minimal residual erythema
33 2021-02-21 rash with redness, rash, itchy rash Patient c/o feeling lightheaded 5 minutes after administration. BP was normal. Gave cold water. Deve... Read more
Patient c/o feeling lightheaded 5 minutes after administration. BP was normal. Gave cold water. Developed itchy red rash across chest ~8 minutes after administration. This began to fade ~15 minutes after administration, but patient then complained that tongue felt funny & began clearing throat. After consulting with our NP, Epipen was administered (0.3mg), & 911 called. Transported via ambulance ED. Pt reported tongue feeling better after Epipen.
33 2021-02-21 redness, itchy skin, rash macular Patient was being held for monitoring after receiving the COVID-19 vaccine. Within 1-2 minutes, pat... Read more
Patient was being held for monitoring after receiving the COVID-19 vaccine. Within 1-2 minutes, patient developed facial redness and itching. She then started to feel as if her throat was itchy and started coughing uncontrollably. Denied lip or tongue swelling. Was feeling normal prior to receiving the vaccine. Was not recently seen/assessed for other medical care. No similar symptoms previously. Patient was taken to the Emergency Department. Ptaient did have a few red splotches on her chest, but these did not appear consistent with urticaria per the ED physician's report. ED physician felt patient's symptoms may be secondary to anxiety. However, given history of anaphylaxis and feeling of throat itching it was felt necessary to treat for possible allergic reaction. Patient was given epinephrine, Benadryl, famotidine, and Solu-Medrol. She was then monitored in the ED for 4 hours. During this time, she developed no new symptoms. She continued to breathe easily with normal and stable vital signs. She was discharged with instructions to buy OTC Benadryl 25mg PO to take every 8 hours for 48 hours. Prednisone 20mg, 3 tablets orally daily for 5 days weas prescribed. An EpiPen was also prescribed. Patient advised not to receive second dose of the vaccine and to follow up with her primary care provider.
33 2021-02-21 itchy skin, hives, skin swelling poofyness, itching (hives), shortness of breath, headache, dizziness when upright, joints hurt micr... Read more
poofyness, itching (hives), shortness of breath, headache, dizziness when upright, joints hurt microdosing benadryl, inhaler
33 2021-02-22 rash I received the vaccine on 02/11/21 and am breastfeeding my 7-month-old daughter. The next morning, ... Read more
I received the vaccine on 02/11/21 and am breastfeeding my 7-month-old daughter. The next morning, my daughter had a rash throughout her stomach. The rash appeared to flare up after feedings. I stopped breastfeeding for 12 hours and the rash was resolved. She was seen at pediatrician for this issue.
33 2021-02-22 injection site pruritus, injection site redness, injection site warmth, injection site rash, injection site swelling Rash below injection site. Currently lasting 2+ days. Slight growth in size. Red, warm to touch, itc... Read more
Rash below injection site. Currently lasting 2+ days. Slight growth in size. Red, warm to touch, itchy, swollen.
33 2021-02-23 redness 9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and... Read more
9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and face flushed red & hot; my ears and face flushed red & hot; coughing; choking; couldn't breathe; My throat was swelling up so fast and filling with a thick mucous; My throat was swelling up so fast and filling with a thick mucous; she was not coherent enough to remember it; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Feb2021 15:00 for Covid-19 immunisation, administered at hospital. Medical history included asthma, gastrooesophageal reflux disease (GERD), endometriosis, adenomyosis, polycystic ovaries (PCOS), anaphylactic reaction Known allergies: fried chicken/fast food unknown preservative (anaphylactic). Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: levonorgestrel (MIRENA), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL). No other vaccine in 4 weeks. The patient previously took cyclobenzaprine and experienced dust allergy, metronidazole and experienced drug hypersensitivity, cephalexin and experienced drug hypersensitivity, tramadol and experienced anaphylactic reaction. On 17Feb2021 03:15 PM, 9-10 min after getting the shot, her lungs felt like she was running a marathon. She told the observer and before she finished describing her chest pain, her ears and face flushed red & hot. She called for a stretcher and she started coughing. They got her on a stretcher & ran her to the ER down the hallway. She was coughing and choking and couldn't breathe. Her throat was swelling up so fast and filling with a thick mucous. Patient received treatment with an epinephrine shot, solumedrol shot, Benadryl shot & started an iv steroid that started with a V sound (between choking/epinephrine/Benadryl, she was not coherent enough to remember it). Within a few minutes her coughing subsided and she was able to breathe normally. She received an albuterol treatment at that point. She was kept under observation for 5 hours. At about the 4 hour mark she had another albuterol treatment. She has continued albuterol treatments every 4 hrs. Oral Prednisone, oral Benadryl. It's hills immediately after meds, valleys between. Patient was not tested for covid post vaccination. AEs resulted in: doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Reactions were ongoing. The outcome of events was recovering.
33 2021-02-23 itchy skin, injection site redness Bruise at vaccination site day after that has not gone away Red mark beneath vaccination site that g... Read more
Bruise at vaccination site day after that has not gone away Red mark beneath vaccination site that grew in size. Yesterday was approximately 4 inches in diameter and red. Treated with hydrocortisone cream and redness has reduced slightly, but spot is still there and moderately itchy.
33 2021-02-23 itchy skin Pt complained of itching and warm feeling no sob or dizziness. Was evaluated by EMS, they recommende... Read more
Pt complained of itching and warm feeling no sob or dizziness. Was evaluated by EMS, they recommended giving liquid benadryl 25mg. Pt vitals sign BP 132/78 R 20 P 78 o2 97%. PT reported feeling better after receiving the benadryl waited an additional 30 mins before leaving. Refused any other treatment.
33 2021-02-24 rash, rash vesicular, itchy skin Body rash with extreme itching. Has not gone away with steroids or antihistamines. Day 22 days out ... Read more
Body rash with extreme itching. Has not gone away with steroids or antihistamines. Day 22 days out and the rash is still here. My skin feels like it?s crawling and itchy. Majority of the rash had been on my back, neck and recently my left back/armpit. Very painful and blistering.
33 2021-02-25 sensitive skin, injection site pain, injection site rash She received her second dose of COVID 19 vaccination (Pfizer) in left deltoid the afternoon of Febru... Read more
She received her second dose of COVID 19 vaccination (Pfizer) in left deltoid the afternoon of February 23, 2021. That night and since then she has been experiencing insomnia. The day after she received the injection she developed head pressure, and head ache, body aches, rash around the injection site, pain at the injection site, and her arm is very sensitive. She went to the emergency room with complaints of abdominal pain and headache. She is not sure if the abdominal pain is related to the vaccination. Imaging studies performed in the ED revealed she has a cyst on left ovary, and a kidney stone in left kidney. She was prescribed cefdinir 300mg, take one tablet by mouth twice a day for seven day, and acetaminophen-codeine 300-30. She is taking cefdinir 300mg, one tablet by mouth twice a day. She is not taking acetaminophen-codeine 300-30. The day after she was seen in the ED she found a lump at the bottom of her left underarm. The lump is hard and the size of a quarter.
33 2021-02-26 itchy rash Nausea, dizziness, headache, body aches - began 2 hours after vaccine, ended 36 hours later. Bliste... Read more
Nausea, dizziness, headache, body aches - began 2 hours after vaccine, ended 36 hours later. Blistery rash on hands, wrists, feet, arms, thighs, abdomen, face, and neck began 2 days after vaccine and continued for 10 days. Rash was very itchy and Benadryl did not help.
33 2021-02-26 injection site swelling, injection site redness Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Tingling (spe... Read more
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: After the injection I noticed a swelling and a little red on the injection site. After monitoring her pt stated that she has some tingling on her right thumb and monitored by NP for about 40min to an hour and felt ok and went home and an hr later called for follow up and she was 100% better. she was given water while here. rph spoke to her family member while she was here. and I called her about 8:39pm and spoke with her and she said she is doing ok.
33 2021-02-27 injection site redness, injection site pruritus, injection site pain, injection site mass Vaccine received at 4pm on 1/31. Nausea, headache, fatigue, marked arm soreness, and injection site ... Read more
Vaccine received at 4pm on 1/31. Nausea, headache, fatigue, marked arm soreness, and injection site lump started the following morning. Normal temperature. All symptoms, including arm soreness and lump, resolved in 48 hours. 7 days post vaccine, on 2/7, Injection site lump returned, and became larger than initial reaction. Area around lump (~6in in diameter) was red and extremely itchy. Area was painful, but much less so than initial reaction. Resolved on own within 3 days.
33 2021-02-27 injection site redness, injection site pain, injection site pruritus Vaccine received at 4pm on 2/21. Nausea started the next morning, followed later by fever (highest a... Read more
Vaccine received at 4pm on 2/21. Nausea started the next morning, followed later by fever (highest at 101.8), body aches, chills, headache, and mild arm soreness. All symptoms resolved within 24 hours, except mild arm soreness. Arm soreness continued for 5 days, and a red, itchy, and painful area was noted approximately 2 inches away from injection site during this time. All symptoms resolved on own.
33 2021-02-27 dry skin, shingles Within the week of getting the shot, my skin became extremely dry and my skin would crack. Exactly 2... Read more
Within the week of getting the shot, my skin became extremely dry and my skin would crack. Exactly 2 weeks after getting the dot i got Shingles
33 2021-02-28 injection site rash, rash with redness, itchy skin Growing red rash at site of injection, getting progressively more itchy as time goes on. Antihistam... Read more
Growing red rash at site of injection, getting progressively more itchy as time goes on. Antihistamines have helped relieve the itching.
33 2021-03-01 itchy skin 2/20/21- ?Vaso/vagal vs anaphylaxis, approx 1:20 PM, 10-15 min post vaccine, HA, approx 1:30PM nause... Read more
2/20/21- ?Vaso/vagal vs anaphylaxis, approx 1:20 PM, 10-15 min post vaccine, HA, approx 1:30PM nausea, dizzy, unable to stand on own BP 120/78, low for ct, O2 8L/simple mask, 911 called, throat felt dry, anxious, denied airway prob, no wheezing or stridor, epi not indicated, FIRE/EMS arrived, after a few minutes client able to stand on own, declined going to hospital, felt well enough to drive 20" home. 2 hrs post vaccine, throat scratchy, back became itchy, took Benadryl x 2 with resolution after 2nd dose, At 3:45, spoke County Manager, ct kept feeling the need to clearher throat, ct referred to PCP. 02/25-Client feeling fine now,spoke w/PCP, cleared to get 2nd dose at hospital. Ct has hx asthma/smg
33 2021-03-01 injection site rash, injection site pruritus Itchy at injection site that has lasted several days off and on. A small rash has formed after scrat... Read more
Itchy at injection site that has lasted several days off and on. A small rash has formed after scratching the area
33 2021-03-02 hives, itchy skin Patient started to have hives and itching within a few minutes of the injection given. She has a hi... Read more
Patient started to have hives and itching within a few minutes of the injection given. She has a history of allergies to medications and other things however not to a vaccine. She was given Benadryl 50mg (08:36) right away and had no vomiting. Her vital signs remained stable. She continued to progress with throat itching, tightness, and coughing. She was given an EPI PEN 0.3mg autoinjection at 08:42 and EMS was called. Her pulse ox decreased to 89% on RA until about 1.5 minutes after the EPI was given. Then it improved for a short time. At 08:50 her symptoms started to return and she had some audible stridor. EPI PEN 0.3mg autoinjection was repeated at 08:52. Ems arrived and she was transported.
33 2021-03-02 hives, itchy skin, rash Rash, hives, moderate itching. Continued until antihistamine taken 5 hours later. Continued to a mil... Read more
Rash, hives, moderate itching. Continued until antihistamine taken 5 hours later. Continued to a mild degree even after taking antihistamine more than 24 hours later.
33 2021-03-02 rash Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normal... Read more
Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient). A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-03-02 injection site pain injection site soreness ~4 hours after vaccine injection; Fatigue set in ~12 hours after vaccine inj... Read more
injection site soreness ~4 hours after vaccine injection; Fatigue set in ~12 hours after vaccine injection; Chills set in ~14 hours after vaccine injection; feverish ~17 hours after injection
33 2021-03-03 injection site pain Initial reaction occurred approximately ten hours after the vaccine, chills and injection site soren... Read more
Initial reaction occurred approximately ten hours after the vaccine, chills and injection site soreness, exhaustion next day hot flashes and body pain, following day (day3) just tired thought it was getting better then day 4 extreme dizziness, nausea, exhaustion, increased body pain especially behind left shoulder day 5 and today same
33 2021-03-03 itchy skin, hives Patient developed severe itching and hives. Felt warm, no SOB. 10ml(liquid) Benadryl administered... Read more
Patient developed severe itching and hives. Felt warm, no SOB. 10ml(liquid) Benadryl administered PO and 911 called. Assessed by the medics: 141/86, SR - 92, O2Sat 100% Transported to the emergency room for further assessment
33 2021-03-03 shingles Shingles presented on 3/1/2021; however, I had never experienced chicken pox symptoms in my childhoo... Read more
Shingles presented on 3/1/2021; however, I had never experienced chicken pox symptoms in my childhood so I was not aware I could get shingles. I treated the rash as if it were dermatitis until 3/4 when a medical professional diagnosed shingles.
33 2021-03-03 bruising, skin spots flare up of my autoimmune thrombocytopenia; Platelets dropped to 109k; legs covered in petechiae and... Read more
flare up of my autoimmune thrombocytopenia; Platelets dropped to 109k; legs covered in petechiae and bruising; legs covered in petechiae and bruising; After 2nd dose, 1 day of headache; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK4176 intramuscular in left deltoid on 07Jan2021 as single dose (at the age of 33 years) for COVID-19 immunisation. Patient had history of ongoing Autoimmune Thrombocytopenia from May2020, ongoing migraines, depression/anxiety and ADHD, and COVID-19 21Apr2020 to "05May2021". Concomitant medication included Sertraline Hydrochloride (ZOLOFT), Lisdexamfetamine mesilate (VYVANSE), Lorazepam (Ativan), Ondasetron (ZOFRAN) and Sumatriptan succinate (IMITREX). Historical information regarding dose 1 of BNT162B2 on 17Dec2020 included a moderate injection site reaction lasting 6 days worst on day three. Reaction was characterized by redness, swelling elevated rash surrounding injection site, aching pain radiating from neck to fingers and tenderness to palpitation. 1st dose Vaccine Lot Number: EJ1685, Vaccine Lot Expire Date: Mar2021, Time the Vaccination Was given: 08:00. After the 2nd dose the patient experienced a moderate headache on 08Jan2021 12:00 for 1 day which responded well to APAP- caffeine and resolved on 09Jan2021 12:00 Patient had a flare up of my autoimmune thrombocytopenia as evidenced by legs covered in petechiae and bruising on 09Jan2021. Emergency room and physician office were not visited however, patient does have standing CBC orders from hematologist, so she had platelet count checked. It had dropped to 109K/uL, which is low for me but not dangerous. Patient originally developed autoimmune thrombocytopenia (ITP) May2021 after COVID Apr2021. Both instances of these side effects were manageable, but patient wanted to report them as there was no data yet available on ITP with the vaccine when she met with hematologist to discuss it. Patient received Acetaminophen 650mg PO (per oral) as treatment. Lab data included Platelets 13Oct2020 124 kiU/L (normal 140-400) and on 12Jan2021 109 KiU/L. Event flare up of my autoimmune thrombocytopenia resolved on 31JAN2021 00:00, Platelets dropped to 109k resolved on 31JAN2021 00:00, legs covered in petechiae and bruising resolved on 31JAN2021 00:00 and headache resolved 09Jan2021.
33 2021-03-04 redness Arm redness, swelling and soreness
33 2021-03-04 injection site pain I received my first dose of the Pfizer COVID-19 Vaccine on 3/2/2021 in my left arm. After approx. 30... Read more
I received my first dose of the Pfizer COVID-19 Vaccine on 3/2/2021 in my left arm. After approx. 30 minutes of receiving my shot my left side of my face felt numb including the left side of my tounge as well as muscle pain and soreness on the left side on the back of my neck. Today is 3/5/2021, my face is slowly becoming less numb over time and rest. I also experienced fatigue and injection site soreness. I am particularly concerned about my face becoming numb shortly after receiving my vaccine and I am wondering if I should get a second dose when I need to?
33 2021-03-05 injection site bruising Fever, extreme joint pain, bruising at injection site, arm fever at injection site, week and then mo... Read more
Fever, extreme joint pain, bruising at injection site, arm fever at injection site, week and then mobile for a day.
33 2021-03-05 hives, skin reaction Hives and skin reactions 24 hours after to current
33 2021-03-07 rash 3/7/2021 7:00 AM - Experiencing weakness, fatigue, chills, nausea, chest pain upon inhaling, rashes ... Read more
3/7/2021 7:00 AM - Experiencing weakness, fatigue, chills, nausea, chest pain upon inhaling, rashes on other parts of the body. 3/8/2021 Experiencing sore throat, weakness, fatigue, headache, migraine, dizziness, brain fog, nausea, decrease in appetite, and rashes on other parts of the body.
33 2021-03-07 rash, shingles Blisters/Shingles/positive for Varicella zoster virus DNA, PCR; rash; ear started swelling; lymph no... Read more
Blisters/Shingles/positive for Varicella zoster virus DNA, PCR; rash; ear started swelling; lymph node swelling under her ear/lymph swelling increased to quarter size; shooting pain in my right ear; Headache; chills; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) intramuscular on 27Jan2021 15:30 in left arm at single dose for COVID-19 immunization. The patient did not have Covid prior vaccination. The patient did not have covid tested post vaccination. No known drug allergies and no other medical history. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced headache and chills 3 days after Covid vaccine on 30Jan2021. On 03Feb2021, she had shooting pain in her right ear. On 04Feb2021, her ear started swelling, she also noticed her lymph node swelling under her ear. On 05Feb2021, chills, lymph swelling increased to quarter size with a rash under her jaw line and earlobe; she made an appointment with her PCP and was given Ceftin 500 mg two times a day for 7 days. She had blisters on the back of her earlobe on 07Feb2021. On 07Feb2021, she noticed more blisters in front of her right earlobe and on the rash under her jaw line. On 07Feb2021, she went to urgent care and was diagnosed of shingles, given valacyclovir (VALTREX) 1 mg three times a day for 7 days. On 10Feb2021, culture came back positive for Varicella zoster virus DNA, PCR. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
33 2021-03-07 vaccination site pain Generally unwell; Fever; sever body aches; injection site Pain; Chills; lymph node swelling on side ... Read more
Generally unwell; Fever; sever body aches; injection site Pain; Chills; lymph node swelling on side of injection; This is a spontaneous report from a non-contactable consumer. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 33) single dose arm left on 04Feb2021 10:30 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose of BNT162B2 right arm on 14Jan2021 03:00PM. No other vaccine was received in four weeks. The patient experienced generally unwell, fever, sever body aches, injection site pain, chills, lymph node swelling on side of injection, all on 05Feb2021 12:00. The events outcome was not recovered. No follow-up attempts are possible. No further information is expected
33 2021-03-08 injection site swelling, injection site redness, injection site warmth The injection site is raised and the size of a quarter. It?s red and has a fever. My left arm is in ... Read more
The injection site is raised and the size of a quarter. It?s red and has a fever. My left arm is in sore. It has felt this way since a few hours after getting my shot yesterday morning. Also I have been tired since getting the shot yesterday.
33 2021-03-08 injection site pain, injection site redness, injection site swelling Where injection site was turned red and swollen and tender to touch.
33 2021-03-09 vaccination site mass, injection site discomfort, injection site redness, vaccination site swelling Immediately after vaccination (2/27) I felt a lot of pain in my left arm. The soreness lasted for a... Read more
Immediately after vaccination (2/27) I felt a lot of pain in my left arm. The soreness lasted for about 48 hours then went away. I had other symptoms (headache, body aches, dizzyness, nausea, exhaustion). After about 4 days, I had no more symtpoms. I was regularly exercising during this time, so symptoms were not debilitating. On Sunday 3/7 I woke up to a lot of pain in my armpit and side chest. It hurt a lot. I still went for a run (7 miles). On Monday 3/8 I went for a 4 mile walk. After walk, the site of vaccination (upper left arm) was swollen and red, felt sunburned. It appeared very suddenly midday. I noticed there was a large lump under the skin. I felt aches in my hand, left shoulder, and left side of chest. No respitory problems, only muscular. On tuesday 3/9 the pain did not go away. I went to urgent care and was told it was a delayed allergic reaction. Vitals were said to be okay. Doctor advised usling a sling to relieve weight/pressure. Told to take Benadryl.
33 2021-03-09 vaccination site pain Insomnia; headache; fatigue; pain at injection site; This is a spontaneous report from a contactable... Read more
Insomnia; headache; fatigue; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in the left arm, on 06Feb2021 at 17:45, at single dose, for COVID-19 immunisation. Medical history included asthma. Patient did not experience COVID-19 prior to vaccination. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) and loratadine (CLARITINE ALLERGY). The patient experienced insomnia (non-serious) on 06Feb2021 at 20:00 with outcome of recovering, headache (non-serious) on 06Feb2021 at 20:00 with outcome of recovering, fatigue (non-serious) on 06Feb2021 at 20:00 with outcome of recovering, pain at injection site (non-serious) on 06Feb2021 at 20:00 with outcome of recovering. No therapeutic measures were taken as a result of the events. Patient did not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.
33 2021-03-09 hives Severe hives from chest down 3 days later; This is a spontaneous report from a contactable consumer ... Read more
Severe hives from chest down 3 days later; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Elo142, on 02Feb2021 17:00 at single dose in left arm for COVID-19 immunization. Medical history was not reported. Concomitant medication was none. The patient previously received first dose of BNT162B2 (Lot number= El9264 or 9) on 12Jan2021 04:30 AM in left arm. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no known allergies. The patient had Severe hives from chest down 3 days later on 05Feb2021 20:30. The event resulted in Emergency room/department or urgent care. Treatment received for the event included Steroid shots and package. The outcome of the event was resolving.
33 2021-03-09 vaccination site pain body aches; chills; my back started aching; feeling feverish but no fever; felt like a headache was ... Read more
body aches; chills; my back started aching; feeling feverish but no fever; felt like a headache was coming on/was going to get a headache; her arm hurt/arm pain/iced the injection site; never falling back asleep; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 15:15 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. After 2nd vaccine. The patient felt fine most of the evening and through the night. The patient woke up in the middle of the night around 3/3:30 am (totally normal for her) and felt fine except for some arm pain on 05Feb2021. The patient iced the injection site, but by 4:30/5 the patient was still awake and now felt like she was going to get a headache (also common for patient). The patient took her temperature (was normal), took 2 Tylenol (5am), and went back to bed (but never falling back asleep). The patient left for work at 6:45am. The patient felt totally fine, even energetic, most of the morning. The following day at 10 am caller reported body aches and feeling feverish but no fever. At almost 10am exactly, her back started aching and by 10:30 the patient had full body aches and started getting chills. The patient left work at 11am, was home before 12pm with a temperature of 98.5, took 2 more Tylenol and napped. The patient had no symptoms the rest of the afternoon until 5pm when the back aches returned. Took 2 more Tylenol. The patient napped later in the evening, too, but took 2 more Tylenol at 10pm before going to sleep for the night. Woke up Saturday morning without symptoms. The outcome of events was recovered in Feb2021. Information about Lot/batch number requested.
33 2021-03-10 hives Client developed hives to the arms, chest, and back approximately 5 minutes after vaccination. Para... Read more
Client developed hives to the arms, chest, and back approximately 5 minutes after vaccination. Paramedic checked lungs and temperature, both WNL. Client's mother provided Benadryl. Stayed for approx 45 minutes for observation. Advised client's mother that she should not receive 2nd COVID vaccine and she verbalized understanding. Prior to departure, client's hives improved.
33 2021-03-10 itchy skin The patient received 2nd dose of Pfizer Covid vaccine in left upper arm at 1230 today. While she was... Read more
The patient received 2nd dose of Pfizer Covid vaccine in left upper arm at 1230 today. While she was sitting in the waiting area for monitoring, she soon developed a sore/dry throat, difficulty breathing, and felt "strange". She also felt itchy, but had no local injection site reaction, rash, or hives. The first dose of epinephrine administered at 1251; patient developed a dry cough, anterior throat pain with difficulty swallowing, HA, dizziness, and chest heaviness. A second dose of epinephrine was given at 1301. EMS administered 25 mg of IV benadryl, and she started to have relief of her symptoms. She denies any nausea, vomiting, or palpitations. The patient states her throat still feels sore and itchy, but there is no obvious swelling at this time. She was monitored in the Emergency Department and discharged home.
33 2021-03-11 injection site pruritus, injection site pain, vaccination site pain, vaccination site rash, injection site redness 7 days after vaccine, after injection site/arm pain had subsided, vaccination site and surrounding a... Read more
7 days after vaccine, after injection site/arm pain had subsided, vaccination site and surrounding area on arm became extremely sore, sensitive, itchy, and burning -- almost like a bee sting. This area of my arm is very heavily tattooed so it's a bit tough to what's going on on the skin itself, but it appeared there may have been a rash -- bumps/texture and possible redness. This lasted about 3 days and then resolved completely.
33 2021-03-11 itchy skin Patient began to have full body itching, felt like she was going to pass out, difficulty breathing a... Read more
Patient began to have full body itching, felt like she was going to pass out, difficulty breathing and swallowing, and cough.
33 2021-03-12 redness, hardening Large hard red spot, sore, hot, full body burning up, tiredness.
33 2021-03-13 redness, itchy skin, hives One itchy red hive developed underneath left eye, within 4 hours of receiving vaccine dose 1
33 2021-03-14 injection site pain Head ache; Fever; Chills; Muscle soreness; Soreness at injection site; This is a spontaneous report ... Read more
Head ache; Fever; Chills; Muscle soreness; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (formulation: Solution for injection), via an unspecified route of administration in the Left arm on 01Feb2021 16:00 at single dose for covid-19 immunization. Medical history included asthma and Allergy to penicillin. Concomitant medication included drospirenone (SLYND), fish oil, vitamin D and berberine. On 01Feb2021, the patient experienced head ache, fever, chills, muscle soreness and soreness at injection site. On 01Feb2021, the patient underwent lab tests and procedures which included body temperature: fever. The outcome of the events was recovering. Information on the lot/batch number has been requested.
33 2021-03-14 rash with redness, rash, itchy rash I am currently 21 weeks pregnant. is due July 24th, 2021. This is my first pregnancy and I?ve had no... Read more
I am currently 21 weeks pregnant. is due July 24th, 2021. This is my first pregnancy and I?ve had no complications. NIPT results indicated no sign of issues. My 20 weeks ultrasound right after my first dose of the Pfizer vax went fine. I developed a rash on my chest days later. 9 days after receiving the vaccine. This is the first time this has ever happened to me. The rash on my chest is red, burning, and itching and has been there for 3 days now.
33 2021-03-14 injection site pain When receiving my second COVID vaccination, the nurse giving the injection measured one finger from ... Read more
When receiving my second COVID vaccination, the nurse giving the injection measured one finger from the top of my shoulder and injected just below, approximately 4cm from the top of my shoulder. It did not feel like a normal intramuscular injection. My arm has only been sore in my left shoulder, no where else. With any previous vaccine, including my 1st COVID injection, I have felt soreness in the muscle. I am more than sore in this case, I have pain that has woken me up from sleep.
33 2021-03-14 itchy skin Within 15 minutes - hot and flushed, headache. Dizzy. Fever onset first night. Lowgrade, sub 100.4.... Read more
Within 15 minutes - hot and flushed, headache. Dizzy. Fever onset first night. Lowgrade, sub 100.4. General bad feeling. Exhaustion, sore, muscle aches. Felt very hot and flushed even though fever was only 100. These symptoms lasted for 7 days. On day 3, Tuesday, I developed a dull aching pain in both arms. The feeling was like that of a charlie horse in your leg. Dull, painful, like slowly being crushed. Also felt hot pinpoints that itched all over my hands. My hands felt like they were burning, and the itchy pinprick feelings were mostly on my palms and fingers, but would sometimes present up towards my elbows. My hands were somewhat shaky, and still are. Once or twice my hand would flick involuntarily. The sore hurting arm feeling extends all the way up to my shoulder blades. On day 7 I went they gave me a steroid shot and a round of antibiotics. They said it was likely a sinus infection. The symptoms persisted one more day but then the fever resolved Wednesday night, Tylenol took it down and it didn't come back Thursday. The headache, sore back and neck, and arm pain persisted. It is now day 10. I am most concerned about the arm pain, tingling, and shaking. Please advise on whether I should get my second dose. I might go to a hospital for further testing if this doesn't resolve or if it progresses.
33 2021-03-15 itchy skin 1045 Pt reports not feeling well. C/O itching, nausea and dizzy. Appears calm. Color good-not pale... Read more
1045 Pt reports not feeling well. C/O itching, nausea and dizzy. Appears calm. Color good-not pale, lips pink and not diaphoretic. Water bottle given. Pt drank a 1/3 of bottle without difficulty. Remained seated in chair. 1048 Pt reports still not feeling well. Pt reports "still the same". Ambulated to examination/medical evaluation area. Pt ambulated independently, steady gait and no difficulty. No SOB, CP or itching noted. 1049 132/80 Calm, sitting. EMS contacted to come to assess per pt request. Report given to EMS. Pt stable and talking without difficulty. -FNP
33 2021-03-15 redness, rash, rash with redness 33y/o female presents with difficulty swallowing <10min after receiving the Pfizer vaccine in the le... Read more
33y/o female presents with difficulty swallowing <10min after receiving the Pfizer vaccine in the left arm on 3/16/21. She reports associated throat tightening, difficulty swallowing liquids, shortness of breath, nasal congestion, upper extremity/chest tingling, blurring of vision and feelings of anxiety. She denies lip/tongue swelling/tingling, itching or pain at site of injection. She has h/o allergies to shellfish, cats and bees. No known allergies to medications. Physical Exam: Vitals: BP 174/122, HR 78bpm Skin: non-pruritc erythematous rash of chest, generalized light redness of upper extremities bilaterally. No itching. Cardiac-regular heart rate and rhythm. Radial pulse 2+ Lungs-clear to auscultation bilaterally Plan: EMS was contacted immediately when PT reported difficulty swallowing. EMS placed patient in the ambulance at ~6pm and transported patient to Doctor's Hospital.
33 2021-03-16 vaccination site pain injection site pain the day after vaccination; This is a spontaneous report from a contactable Other... Read more
injection site pain the day after vaccination; This is a spontaneous report from a contactable Other HCP (patient). A 33-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: El2348) via an unspecified route of administration on 18Jan2021 at 15:00 (at the age of 33-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included ADHD and pneumonia 4 years prior, unspecified if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) included lisdexamfetamine mesilate (VYVANSE), trazodone, and daily multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 the patient experienced injection site pain the day after vaccination. The clinical outcome of the event injection site pain the day after vaccination was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
33 2021-03-16 injection site pain, injection site redness, injection site pruritus, injection site swelling injection site swelling, redness, pain and itching. no treatment. duration of 3 days
33 2021-03-17 injection site pain Arm pain is pretty bad. It began 30-60 minutes after the injection and had steadily gotten worse. I... Read more
Arm pain is pretty bad. It began 30-60 minutes after the injection and had steadily gotten worse. Injection site shows no redness or bruising, but the pain has been so bad it has interrupted sleep and is preventing me from being able to lift my arm or carry weight. 800mg Motrin and a heating pad seem to help, but I still have limited range of motion. This feels similar to the ache from a tetanus shot, just worse.
33 2021-03-17 injection site pain Client is a 33 y.o. female who received the Covid-19 Vaccine, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, L... Read more
Client is a 33 y.o. female who received the Covid-19 Vaccine, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/18/2021. The patient experienced the following reaction(s) during the immediate of observation: 2:35pm Patient with witnessed syncopal episode during observation period. + head strike and loss of consciousness. Patient gained consciousness after about 30 seconds. No seizure activity noted. Denies SOB and difficulty breathing. Patient alert and verbal. Patient was treated/managed as follows: 2:40pm VS BP 144/74, HR 99, RR 20, 99% on room air. Patient alert and oriented. C/o soreness to shoulder. Reports PMH psychogenic nonepileptic seizures induced by anxiety and stress, anxiety, and depression. 2:50pm VS BP 140/82, HR 87, RR 18, O2 sat 97% on room air. Patient reports mild headache and soreness to shoulder. 2:50pm 911 called. Patient given educational material regarding vaccine and advised to continue to self-monitor per the agency guidance. 3:17pm EMT arrived. VS BP 133/83, HR 83, RR 18, O2 sat 97% on room air. Patient reports feeling better. Patient refused transfer to hospital for further evaluation. 3:26pm Patient wheel chaired to car accompanied by mother, grandmother, and RN
33 2021-03-17 injection site warmth, redness, itchy skin, skin burning sensation, injection site redness, injection site swelling Day 4 - large warm red spot on left arm below injection site Days 5-6 - eyes swollen halfway shut, g... Read more
Day 4 - large warm red spot on left arm below injection site Days 5-6 - eyes swollen halfway shut, general face swelling, redness, itching and burning
33 2021-03-17 redness, itchy skin, hives On 3/15/2021 pt had redness below where injection given then on 3/16 (5 days after vaccine) had itch... Read more
On 3/15/2021 pt had redness below where injection given then on 3/16 (5 days after vaccine) had itchiness and hive on that arm then on face and red eyelid redness and facial puffiness (no lip/tongue swelling, no shortness of breath, no chest tightness, no wheezing, no lightheadedness)
33 2021-03-17 redness, skin mass, rash macular WIthin a few hours of receiving vaccine, patient developed pain, swelling, hypersensitivity, redness... Read more
WIthin a few hours of receiving vaccine, patient developed pain, swelling, hypersensitivity, redness and mottling of several toes bilateral feet and painful subcutaneous nodules on toes
33 2021-03-18 vaccination site pain Bleeding started really heavy/ Soaking up a bunch of different pads; Really bad pain in stomach as w... Read more
Bleeding started really heavy/ Soaking up a bunch of different pads; Really bad pain in stomach as well as right pelvic area; Really bad pain in stomach as well as right pelvic area; Pain in right chest area; bunch of pain; Headache; Diarrhea; Nausea; Pain where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200) via an unspecified route of administration in the left arm on 28Feb2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient mentioned that the only medication she was taking was birth control. The patient got the COVID-19 vaccine on Sunday and had the normal side effects like headache, diarrhea, nausea and pain where she got the shot. The patient took Excedrin extra strength on Sunday night. Then on Monday night (01Mar2021) when she went to sleep there was pain in her chest, her right chest area there was in a bunch of pain. When the patient woke up on Tuesday morning (02Mar2021), she had bleeding, and that bleeding started really, really heavy. She just came off of her period a week ago. She had a full blown period for an entire week and then on Tuesday the patient started bleeding very, very heavily. She was soaking up a bunch of different pads. She was not sure what it was, she had pain, really bad pain in stomach as well as like pain in her pelvic area, right pelvic area. Patient weight was 135 (units unknown). The outcome of the events was unknown.
33 2021-03-18 injection site hardening, injection site warmth, injection site redness, injection site swelling The arm started out with a solid red circle @ the injection site on the day of the injection Now t... Read more
The arm started out with a solid red circle @ the injection site on the day of the injection Now today, 9 days later it is red, measures 2' x 2' and is warm to the touch.
33 2021-03-18 hives developed hives 12 hours post vaccine
33 2021-03-19 itchy skin, hives, redness All over red, itchy hives
33 2021-03-19 injection site pain I got the usual arm pain at injection site the night after getting the vaccine. 24 hours later, I ha... Read more
I got the usual arm pain at injection site the night after getting the vaccine. 24 hours later, I had really bad diarrhea (possibly connected) but nothing else yet. 2 days after, i woke up with the normal fatigue, slight headache, and nausea from upset stomach. But what I did not expect was that 2nd night I got my period a week early and super heavy (I'm on birth control and haven't had my period, except for some spotting, in years). I spoke to some friends and a few of them suprisingly also reported extra heavy menstrual cycles or feeling like they were PMSing around 48 hours after. I couldn't find much online except for a bunch of random people complaining about the same thing, and no study or source of significance to back it. I'm wondering if this something they even looked out for? There seems to be a pretty strong correlation with certain people around my age just from asking around. And I don't think anyone who I spoke to even realized it could be connected until I mentioned it. It was just shocking and significant to me because I'm on set pills that I didn't miss, with no menstrual cycle issues, and I haven't bled more than spotting in years until this. It lessened the next day, and lessened again today since that symptom started.
33 2021-03-19 skin spots Petechiae on bilateral arms.
33 2021-03-19 injection site rash, itchy skin, rash with redness, rash papular, skin warm Raised red rash at injection site. Warm to the touch and approx 2 inches in diameter. Itchy.
33 2021-03-20 injection site pain Just had a mild headache all day on 3/20/2021 from am to pm headache was gone the next day. Didn?t t... Read more
Just had a mild headache all day on 3/20/2021 from am to pm headache was gone the next day. Didn?t take any medication for headache. Vaccine was given in the evening on 3/18/2021 - slight soreness at injection site, lasted for 3 days - is fine now.
33 2021-03-20 pain of skin, shingles Night of second dose, I had involuntary twitching in my arms and legs throughout the night that caus... Read more
Night of second dose, I had involuntary twitching in my arms and legs throughout the night that caused me to not be able to sleep. On 3/15, I began to feel pain on my skin. I developed a shingles rash on 3/16. I was diagnosed with shingles on 3/18.
33 2021-03-21 rash, skin warm High fever (102.7 at peak): 20 hours post vaccine, lasted 11 hours Diarrhea: 24 hours post vaccine, ... Read more
High fever (102.7 at peak): 20 hours post vaccine, lasted 11 hours Diarrhea: 24 hours post vaccine, lasted 24 hours Headache: 2 hours post vaccine, ongoing now (4 days out) Muscle and joint pain: 20 hours post vaccine, lasted 48 hours Swelling and rash on injection arm: 48 hours post vaccine, ongoing and spreading, hot to touch Exhaustion: 4 hours post vaccine, ongoing
33 2021-03-21 hives, itchy skin I noticed 2 small spots on my inner right thigh that were very itchy. At first, I thought it may ha... Read more
I noticed 2 small spots on my inner right thigh that were very itchy. At first, I thought it may have been a misquito bites, but I was wearing pants. The next day, I noticed several more similar itchy spots on my right arm, left arm around elbow, and my left ankle. The next day after that, I woke up with similar itchy spots along my jaw line. The spots are raised, itchy, small about the size of a pea, and seem to be in clusters of 2 or more. I have been outside this weekend, but did not notice any mosquitos or other bugs. These are bothersome only because they itch. And I've been treating with Cortoizone 10.
33 2021-03-21 redness In order of symptoms: Extreme facial Swelling and redness, hypotension, chest tightness, anxiety, sh... Read more
In order of symptoms: Extreme facial Swelling and redness, hypotension, chest tightness, anxiety, shortness of breath. Occurred at 10 pm ish on March 20.
33 2021-03-21 injection site pain Pain in muscle and bone on upper arm and shoulder that has not abated in several days; stiffness and... Read more
Pain in muscle and bone on upper arm and shoulder that has not abated in several days; stiffness and sharp pain near injection site; pain has become unmanageable even with ibuprofen
33 2021-03-21 itchy skin, rash, redness Severely itchy and red skin (rashes) on the front neck at night during sleep. It's gone better after... Read more
Severely itchy and red skin (rashes) on the front neck at night during sleep. It's gone better after waking up, but it is still bothersome and itchy (not as severe as at night).
33 2021-03-22 skin warm Patient complained of light-headedness, generalized chills, warmth to body, and palpitations at 10:0... Read more
Patient complained of light-headedness, generalized chills, warmth to body, and palpitations at 10:04 immediately after receiving vaccination. She did not eat breakfast. States she had similar reaction after receiving the first dose, which self-resolved after a minute. At 10:05, she was hypertensive and given water. At 10:25, patient verbalized feeling better and was able to ambulate without dizziness. At 10:33, she developed chills, mild rigors, and throat tightness. Blood sugar on low end of normal, tachycardic, and hypertensive, so patient was given an oatmeal bar and transferred to ED. Upon evaluation in ED at 10:49, patient stated symptoms had resolved. Patient was discharged at 12:22.
33 2021-03-22 rash Received 1st dose Pfizer COVID19 vaccine 3/19/2021. Throughout day, patient reported having "unusual... Read more
Received 1st dose Pfizer COVID19 vaccine 3/19/2021. Throughout day, patient reported having "unusual symptoms" (unspecified). In the evening, patient noticed rash on chin, face, and chest, itchiness of throat and tightness of breathing. Treated with epinepherine and benadryl in Emergency Department.
33 2021-03-23 injection site redness, injection site hardening, injection site swelling, hives, injection site warmth, itchy skin 3/2/21-Low grade fever and headache. 3/3/2021-Itching covering entire body started around 7PM. 3/5-... Read more
3/2/21-Low grade fever and headache. 3/3/2021-Itching covering entire body started around 7PM. 3/5-Hives started on face. 3/6- Injection site remained swollen, red, warm and firm to the touch. From 3/6-Present had hives moving all over body. Intense itch/burn at times that have been painful. Have been prescribed Atarax 25mg (3/6/2021) and increased to 50mg 3/10/2021, 7 day Medrol Dose Pak(3/10/2021), and a steroid injection (3/18/2021). As of today (3/24/2021) there has been no resolution. Hives continue to move over body, intense itching, and some pain.
33 2021-03-23 itchy skin EMS narrative: RESPONDED TO A SPECIAL EVENT1 CALL AT VACCINE CLINIC SITE- CONVENTION CENTER, FOR A ... Read more
EMS narrative: RESPONDED TO A SPECIAL EVENT1 CALL AT VACCINE CLINIC SITE- CONVENTION CENTER, FOR A 33 Y/O F, CC OF AN ALLERGIC REACTION. PT AMBULATED TO SE1 FIRST AID STATION AND REQUESTED SPECIAL OBSERVATION DUE TO ADVERSE/ALLERGIC REACTION AFTER HER 1ST COVID-19 VACCINE INJECTION. PT STATED THAT SHE HAD SWELLING ITCHING AND HIVES AFTER THE 1ST INJECTION, AND HER SYMPTOMS DEVELOPED PAST THE 15 MINUTE OBSERVATION WINDOW, AND PERSISTED FOR THE NEXT 1-3 HOURS, WITH PROGRESSIVE RELIEF FROM ADMINISTERED BENADRYL. SE1 AT THAT TIME ADMINISTERED 1 25MG ORAL BENADRYL, WITH POSITIVE EFFECT ALBEIT SLOW EFFECT. PT ARRIVED AT FIRST AID IMMEDIATELY AFTER RECEIVING HER SECOND VACCINE DOSE, AND REPORTED NO IMMEDIATE SYMPTOMS. AFTER 15 MINUTES PT STATED HER BACK AND EXTREMITIES WERE " A LITTLE ITCHY, AND SHE FELT PIN PRICKS IN HER FINGER TIPS." PT DENIED ANY SOB, CP, NAUSEA, VOMITING, HIVES, OR AIRWAY IRRITATION/COMPROMISE. PT WAS ADMINISTERED 25MG ORAL BENADRYL AT 1015, AND PT WAS OBSERVED FOR 45 MINUTES. PT STATED SHE FELT MUCH BETTER AND DID NOT WISH TO BE TRANSPORTED AT THIS TIME. PT WAS INFORMED OF THE CONDITIONS OF REFUSAL AND THAT NOT SEEKING FURTHER MEDICAL TREATMENT COULD BE DETRIMENTAL TO HER HEALTH, UP TO AND INCLUDING DEATH. PT WAS ADVISED SHE COULD CALL 911 ANYTIME IF HER CONDITION CHANGED OR WORSENED. PT STATED SHE UNDERSTOOD AND SIGNED THE PAPER REFUSAL FORM.
33 2021-03-23 hives, itchy skin Patient states about an hour after Pfizer dose #1, she developed itching on back with one hive - las... Read more
Patient states about an hour after Pfizer dose #1, she developed itching on back with one hive - lasted approximately 4 days. Patient estimates the size of hive was around 3cm-5cm. EE states still feels itchy on/off to this day.
33 2021-03-23 rash Per her report she experienced her "throat closing off, vomiting, rash, stomach pain, She went to he... Read more
Per her report she experienced her "throat closing off, vomiting, rash, stomach pain, She went to her doctor on 3/22/2021 and they gave her epinephrine, steroids & antihistamine.
33 2021-03-23 itchy skin, rash Pt states approximately 10 minutes after the shot began having some throat tightness. Slightly hype... Read more
Pt states approximately 10 minutes after the shot began having some throat tightness. Slightly hypertensive, denies fevers, chills, rash, or itching. Pt told staff that she throat was feeling tighter, epi pen was administered and 911 was called. EMS was called and they administered 50 of IV benadryl. Pt was taken to local ED. Upon arrival of ED, pt stated she felt much better, denied any lip/tongue swelling or shortness of breath. Pt was observed for 2 hours in the ED with no symptoms, pt feeling much better, and was released. Discussion will be had as to whether pt should receive 2nd dose.
33 2021-03-23 injection site pruritus Soreness in my arm for a few days, exhaustion 3 hours after injection, and itchiness around the inje... Read more
Soreness in my arm for a few days, exhaustion 3 hours after injection, and itchiness around the injection site around day 2
33 2021-03-24 injection site hardening, injection site redness, bruising, redness, injection site swelling I got the second shot for Pfizer-BioNTech COVID-19 Vaccine EUA on Monday and immediately started to ... Read more
I got the second shot for Pfizer-BioNTech COVID-19 Vaccine EUA on Monday and immediately started to react on the arm it was injected into. I had redness and some bruising that last almost three weeks after the first one. I got the second one in the same arm and this time I had the same redness at the injection site that immediately started bruising. I also saw a red bump develop 24 hours later just below the injection site and after 48 hours it was a round red bump the size of a tangerine. It?s hard to the touch as if some callus formed under the skin. It?s still there three days later
33 2021-03-24 shingles Shingles right upper back/chest area
33 2021-03-24 cellulitis, injection site warmth, injection site redness Tachycardia the day of vaccination, chills and fatigue. Red Hot skin patch at the injection site 2 d... Read more
Tachycardia the day of vaccination, chills and fatigue. Red Hot skin patch at the injection site 2 days after, suspecting cellulitis -> recommended F/U with PCM or Urgent care.
33 2021-03-25 redness, injection site redness, injection site pruritus, injection site swelling, injection site warmth, itchy rash, skin swelling, skin warm Hello, immediately after the shot I began Having pain in the arm which I expected. On the third day... Read more
Hello, immediately after the shot I began Having pain in the arm which I expected. On the third day after the shot, I began Having red swelling skin , with a rash that was itching and the skin is hot to the touch. I am Now 11 days after the shot and the injection site is still hot to the touch, itching, red and now swollen. I am A bit concerned as I did Not think the reaction would last this long. I also Still have soreness in the arm. I thought the symptoms would decrease , not increase. Can I please Speak with someone on your staff about this please?
33 2021-03-25 itchy skin, hives Hives on elbows, shins, behind ears, itchy skin full body
33 2021-03-26 injection site swelling, injection site redness, injection site pain 3/23/21 - 8:00 pm day of 2nd dose started fever, chills, body aches, dizziness, nausea, malaise, and... Read more
3/23/21 - 8:00 pm day of 2nd dose started fever, chills, body aches, dizziness, nausea, malaise, and headache. Dizziness was worst while standing, could not walk far distances or stay upright very long. Fever went as high as 102.5. Took ibuprofen as directed for fever,/pain, but fever still stayed in the 100-101 range until the morning of 3/26/21. 3/27/21 - currently injection site is red, swollen, and painful to the touch. Malaise still lingering
33 2021-03-26 skin discolouration, itchy skin, redness I developed ?covid toes? within 12 hours of vaccine administration. Initially, I experienced pruriti... Read more
I developed ?covid toes? within 12 hours of vaccine administration. Initially, I experienced pruritis in 3 of my 5 digits on the left foot. This progressed to erythema but then transitioned to significant discomfort and the three effected toes became purple in color. This took nearly 6 weeks to resolve.
33 2021-03-27 rash 25 min after shot, my tongue swelled up and mouth was numb for 5 min. Next morning my tongue is stil... Read more
25 min after shot, my tongue swelled up and mouth was numb for 5 min. Next morning my tongue is still swollen and itchy and little rash on my chin.
33 2021-03-27 itchy skin, hives, rash macular 4 days after my first Pfizer dose I got two hives on my right thigh which I thought were mosquito bi... Read more
4 days after my first Pfizer dose I got two hives on my right thigh which I thought were mosquito bites. The next day I had several more hives now on both of my legs, ankle, and toes. I took benadryl through Sunday and the hives seemed to go away. On that Monday March 14 I had new hives, this time on my left hand and right arm near by elbow. I took pictures of my hives as well if anyone needs them. At this point I made a telehealth appointment with my doctor. She looked at them and said they were mild, and I should be ok to take the second shot. She prescribed me an epipen to take with me just in case. She told me to take Claritin during the day and benadryl at night. Since then most of the hives have gone away, but I am still waking up with one or two new ones every day, in different places. Today there is a hive on my right thigh and left knee, both small but itchy. The hives are small, the size of a quarter or smaller. They are red, initially they look swollen and are really itchy. Then they flatten out to be red and kind of splotchy, not as round as when they first form. They are super itchy. Then they fade away very slowly. I still have marks from the first hives on March 12. I've never had allergies or hives like this in my life before the vaccine.
33 2021-03-28 itchy skin, redness I became very itchy, my face reddened, my left ear swelled, and it felt puffy under my left eye. It... Read more
I became very itchy, my face reddened, my left ear swelled, and it felt puffy under my left eye. It went away after about 7 hours
33 2021-04-15 injection site pain Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; severe ... Read more
Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; severe nausea; pain down from injection site; pain down from injection site to in between 3rd and 4th fingers; pain also moving up into neck and upper spine that began; Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; This spontaneous report from a contactable Nurse (Patient). A 33-year-old female patient (non-pregnant) received second dose BNT162B2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration, administered in Right arm on 02Feb2021 07:30 AM for COVID-19 immunisation. The patient medical history not reported. Concomitant medications included ibuprofen (The patient received ibuprofen within 2 weeks of vaccination). There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient received first dose of BNT162B2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL5249), via an unspecified route of administration, administered in Right arm on 12 Jan 2021 09:00 AM for COVID-19 immunisation. On 02Feb2021, 9:30PM, the patient had neck pain stemmed from injection site approximately 14h post vaccination, along with severe nausea. 24h post vaccination whiplash like neck pain that lasted approximately 24h. Neck tenderness persisted, although not severe after 24H. "Tingly" pain down from injection site to in between 3rd and 4th fingers, pain also moving up into neck and upper spine that began about 4 days post vaccination. Unable to get relief with Tylenol, Motrin or muscle relaxers. At the time of this report event outcome was not recovered.
33 2021-04-22 hardening After I received my first dose I started to experience my first symptom on March 30, 2021. I noticed... Read more
After I received my first dose I started to experience my first symptom on March 30, 2021. I noticed that I had a small lump on the left side of my rib cage beside my left breast which was about the size of a sausage link. The area wasn't painful, slightly tender to the touch and soft. By 4/3/21 the area has expanded to the upper portion of the scapula and it was no longer located on the side of my rib. It was about the size a pear and it was inflamed and very tender to the touch. I couldn't raise my arm and it was pertruding from my clothing and preventing me from sleeping at night on that side. By 4/5/21 the mass had turned into a different shape and direction and it was no longer just primarily on my scapula.. This current shape favored a boomerang and it started on my lower scapula and wrapped around my arm going directly into the middle of my arm pit.. It was about an 1.5 inches wide, inflamed, painful and wouldn't allow me to fully lift my arm or lay on it.. The mass was hard and didn't move, I visited a prompt care and they couldn't decipher what it was. I began to take tylenol and use cold compress and over a few days the mass began to decrease in size and I was able to increase my range of motion obtaining full extension on 4/17/21. The mass is now smaller than a pencil on 4/22/21 and hardly noticable but it was quite an experience.
33 2021-04-22 hives, itchy skin Patient had reaction after second dose of Pfizer- hives, pruritus, facial swelling, and swelling of ... Read more
Patient had reaction after second dose of Pfizer- hives, pruritus, facial swelling, and swelling of the lips. Benadryl given and Epi given by EMS. Transported to ED and given Decadron in ED. Monitored for several hours and D/C'ed under stable condition.
33 2021-04-24 skin spots, bruising, skin swelling platelets were tested and had dropped from 296 in Fe to 18 by 01Apr; sick; inflammation response whe... Read more
platelets were tested and had dropped from 296 in Fe to 18 by 01Apr; sick; inflammation response wherein all of new/ old scars swelled up and looked fresh (including an old bee sting, csection scar, etc).; inflammation response wherein all of new/ old scars swelled up and looked fresh (including an old bee sting, csection scar, etc).; petichiae; badly bruising; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient (not pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Mar2021 09:45 at the age of 33-year-old (Lot Number: EM6203) as single dose for covid-19 immunisation. Medical history included ulcerative colitis (remission), beta thal minor, allergies to aspirin and humira; Idiopathic thrombocytopenic purpura (ITP), delivery on28Jan2021. The patient had ITP during pregnancy (delivered 28Jan2021) and had been well in the normal platelet range at/after delivery. Concomitant medications included vedolizumab (ENTYVIO) taken for colitis ulcerative; folic acid; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication on 30Jan2021. The patient previously received the dose 1 bnt162b2 (Lot number: em9809) for covid-19 immunisation on 08Feb2021 09:30 AM. When the patient had the second dose (01Mar2021), she had an inflammation response wherein all of new/old scars swelled up and looked fresh (including an old bee sting, csection scar, etc). The patient also started badly bruising and having petichiae on 01Mar2021. Her platelets were tested and had dropped from 296 in Feb2021 to 18 by 01Apr2021, it continued to drop. This was the lowest they have ever been. She've been very sick on and off since having the second dose (01Mar2021) and recently finished high dose steroid treatment. The adverse event resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of events and included treatment with high dose dexamethasone and blood monitoring. The events outcome was not recovered. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
33 2021-04-26 skin tightness, itchy skin, hives, rash Extreme fatigue a couple hours after receive, maybe around 2p. Took a nap for maybe 2 hours, face s... Read more
Extreme fatigue a couple hours after receive, maybe around 2p. Took a nap for maybe 2 hours, face started to feel itchy and tight. Around 8pm I look in the mirror and I notice my face looked a little puffy, and tiny bumps around my nose and mouth. The next morning, around 5am, my eyelids and lips were noticeable swollen and the hives (tiny bumps) were covering my face, it was itchy mostly around my nose and mouth. I took Zyrtec every day for three days. The swelling went down after the second day, the hives (tiny bumps) cleared up around day three, my skin was completely normal after about a week. On April 13, I started to feel fatigued ( same way I did after I got the vaccine on the 3rd), the next morning my eyelid and lips were swollen and hives and itchness returned. I contacted doctor and he suggested taking Allegra 24 during the day and Benadryl at night ) if I?m itchy. He almost prescribed prednisone for 3 days,but only take if my face was still swelling the next day. On the 14th, my face was still swelling so I started the prednisone. It took about 4 days for my face to clear up completely
33 2021-05-12 itchy rash This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old non-pregna... Read more
This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in left arm on 06Feb2021 at 14:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's disease, hypertension, known allergies: Food allergies (known allergies: Banana, kiwi), known allergies: Histamine reaction. Concomitant medications included levothyroxine, cetirizine hydrochloride (CETRIZINE), ergocalciferol (VITAMIN D), iodine (KELP), metopro; All drugs were received in two weeks within the vaccination. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that, the patient experienced itchy rash all over body, 2 days after vaccination small pustules, strange tingles on 08Feb2021 at 16:00. No fever. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with IV fluids and medications. The outcome of the events was recovering.
34 2020-12-31 injection site pain I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a... Read more
I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a moderate pounding headache. Around 4:30pm, I noticed minor unilateral scalp, facial and neck numbness on the left side. These symptoms lasted about a week, but slowly improved. Four days after the vaccine I had very tender lymph nodes on the left ear area. Today marks two weeks exactly since I received the vaccine and two days ago I noticed slight increase in numbness on the left cheek again which again, is slowly improving. However, I also wear Invisalign at sometimes notice that I bite my cheek while asleep. I also wear N95 masks four days of the week which are quite tight on the face. The injection site (Left deltoid) was moderately sore for the first few days and still two weeks later has minor soreness the comes and goes.
34 2020-12-31 injection site pain Patient reported one day post immunization moderate body aches, headache, severe throbbing injection... Read more
Patient reported one day post immunization moderate body aches, headache, severe throbbing injection site.
34 2021-01-02 injection site pain, injection site redness, injection site pruritus, injection site bruising Developed injection site redness circular in shape approximately 3cm in diameter the following day a... Read more
Developed injection site redness circular in shape approximately 3cm in diameter the following day after vaccine administered. Redness, itching and pain at site continued for 5 days. Then developed into a bruise, still have visible bruising at site. Used ice packs to area to alleviate itching.
34 2021-01-02 injection site pain Left shoulder/arm muscle soreness Left pectoral muscle soreness Tender, swollen lymph node The pain ... Read more
Left shoulder/arm muscle soreness Left pectoral muscle soreness Tender, swollen lymph node The pain in the Left shoulder and across Left chest is persistent and flares with exertion. Tender, swollen (presumed) lymph node directly under Left collar bone and to the left of sternum, pain persistent when at rest and flares when exerting force with Left arm (lifting/pushing/pulling), pain when taking deep breathes.
34 2021-01-03 injection site pain COVID-19 Vaccine #1 received on 12/29/20 @11:40am- That afternoon, mild soreness @ injection site. 1... Read more
COVID-19 Vaccine #1 received on 12/29/20 @11:40am- That afternoon, mild soreness @ injection site. 12/30/21- moderate pain in upper arm and sharp, stabbing pain in axilla (injection site side). Unable to lift arm straight up due to pain. Evening: Myalgia/joint pain, fatigue, nausea, mild headache. Took Tylenol and Phenergan. 12/31/21- Woke up at 4am with pain in axilla-took tylenol. Moderate pain in upper arm and axilla. Unable to palpate axilla due to pain while at work. Evening: axillary lymphadenopathy noted- walnut sized. Severe myalgia/joint pain, fatigue, nausea, headache, malaise. Took Motrin and Phenergan. Woke up in middle of night with pain in arm/axilla and nausea. took tylenol and zofran. 1/1/21- Worst day of symptoms. Moderate-severe pain in upper arm and axilla. Golf ball sized lymphadenopathy in axilla on injection side. Severe weakness, dizziness, fatigue, myalgia, and joint pain. Low grade temp (99.7), tachycardia (HR averaged 110-115), shortness of breath on exertion with associated tachypnea (RR 24-26). No appetite and nausea. Stayed in bed ALL DAY. Alternated Tylenol/ Motrin, Benadryl & Zofran as needed. Only reason I did not go to ED is because I had a pulse oximeter at home was monitoring O2 sats closely. Never de-sat'ed. Had I not had the pulse ox at home, I would've gone to ED. In the evening, had lymphadenopathy in neck also (same side as injection). 1/2/21- Most symptoms have dissipated except axillary lymphadenoapthy- axilla incredibly tender-golf ball sized. Lymph nodes in neck still palpably enlarged. 1/3/21- Lymph nodes in neck normal. Axillary lymphadenopathy remains with same tenderness. 1/4/21 AM- NO change in axillary lymphadenopathy-tenderness same
34 2021-01-03 injection site warmth Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her... Read more
Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her upper chest and arms/ heavy legs and arms/really heavy arms and legs; experienced a weird heaviness on her upper chest and arms; really cold hands; felt really hot at the injection site/really hot sensation at injection site; lightheadedness/Light-headed; Palpitations; Feeling faint; shortness of breath; Her blood pressure went up to 134/100; paleness; went up to her face; felt tired/She was really tired and slept it off; This is a spontaneous report from a contactable nurse, who is also the patient. This 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left deltoid on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included ongoing asthma (diagnosed as a teenager with sports asthma and uses an inhaler). There were no concomitant medications. The patient experienced lightheadedness/light-headed (medically significant) on 20Dec2020 with outcome of recovering, palpitations (medically significant) on 20Dec2020 with outcome of recovered on 20Dec2020, feeling faint (medically significant) on 20Dec2020 with outcome of recovered on 22Dec2020, flushing (medically significant) on 21Dec2020 with outcome of recovered on 22Dec2020, she noticed that there was a ringing in her left ear (medically significant) on 21Dec2020 with outcome of recovering, shortness of breath (medically significant) on 20Dec2020 with outcome of recovering, her blood pressure went up to 134/100 (non-serious) on 20Dec2020 with outcome of recovered on 20Dec2020, she experienced a weird heaviness on her upper chest and arms (non-serious) on 21Dec2020 with outcome of recovering, really cold hands (non-serious) on 21Dec2020 with outcome of not recovered, paleness (non-serious) in Dec2020 with outcome of unknown, felt really hot at the injection site/really hot sensation at injection site (non-serious) on 21Dec2020 with outcome of recovered on 23Dec2020, went up to her face (feeling hot) (non-serious) in Dec2020 with outcome of unknown, heavy legs and arms/really heavy arms and legs (non-serious) on 21Dec2020 with outcome of not recovered and felt tired/she was really tired and slept it off (non-serious) in Dec2020 with outcome of unknown. The patient specified that she experienced a moderate reaction after having the COVID-19 vaccine. She had the vaccine last Sunday morning 20Dec2020. She was told to wait 20 minutes before leaving. In the waiting area, she felt lightheaded, had palpitations and was feeling faint. After 20 minutes she started feeling better. Then she started to have more intense light headedness. She went to the ER and was given oxygen. Her blood pressure was 134/100 on 20Dec2020. She had an EKG on 20Dec2020 that was normal. They gave her steroids and Benadryl. She had another episode while being injected with the steroids. On Monday 21Dec2020, she experienced a weird heaviness of her upper chest and arm. She had really cold hands and flushing. On Monday night 21Dec2020 she went to work. She experienced a really hot sensation to the injection site that went to her neck and face. Her left ear was ringing. This lasted until Tuesday 22Dec2020. She took Benadryl again on Tuesday 22Dec2020. She had shortness of breath which started on 20Dec2020 and on 22Dec2020 she had shortness of breath that lasted until 11am. She had really heavy legs and arms and went back to the ER. She had a chest X-ray and D-dimer on 22Dec2020 that were normal per the ER. The night before the report, she had some of the same symptoms. She was really tired and slept it off. She didn't take anything. The morning of the report, she was feeling good and better. She still has heavy feeling on upper chest and arms. Caller clarifies that she did not have a heavy feeling in her legs. Her arms feel heavy if she holds her phone too long. She continues to have ringing in her ear. The flushing went up to her face. The patient specified that she developed sports asthma as a child and uses an inhaler. She gets short of breath if she overexerts herself. Additional laboratory investigations on 20Dec2020 included blood work with unknown results and Troponin which was normal. She was provided with a general steroid. She did not know the name of it. She was also given Benadryl and monitored on telemetry. She was given IV fluids again on 22Dec2020.; Sender's Comments: Based on the compatible temporal association and the known pattern of response, the Company considers the reported events are possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-03 skin warm, itchy rash, rash with redness On the 16 early in the morning I woke up with a circular, itchy, warm, red rash. I went to Employee... Read more
On the 16 early in the morning I woke up with a circular, itchy, warm, red rash. I went to Employee Health and was prescribed a steroid but I didnt take it and benedryl and claritin. I took claritin and benedryl for about 2 days which began to make the rash subside on the 18 but on the 23rd the rash reappeared and went back to EH and was given another round of steroids which I did in fact take this time. And after the 6th day of the steroid pack the rash has mostly resolved
34 2021-01-04 injection site pain Estimated due date 06/24/2021. I just had arm pain at the injection site and severe headaches for ab... Read more
Estimated due date 06/24/2021. I just had arm pain at the injection site and severe headaches for about 2 days.
34 2021-01-04 vaccination site itchiness, vaccination site warmth, vaccination site pain, vaccination site swelling Right arm swelling; Right arm itching; injection site pain; injection site warm to touch; This is a ... Read more
Right arm swelling; Right arm itching; injection site pain; injection site warm to touch; This is a spontaneous report from a contactable other nurse (patient herself). A 34-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), intramuscularly at site of right arm at 16:00 on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took ciprofloxacin (CIPRO) and experienced allergies: ciprofloxacin. The patient right arm swelling and itching, injection site pain and warm to touch on 23Dec2020. No treatment received for events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was not recovered by day 4 after the vaccination (as reported). Information about Batch/Lot number has been requested.
34 2021-01-04 itchy rash itchy rash on arms; This is a spontaneous report from a non-contactable other-HCP (patient). A 34-ye... Read more
itchy rash on arms; This is a spontaneous report from a non-contactable other-HCP (patient). A 34-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 22Dec2020 10:30 at a single dose for COVID-19 immunization at the hospital. The patient has no medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itchy rash on arms on 25Dec2020 12:00. Outcome of the event was recovering. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received antihistamine for the event. The event was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
34 2021-01-04 itchy rash, hives raised bumps/hives all over body; Generalized Rash that is itchy; This is a spontaneous report from ... Read more
raised bumps/hives all over body; Generalized Rash that is itchy; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received their first dose of BNT162B2 (lot number: ER5730; expiration date unknown), via an unspecified route of administration on the right arm on 20Dec2020 at 11:30 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included amoxicillin. The patient experienced Generalized Rash that is itchy, raised bumps/hives all over body on 27Dec2020. Therapeutic measures were taken as a result of the events which included treatment with hydroxyzine. The patient did not recover from the events.
34 2021-01-05 injection site swelling, injection site pain 12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so... Read more
12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so severe I had a difficult time walking. My injection site (Left deltoid) was swollen and sore, although not more than usual after receiving a vaccine. I had no headache at all. The major concern was the fever and the backaches. I could not get warm, and I was shaking badly because I was so cold. I had ZERO relief despite taking 700 Mg of Tylenol. Side effects finally subsided after about 5 hours.
34 2021-01-05 itchy skin Allergic reaction, shortness of breath, dizziness, itchiness Iv steroids and Benadryl and follow up... Read more
Allergic reaction, shortness of breath, dizziness, itchiness Iv steroids and Benadryl and follow up with pcp
34 2021-01-05 injection site pain At the time of injection, patient felt pain and a "zinger" at the injection site that traveled up in... Read more
At the time of injection, patient felt pain and a "zinger" at the injection site that traveled up into the left shoulder and down the left arm. A numbness and tingling sensation has continued in the left arm and then all over the body- bilateral upper and lower extremities intermittently since time of injection until current. The sensations are occurring randomly about every 1 minute. No associated muscle weakness or any other neurological changes. Patient has been referred to a neurologist for further evaluation and management.
34 2021-01-05 itchy skin Patient's left arm became itchy 5 minutes after receiving vaccine. Given 50mg Benadryl PO, itching ... Read more
Patient's left arm became itchy 5 minutes after receiving vaccine. Given 50mg Benadryl PO, itching spread throughout body but did not progress to hives. Patient declined to be transported to ED for monitoring.
34 2021-01-05 hives, rash Rash; hives; This is a spontaneous report from a contactable other healthcare professional. This oth... Read more
Rash; hives; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unspecified route on 30Dec2020 (at the age of 34 years-old) as a single dose (dose 1) for COVID-19 vaccination. Medical history included metabolic syndrome, tachycardia, interstitial cystitis, anxiety, depression, gastroesophageal reflux (GERD), migraines, polycystic ovarian syndrome (PCOS) and allergy to chocolate, vitamin E and cefaclor (CECLOR). The patient was not pregnant at the time of vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. Concomitant medications included dulaglutide (TRULICITY), metformin, dexlansoprazole (DEXILANT), lamotrigine (LAMICTAL), nitrofurantoin (MACRODANTIN), prazosin, vilazodone hydrochloride (VIBRYD), cefixime (FLEXERIL), ergocalciferol (DRISDOL), topiramate (TOPAMAX) and sumatriptan succinate (IMITREX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 09:30 PM, the patient experienced rash and hives. The report was reported as non-serious. The adverse events rash and hives resulted in physician office visit, emergency room/department or urgent care. The patient was treated for the rash and hives with diphenhydramine (BENADRYL) and prednisone. The clinical outcome of rash and hives was unknown. Since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
34 2021-01-05 vaccination site pain Right arm: Painful; Swollen axilla lymph nodes; tender lymph node; Severe Pain at elbow; This is a s... Read more
Right arm: Painful; Swollen axilla lymph nodes; tender lymph node; Severe Pain at elbow; This is a spontaneous report from a contactable nurse (Patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL0140), via an unspecified route of administration in right arm on 21Dec2020 09:45 at single dose for covid-19 immunization in hospital. The patient's medical history was not reported and there was no known allergies. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient experienced right arm painful, swollen axilla lymph nodes, tender lymph node and severe pain at elbow on 26Dec2020. The events was non-serious. Th events result in Doctor or other healthcare professional office/clinic visit. There was no treatment. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19.
34 2021-01-05 injection site swelling, injection site pain, injection site redness half dollar size swelling at the injection site with mild erythema and tenderness. No treatment need... Read more
half dollar size swelling at the injection site with mild erythema and tenderness. No treatment needed. Swelling and tenderness is going down over time.
34 2021-01-06 rash, itchy skin 1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered t... Read more
1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered taste ~12h 6) No appetite ~48h 7) Fatigue (couldn't stay out of bed) ~24h 8) Nausea, intermittent ~24h 9) Brain fog ~6h 10) Nasal congestion ~72h 11) Full body COVID like rash with itching on 1/2 ~36h 12) Arm sore/stiff (severe) ~24h 13) Vasovagal episode ~10min
34 2021-01-06 injection site redness, bruising, injection site inflammation, injection site warmth Day 1 (1-5-21): sore arm bruise Day 2 (1-6-21): more severe sore arm and bruise Day 3 (1-7-21): sore... Read more
Day 1 (1-5-21): sore arm bruise Day 2 (1-6-21): more severe sore arm and bruise Day 3 (1-7-21): sore arm that's getting better. Red, inflamed, hot to touch at injection site. 1in x 2in in size.
34 2021-01-06 cellulitis Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbea... Read more
Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbearable pain in that arm. Ended up with a trip to the ER with diagnoses of cellulitis to the right arm, (same as vaccinated arm). Currently taking antibiotics.
34 2021-01-06 injection site redness, injection site warmth, injection site swelling, injection site pain Injection site reaction, hot to touch, pain and tenderness, redness, swelling to size of half dollar... Read more
Injection site reaction, hot to touch, pain and tenderness, redness, swelling to size of half dollar Pain lasted approximately 24 hours. Swelling, redness, and heat lasted approximately 30 hours Ice pack to site frequently, Tylenol and ibuprofen twice
34 2021-01-07 rash, shingles, rash with redness Administered on Saturday January 2, 2021. On Tuesday started with some ear pain and lymph node swel... Read more
Administered on Saturday January 2, 2021. On Tuesday started with some ear pain and lymph node swelling. Wednesday much worse lymph node swelling and right side of face with some swelling. Tingling began and bumps with red line formed on forehead. Thursday-same except swelling I'm lymph nodes was so painful it woke me up. Today, Friday January 8th I went to a doctor's care. Diagnosed with shingles.
34 2021-01-07 itchy skin Approx 30 minutes after vaccination, started feeling stomach upset, cramping. Approx 1.5 hours after... Read more
Approx 30 minutes after vaccination, started feeling stomach upset, cramping. Approx 1.5 hours after vaccination, started feeling joint pain. Continued to work until the end of shift 1930. took Benadryl at 32130. Fell asleep; awoke next morning with aches; nasal congestion. Took Sudafed & came to work again (12/18/2020, 0700). Face started itching; then arms @t 0800 but continued working and finished shift. took Benadryl to relieve itching. Awoke early in morning to severe itching. Increased dose of Benadryl and fell asleep. Continued itching on Sat 12/19/2020 and having difficulty breathing. Used inhaler, Pepcid and Prednisone with good effect. Took off work Monday 12/21/2000, Tues 12/22/2020 and Wed 12/23/2020 (no meds taken). Returned to work on 12/24/2020, no fever, no exposure
34 2021-01-07 injection site pain Fever for 20 hours, acetaminophen Myalgias for 48 hours, acetaminophen headache for 24 hours, acetam... Read more
Fever for 20 hours, acetaminophen Myalgias for 48 hours, acetaminophen headache for 24 hours, acetaminophen chills for 24 hours, acetaminophen tenderness at injection site for 48 hours, acetaminophen
34 2021-01-07 vaccination site swelling, vaccination site pain, redness I have a cyst developed on my arm; Injection site is very swollen and very painful; Injection site i... Read more
I have a cyst developed on my arm; Injection site is very swollen and very painful; Injection site is very swollen and very painful; redness on my forearm; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration from 02Jan2021 in the morning (yesterday of 03Jan2021) at single dose for covid-19 immunization. Vaccine location was upper arm and it was the first dose. None medical history. The patient's concomitant medications were not reported. The patient start to develop some redness on her forearm, injecting site is in her upper arm. Patient have a cyst developed on her arm. The cyst, it is on the same arm but on the forearm, it (cyst) was very small like pen tip right now it is like a 2 mm or like 4 mm. She was not sure if it is going to get dissolve or not but it is not recovering for now and it had some yellowish fluid inside the cyst. Patient also stated the injection site was very swollen and very painful. Patient stated she took one Tylenol 400 mg last night and took another one this morning. Patient think she had the lab test for Covid, PCR test within two weeks. The outcome of event "cyst on arm" was not recovered, the other events was unknown.
34 2021-01-07 vaccination site pain, vaccination site redness, vaccination site hardening, vaccination site swelling, vaccination site warmth Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injec... Read more
Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; Left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the left arm on 31Dec2020 at 11:00 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021, the patient experienced left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection. The reporter assessed the events as non-serious. The patient did not receive any treatment for all the events. The patient was not recovered from the events "left upper extremity swelling, induration, sensitivity, redness, heat, and pain at the site of injection."
34 2021-01-07 itchy skin On 1/7/2021, I woke up around 0600. I took Allegra and Sudafed. At 0700, I got the shot; waited 30... Read more
On 1/7/2021, I woke up around 0600. I took Allegra and Sudafed. At 0700, I got the shot; waited 30 min; felt fine and left. At 0745, I started itching and developing a headache (on my drive home). At 0800, restricted breathing; took 50 mg of Benadryl (resolved) and 1000mg acetaminophen for headache (unresolved). At 1200, 99.6 F temp with unresolved headache and felt nausea; took 4mg Zofran. At 1300, took 1000mg acetaminophen; temp was 101 F and stomach felt upset so I didn't want to take ibuprofen At 1900, took 1000mg acetaminophen, temp 100.2F; tried to have some soup; my stomach upset and hurts and feels worse with food At 2200, tempt 99.8 F; stomach hurts; achy; itchy; took 600 mg ibuprofen and 50 mg Benadryl
34 2021-01-07 injection site hardening, injection site pruritus, hives, injection site bruising, injection site redness The next day after shot I developed an induration of site and it became very itchy for 24 hours. Red... Read more
The next day after shot I developed an induration of site and it became very itchy for 24 hours. Red welt stayed in place about half dollar size for 2 days then went away. Then a week later same symptoms developed. And left a bruise from welt and itching. Lasted 2 days
34 2021-01-07 itchy skin Transferred to ED. ED documentation below. Initial Vital Signs [01/06/21 1754] Blood Pressure 146/... Read more
Transferred to ED. ED documentation below. Initial Vital Signs [01/06/21 1754] Blood Pressure 146/97 Heart Rate 78 Respiratory Rate 16 Temp 36.9 °C (98.4 °F) Temp src Oral SpO2 97 % 34 y.o. female who arrived by From on-campus presented to the emergency department for an allergic reaction to the Pfizer COVID-19 vaccine. Pt received the first round of injections at 1707 tonight and experienced adverse reactions. Pt endorses dizziness which is accompanied by central abdominal pain and itching of her left thigh. Pt states that her throat is dry, but adds that it could be from not drinking much fluids today. Pt has a hx of anaphylaxis from shellfish and angioedema. She says these current symptoms are not similar to the ones she experienced from anaphylaxis or angioedema. Pt has not started or changed any medications, but had an IUD inserted about a week and a half ago. Pt denies any fevers, chills, coughs, cold symptoms, chest pain, palpitations, shortness of breath, headaches, nausea, vomiting, bowel or bladder problems, or urinary complaints. Clinical exam shows central abdominal pain just above the umbilicus with itching of the posterior aspect of the left lateral thigh. Will administer PO Prednisone and PO Diphenhydramine in the ED and observe the pt. No epinephrine injection was deemed necessary at this time. DDx: allergic reaction 1910 hours: Discussed further treatment and vaccine advice with the pt. Will discharge pt to home. Provided follow up instructions to her PCP, for reevaluation. Discussed return precautions. Vital signs are stable at time of discharge.
34 2021-01-07 redness, itchy skin employee awoke with throat tightness/soreness, eye swelling, itching and redness. She reports diffi... Read more
employee awoke with throat tightness/soreness, eye swelling, itching and redness. She reports difficulty breathing and felt like her throat was closing. symptoms are 2 days post vaccination. No fever, chills or body aches. sent was sent to the ER.
34 2021-01-07 vaccination site pain heaviness in the arm at the injection site/ left arm is in pain; heaviness in the arm at the injecti... Read more
heaviness in the arm at the injection site/ left arm is in pain; heaviness in the arm at the injection site/ left arm is in pain; This is a spontaneous report from a contactable nurse reported for herself. A 34-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9230 and expiration date: Apr2021), via an unspecified route of administration on left arm on 04Jan2021 at 7:40am at single dose for covid-19 immunisation. The patient medical history included food allergy from 29Jan2020 and ongoing, reported as allergic to avocado, banana, beef, cantaloupe, cashews, chicken, coconut, coffee mix, corn, cucumber, egg, fish mix, green pea, milk, onion, olive, peach, pecan, potato, rice, shrimp, strawberry, watermelon. The patient concomitant medications reported as none. The patient is a registered nurse reporting she got her Pfizer Covid vaccine shot yesterday 04Jan2021 at 7:40 am, she had heaviness in the arm at the injection site on 04Jan2021, clarifies her left arm, she already took Tylenol yesterday. When she woke up this morning, left arm is in pain, the pain will not go away it has been 24 hours. She took her temperature and it is 98.1 F. She does have a lot of food allergies. She attempted to treat the arm pain with acetaminophen, 500mg (expiration Dec2022, purhased from store, Manufacturer is unknown, states it is the generic, LOT P142171). The reporter considered the event as non serious. The outcome of the event was not recovered. .
34 2021-01-07 shingles herpes zoster on the left and mid back in the L1 distribution; This is a spontaneous report from a c... Read more
herpes zoster on the left and mid back in the L1 distribution; This is a spontaneous report from a contactable physician (patient). A 34-year-old non pregnant female patient received bnt162b2 (lot number: EK9231), via an unspecified route of administration on 22Dec2020 in left arm at single dose for Covid-19 immunization. Medical history was none. There were no other medications the patient received within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On unspecified date, the patient experienced herpes zoster on the left and mid back in the L1 distribution. She was not otherwise immunosuppressed and never had zoster before. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with sequel (reported as Recovered with lasting effects). Therapeutic measures were taken as a result of the event which included Valacyclovir. The event was considered as non-serious.
34 2021-01-07 redness increased heart rate, SOB, Tingling, Hot flushed, Red chest, mouth dry
34 2021-01-07 vaccination site pain soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migr... Read more
soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migraine); nausea; general body aches; chills; low grade temp 100; tired; general feeling unwell; This is a spontaneous report from a contactable health care professional nurse, the patient. A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), intramuscular in the left arm on 31Dec2020 16:15 as a single dose, for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing and Know Allergy to Latex. Concomitant medication included budesonide (PULMICORT), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), magnesium (MAGNESIUM), cyanocobalamin (VIT B12). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Jan2021 04:30, the patient experienced soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell. No treatment was given for the event. Laboratory test include Body Temperature 100 on an unspecified date. The clinical outcome of Soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell recovered Jan2021. .
34 2021-01-07 hives, injection site reaction, hives welt on injection site
34 2021-01-08 itchy skin, rash Developed rash on back and chest/stomach approx 19 hours after injection . Itchy all over Eye itch... Read more
Developed rash on back and chest/stomach approx 19 hours after injection . Itchy all over Eye itchiness developed 4 hrs after injection Other symptoms were Muscle and body aches Slight cough Sore throat Face puffy Fatigue Chest heaviness (o2 levels stayed 100 percent )
34 2021-01-08 injection site swelling, injection site redness, injection site pain I have an infection at the injection site. I believe this could happen with any vaccine but wanted t... Read more
I have an infection at the injection site. I believe this could happen with any vaccine but wanted to report just in case. I am experiencing a large circle (a little smaller than a baseball) of swollen red skin that is painful around the injection site. Last night, the lymph nodes in my armpit, neck and collar bone on the right side swelled up and were painful. I feel fatigued.
34 2021-01-08 injection site pain Vaccinated at 610am. Mild myalgias, pain at injection site, and headache starting around around 430p... Read more
Vaccinated at 610am. Mild myalgias, pain at injection site, and headache starting around around 430pm when I woke up for work. Severe myalgias, fatigue, worsening headache, pain at injection site and chills noticed around 9pm on 1/8/21 continued until I went to sleep. I slept from 1am 1/9/21 to 230pm 1/9/21. Currently 4pm and experiencing mild generalized myalgias, mild headache, left shoulder and injection site pain and fatigue.
34 2021-01-08 rash Was being monitored for 15 minutes. About 7 minutes after vaccine a fine rash started on left arm, s... Read more
Was being monitored for 15 minutes. About 7 minutes after vaccine a fine rash started on left arm, spread to chest and other arms. Mild itchiness. No shortness of breath, no lip swelling, no tingling. Self medicated with 50mg Benadryl. I called her 1-9-21 at 9:50am. No rash, no itchiness. No issues at this time. Instructed she may want to pre-medicate or at least bring with her for her 2nd dose.
34 2021-01-09 injection site warmth, injection site redness, injection site hardening, injection site mass, injection site pain 1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible fro... Read more
1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible from technique vs actual vaccine 1807 - Neck pain, 3/10, left arm pain 3/10. Left cervical lymph node inflamed 2035 - ringing on right ear 2244 - dizziness 1/9/21. Injection site 1cm diameter bump. Pain in left arm, neck, shoulder 1156 - headache, sharp right parietal 3/10 1730 - pain 8/10 on left upper arm, radiating to lower arm, shoulder, neck. Improved to 4/10 after Advil 800mg once. 1/10/21. Woke up with pain in left arm 7/10. Injection site has induration of 4cm, reddened, warm, tender to touch. Pain improved after Advil 800mg and Tylenol 500mg
34 2021-01-09 injection site pain 20 hours after injection: Injection site soreness Fever Night sweats Back pain Fatigue Migraine
34 2021-01-09 itchy skin, redness Employee became very itchy on left arm after vaccine administered. Left arm very red. Itchiness spr... Read more
Employee became very itchy on left arm after vaccine administered. Left arm very red. Itchiness spread throughout her body.
34 2021-01-10 skin burning sensation About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feel... Read more
About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feeling warm. Burning sensation followed up to left side of face. Second dose of injection given on left side. Patient states she has a scratchy throat. Vitals taken at 1311: 98.9, 152/98, HR 80, 99% on room air. 50mg IM Benadryl given at 1312 in right deltoid. Laid patient down on stretcher. Patient also stated she developed cold like symptoms after her first Covid vaccine injection, and tested negative for Covid. Vitals rechecked again at 1322: 130/86, 99% on room air, pulse 75. Told patient to say for another 15 minutes in waiting room. Patient left at 1345. Patient stated the burning and warmness had gone away.
34 2021-01-10 injection site redness Fatigue (ongoing), chills (ongoing), muscle aches (1 day), redness at injection site (3 days), short... Read more
Fatigue (ongoing), chills (ongoing), muscle aches (1 day), redness at injection site (3 days), shortness of breath (ongoing)
34 2021-01-10 injection site warmth, injection site pain, injection site swelling I developed a headache about 1 hour after the vaccine was administered. Two hours later I developed... Read more
I developed a headache about 1 hour after the vaccine was administered. Two hours later I developed a 100.4 temperature and malaise and body aches. The injection site was swollen, tender to touch and warm. The injection site area remained tender to touch and I was unable to lie on my left side to sleep for over 48 hours. I continued to feel foggy and fatigued for 48 hours. All symptoms have since resolved.
34 2021-01-10 injection site pain, injection site swelling I developed a headache about 1 hour after the vaccine. I developed a fever of 100.4 about three hour... Read more
I developed a headache about 1 hour after the vaccine. I developed a fever of 100.4 about three hours after my first dose of the COVID-19 shot. Shortly after this I had moderate GI upset including diarrhea, cramping for about 24 hours. Over the course of 48 hours after the vaccine I had swelling at the injection site, tenderness of the injection area to the point where I was not able to put pressure on the area or sleep on my left side and severe fatigue/malaise. All symptoms resolved after 48 hours. I am a person and wanted the reaction information to be part of the trial data.
34 2021-01-10 shingles Shingles
34 2021-01-10 redness Within 45 minutes of receiving the vaccine - red face with tingling; recipient got "extremely warm".... Read more
Within 45 minutes of receiving the vaccine - red face with tingling; recipient got "extremely warm". Resolved quickly once patient received Benadryl 100mg.
34 2021-01-10 redness Within 45 minutes of vaccination - developed red face with tingling; recipient felt "extremely warm"... Read more
Within 45 minutes of vaccination - developed red face with tingling; recipient felt "extremely warm". Patient was medicated with Benadryl 100mg and felt fine after a short period of time.
34 2021-01-10 injection site pain arm pain at site of injection on first vaccine. lasted about 1 week left arm pain at site or inject... Read more
arm pain at site of injection on first vaccine. lasted about 1 week left arm pain at site or injection, severe fatigue, myalgias and low grade fever after second vaccine that lasted for 48 hours
34 2021-01-10 hives, rash, rash with redness rash/hives (deep red) over chest, face, and ear treated with (1) benadryl 50mg capsule
34 2021-01-10 rash, itchy skin rash; All over rash with some itching; This is a spontaneous report from a contactable Nurse reporte... Read more
rash; All over rash with some itching; This is a spontaneous report from a contactable Nurse reported for self. This 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan 2021 12:50 on right arm at single dose (Lot # EK4176, Expiration Date: Mar2021) for covid-19 immunisation. Medical history was not provided. Concomitant medications were none. Past drug history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 16:00 at age of 34 year old at single dose (Lot # EH9899) for covid-19 immunisation. About 30 minutes after being administered (05Jan2021 13:20) that second dose she developed all over rash with some itching. She took Benadryl and Pepcid in response. Today the all over rash with some itching came back at the same persistent level. She wants to know what kind of timeframe she can expect with the continued allergic reaction of all over rash with some itching. She was made to check into the emergency room for observation, but did not have any testing/lab work/investigations done and was not admitted to the hospital. Outcome of the events was not recovered. Reporter seriousness for All over rash with some itching was Medically significant. Drug result was related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Rash and Itching cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-11 itchy skin Feeling of flushing/warmth from head to toe, mild itching throughout body, and dizziness/lightheaded... Read more
Feeling of flushing/warmth from head to toe, mild itching throughout body, and dizziness/lightheaded. Blood pressure was elevated >180/90, HR 110-120. Gradually decreased and at approximately 30minutes post injection, blood pressure was <145/90 and HR 84. Took 25mg of benadryl approximately 1 1/2 hour after injection time. Symptoms persisted mildly for another 30-45 minutes after benadryl and seem to be gone 5 hours later. Blood pressure 5 hours after was 134/85 which is still a slight elevation from my norm.
34 2021-01-11 redness I feel hot after 15-30 minutes of the injection. I turn red and flush. I feel tingling to my legs an... Read more
I feel hot after 15-30 minutes of the injection. I turn red and flush. I feel tingling to my legs and arms. And numbness to the left side of my face. I felt like my heart was beating fast. The administrator gave me bendryl. I felt better, but I felt weak. I was able to go home 2 hours after the administration.
34 2021-01-11 injection site swelling, injection site pain Pain and swelling at injection site, fever, chills, muscle and joint aches, dizziness, weakness, fat... Read more
Pain and swelling at injection site, fever, chills, muscle and joint aches, dizziness, weakness, fatigue
34 2021-01-11 rash Rash on neck; gall bladder attack; This is a spontaneous report from a contactable nurse (patient). ... Read more
Rash on neck; gall bladder attack; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 10:30 at a single dose for COVID-19 immunization in the hospital, and morphine sulfate (manufacturer unknown), via an unspecified route of administration from an unspecified date at unspecified dose and frequency for an unspecified indication. Medical history included S/P rouxen-y gastric bypass, sleep apnea, cholelithiasis, HSV-2, obesity, and Hashimoto hypothyroid disease. The patient was not pregnant at the time of vaccination. Concomitant medications included ursodiol, valacyclovir, levothyroxine sodium (LEVOTH) and vitamins. The patient previously took morphine and experienced allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced Rash on neck, morphine reaction and May or may not be related - gall bladder attack on 18Dec2020 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was administered with NS bolus, diphenhydramine (BENADRYL) and also morphine in response to the events. Since the vaccination, the patient had been tested for COVID-19 via Nasal Swab/COVID-19 rapid ABBT which was negative on 18Dec2020. The action taken in response to the events for morphine sulfate was unknown. The outcome of the events was recovered with sequel. The patient assessed the events as non-serious. Pfizer is a marketing authorization holder of morphine sulfate in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of morphine sulfate has submitted the same report to the regulatory authorities.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-01-12 injection site redness 14 hrs after vaccine developed fever, headache, chills, cough, and severe all over body aches. Mond... Read more
14 hrs after vaccine developed fever, headache, chills, cough, and severe all over body aches. Monday 1/11 through today 1/13 still feeling feverish with chills and body aches but no actual fever and deep dull back pain that is making me vomit. Also injection site redness started 48hrs after vaccine and only continues to worsen and spread each day still today 1/13. Have been taking Tylenol, Motrin, antihistamine, and at times Zofran.
34 2021-01-12 injection site pain 8-10 hours following vaccine: Myalgia throughout body, severe pain at injection site - unable to rai... Read more
8-10 hours following vaccine: Myalgia throughout body, severe pain at injection site - unable to raise arm above shoulder level and painful to move and touch. (resolved) 3 days following vaccine: Sudden onset chills, fever of 101.1, myalgia throughout body and fatigue. I slept for 14 hours straight, still have slight fever of 99.6 and some myalgia, but mostly resolved.
34 2021-01-12 redness After 1st dose : flu like symptoms two days with facial bilateral cheek numbness lasting two weeks ... Read more
After 1st dose : flu like symptoms two days with facial bilateral cheek numbness lasting two weeks After 2nd dose : lightheaded myalgia fever axillary lymph node swelling and redness, nausea, body aches for two days. Still on day four currently : lightheaded/severe dizziness and fatigue
34 2021-01-12 itchy rash, rash, hives First started with lots of muscle soreness of arm where vaccine was placed, a few bumps that were it... Read more
First started with lots of muscle soreness of arm where vaccine was placed, a few bumps that were itchy developed that same afternoon, more bumps appeared next day accompanied by malaise and itching sporadically. By 24 hours, rash and bumps were more prevalent and lots of itching which progressed rapidly through night and hives developed even with antihistamine.
34 2021-01-12 hives Hives to bilateral breasts, self resolved after 3-4 hours (Have bilateral silicone breast implants).... Read more
Hives to bilateral breasts, self resolved after 3-4 hours (Have bilateral silicone breast implants). Patient also had fever, body aches and headache.
34 2021-01-12 itchy skin Itching (Internal) all over within 30 min following vaccination. Took Benadryl
34 2021-01-12 skin burning sensation Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was... Read more
Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was given the vaccine at 0915 today and about 5 mins after started to have symptoms of a hot sensation from head to toe, heart racing, ears burning, and chest tightness, no breathing difficulty. Patient notified staff and was given O2 and allowed to drink her water. Her symptoms did improve and she was sent to the waiting area again. After about 10 mins her chest tightness came back. Patient states she can feel her blood flowing, "kinda like when your limb is numb". Patient also had symptoms of chills, body shakes, loss of smell, and a metallic taste in mouth. Patient states that she was seen again by staff and laid on a cot for 20 mins, and was then cleared to head back to work around 1000. Patient was seen in the clinic at 1157, and her symptoms since it started have improved. Currently she has the following symptoms: can't taste/smell, (L) arm is sore, H/A, with constant ache, localized to back of neck up to behind the both eyes. Body feels worn out, everything feels heavy, takes a few second to focus when she looks around "like there is a delay". Patient was sent home to recover and to let medical staff know if her symptoms return.
34 2021-01-12 itchy skin Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "... Read more
Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "cotton ball" in back of throat, dry mouth; administered Epinephrine 0.3 mg IM x3, solumedrol 125 mg, diphenydramine IV 50 mg and 25 mg, famotidine 20 mg, racemic epi, ativan; reaction started 5 min after dose; discharged with epi pen and prednisone
34 2021-01-12 rash, hives, injection site rash Pfizer-BioNTech COVID-19 Vaccine 5 minutes after receiving vaccine she experienced the following sy... Read more
Pfizer-BioNTech COVID-19 Vaccine 5 minutes after receiving vaccine she experienced the following symptoms: rash/hives (rash on chest, back, around hair line, injection site and behind ears), dizziness, numbness and tingling of tongue. Pt taken to ER as rash and tingling of tongue is persisting after taking Benadryl 50 mg and zyrtec 10mg at 0920. Epipen provided at discharge from ED.
34 2021-01-12 itchy skin Presented itchy in the neck area, torso and arms
34 2021-01-12 rash Systemic: Rash (other than injection site)-Mild
34 2021-01-12 vaccination site pain, vaccination site redness, vaccination site warmth, vaccination site swelling injection site reaction, redness, heat, swelling, pains welling to size of half dollar; injection si... Read more
injection site reaction, redness, heat, swelling, pains welling to size of half dollar; injection site reaction, redness, heat, swelling, painswelling to size of half dollar; injection site reaction, redness, heat, swelling, painswelling to size of half dollar; injection site reaction, redness, heat, swelling, painswelling to size of half dollar; This is a spontaneous report from a contactable Nurse reported for herself. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at Left arm on 28Dec2020 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included binge eating disorder, anxiety. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), escitalopram oxalate (LEXAPRO), buspirone hydrochloride (BUSPAR), cetirizine hydrochloride (ZYRTEC) and birth control medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site reaction, redness, heat, swelling, pain swelling to size of half dollar on 28Dec2020. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
34 2021-01-12 shingles shingles; This is a spontaneous report from a contactable consumer (patient) Pfizer Sponsored Progra... Read more
shingles; This is a spontaneous report from a contactable consumer (patient) Pfizer Sponsored Program. A 34-year-old Female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 at 08:45 at single dose in right arm for COVID-19 immunisation at the age of 34-year-old. Lot number was EJ1685. Medical history included ongoing epilepsy. Concomitant medications included ongoing carbamazepine (TEGRETOL) for epilepsy. On 06Jan2021, the patient had shingles. The consumer was provided with medication, VALTREX and she was informed to take it at 1mg three times a day. The consumer was calling because she needed to know if she could get her second dose as she was scheduled to receive it on 08Jan2021. The patient did not recover from the event. Information on the lot/batch number has been requested.
34 2021-01-13 injection site swelling Body aches, swelling at the injection site, headache, fatigue, and trouble maintaining temperature. ... Read more
Body aches, swelling at the injection site, headache, fatigue, and trouble maintaining temperature. All symptoms subsided within 48 hrs except for the swelling at the injection site.
34 2021-01-13 injection site pain Chills, low grade fever, injection site soreness, fatigue and muscle aches
34 2021-01-13 itchy skin, rash Flushed, itching, rash over arms, trunk, Felt shaky
34 2021-01-13 vaccination site pain Headache; dizziness; body aches; mild fever; chills; extreme fatigue; soreness at injection site; Th... Read more
Headache; dizziness; body aches; mild fever; chills; extreme fatigue; soreness at injection site; This is a spontaneous report from a contactable other HCP (patient). A 34-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 07Jan2021 at 10:45 at single dose in left arm for covid-19 immunization. Medical history included allergies to penicillin. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), levothyroxine, desvenlafaxine succinate (PRISTIQ). The patient previously received the first dose bnt162b2 (Batch/lot number: EK5730) on 17Dec2020 at 15:00 in left arm for COVID-19 immunization at age of 33 years old. The patient experienced headache, dizziness, body aches, mild fever, chills, extreme fatigue, and soreness at injection site on 07Jan2021 at 23:00. All events were reported as non-serious by reporter. The patient didn't receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. The outcome of all the events was resolved in Jan2021. No follow-up attempts are possible. No further information is expected.
34 2021-01-13 skin warm I started experiencing soreness to left arm about 1-2 hours after injection but nothing else. I went... Read more
I started experiencing soreness to left arm about 1-2 hours after injection but nothing else. I went to bed around 11pm. Then I was woken up in the night around 3am violently shaking, teeth shattering and unable to even stand straight from shaking so bad. I felt like I was freezing but skin was hot to touch. I didn't have a thermometer to take temperature at that time because it was in another family member's room. I felt nauseated as well. I took 600mg ibuprofen and tried to lay back down. At 3:59am my aunt woke and brought the thermometer downstairs. I could tell the ibuprofen was working some and fever was less as the shaking had calmed. I was able to check my temperature and it was 100.8F (an hour after the ibuprofen). I still took 100mg tylenol at that time. As of this morning (after 7am) I am sore all over, tired and have a headache, temp 99.2F.
34 2021-01-13 injection site numbness L arm pain and numbness from injection site to shoulder, temp 99.0-99.5 F
34 2021-01-13 rash Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.... Read more
Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Sunday had emergency appendectomy for actuate appendicitis.; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Post surgery had allergic reaction unknown reason with head to toe rash; Post surgery had allergic reaction unknown reason with head to toe rash; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: EL1283) on left arm on 08Jan2021 at 6:30 AM at single dose for covid-19 immunisation. The relevant medical history included celiac, anemia, known allergies: Sulfa and Gluten. Concomitant medications were not reported. The patient received first dose of BNT162B2 via intramuscular (lot number: Ek5730) on left leg on 18Dec2020 at 11:00 AM at single dose for covid-19 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat. On Saturday the patient had sweating, chills, headache, nausea. On Sunday had emergency appendectomy for actuate appendicitis. Post surgery had allergic reaction unknown reason with head to toe rash. It was also reported that the adverse event started on 08Jan2021 at 03: 15 PM (as reported). The patient had 1-day hospitalization. The patient received treatment for the events. The adverse events resulted in Emergency room/department or urgent care. The events were reported as serious due to life threatening and hospitalization. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. Medications administered during appendectomy may confound reactions experienced post-surgery. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-01-13 injection site redness, injection site swelling, vaccination site itchiness armpit swelling; Itchiness, injection site and armpit swelling/It started itching and it is a little... Read more
armpit swelling; Itchiness, injection site and armpit swelling/It started itching and it is a little swollen; It is like the injection site reaction; Redness and swelling around the injection site; Redness and swelling around the injection site; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EJ1685, expiry date: Mar2021) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. Medical history included asthma, anxiety. Concomitant medication included salbutamol (ALBUTEROL) for asthma, venlafaxine hydrochloride (EFFEXOR) for anxiety. The patient had noticed redness and swelling around the injection site. It doesn't seem like an infection but a typical reaction. This happened to the patient on day 8 post vaccination (06Jan2021). She also reported itchiness, injection site and armpit swelling since last night (06Jan2021). She had her vaccine on 29Dec2020 and then the last night (06Jan2021) it started itching and it is a little swollen. It is like the injection site reaction but she did not know it was normal this far after getting it. Like she was just curious that sort of reaction is normal this far after getting the vaccine. Events outcome was unknown.
34 2021-01-14 itchy skin, rash macular Half hour after vaccine complained of itchy chest, shoulders, back, arms, ears and neck. within 1 h... Read more
Half hour after vaccine complained of itchy chest, shoulders, back, arms, ears and neck. within 1 hour you blotchy non-raised rash to chest, front of shoulders, back. Seen in Urgent Care rash traveled down arms. Treated with Zyrtec, Pepcid. At bedtime Benadryl and Zyrtec x 7 addition days. 1/15 doing better, still has rash on neck and arms.
34 2021-01-14 hives Hives began 3:30; facial, hand and lip swelling began 4am
34 2021-01-14 hives Hives that gradually spread over the entire body. Began 12-24 hours after the vaccine was given and... Read more
Hives that gradually spread over the entire body. Began 12-24 hours after the vaccine was given and has progressively gotten worse over the a 2 day period. Was directed to contact PCP for possible treatment
34 2021-01-14 rash macular Lightheaded; Tachycardia; Blotchy rash; This is a spontaneous report from a contactable nurse (patie... Read more
Lightheaded; Tachycardia; Blotchy rash; This is a spontaneous report from a contactable nurse (patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek9231, expiration date was unknown), intramuscularly on the left arm on 08Jan2021 (at 11:00 PM as reported; pending clarification) at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included that the patient had known allergies to medications, food, or other products, but was not specified. Concomitant medications included ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D), curcuma longa (TURMERIC) as supplement, and an unspecified multivitamin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021 (at 11:15 AM as reported; pending clarification), the patient experienced lightheaded, tachycardia, and blotchy rash, which resulted in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of lightheaded, tachycardia, and blotchy rash, which included diphenhydramine (BENADRYL) and steroid. The patient was recovering from all the events.
34 2021-01-14 rash vesicular Patient describes shingles, burning in right side arm into the back and down the arm, rashy blisters... Read more
Patient describes shingles, burning in right side arm into the back and down the arm, rashy blisters on the back and onto arm on the right side.
34 2021-01-14 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA injection site pain, minor nausea, minor headache starting 4 ho... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA injection site pain, minor nausea, minor headache starting 4 hours after vaccine administration injection site pain, fatigue, worsening headache, body aches (muscle pain), chills, worsening nausea starting approximately 30 hours after vaccine administration
34 2021-01-14 redness Reaction started 40min after injection. It started with tingling above the lips and then numbness o... Read more
Reaction started 40min after injection. It started with tingling above the lips and then numbness on the whole face + redness on face and neck per coworker, then collapsed trying to go to the bathroom to look at the redness, then had generalized weakness for about 45 minutes (couldn't move at all or open mouth and eyes). I was finally able to open my eyes 1 hour after it started. Got discharged 2 hours after symptoms resolution. No medication was needed, symptoms gradually faded away.
34 2021-01-14 injection site reaction, redness Tachycardia, Tachypnea, achy joints, feeling febrile but no fever, near syncope, anxiety, redness an... Read more
Tachycardia, Tachypnea, achy joints, feeling febrile but no fever, near syncope, anxiety, redness and hard at injection site 2 days late
34 2021-01-14 injection site pain approximately 3 hours after 2nd dose of vaccine developed body aches, chills, malaise. Next day the... Read more
approximately 3 hours after 2nd dose of vaccine developed body aches, chills, malaise. Next day these symptoms persisted and also developed nausea/stomach ache and mild tachycardia. Chills, injection site pain, malaise
34 2021-01-16 injection site pain Received my second vaccine on 1/13/21 at 10:10am. I felt perfectly fine initially, no soreness in my... Read more
Received my second vaccine on 1/13/21 at 10:10am. I felt perfectly fine initially, no soreness in my arm. By 7 pm my left arm felt sore. By 8 pm I began to have chills, my temp was 98.1 and I had muscle aches. By 10 pm I had a fever of 101.5, chills, muscle weakness, aches, and a headache.
34 2021-01-17 injection site pain 1st day: sore injection site, diffuse joint and bodily pains 2nd day: symptoms from first day conti... Read more
1st day: sore injection site, diffuse joint and bodily pains 2nd day: symptoms from first day continued as well as nausea, fatigue, malaise, fever, chills, blurred vision 3rd day: symptom severity decreased, blurred vision present then resolved. By the fourth day, symptoms resolved.
34 2021-01-17 injection site pain At 1:00 - 3:00 in morning - 100.3 temperature and chills and headache. Headache became severe - 7:00... Read more
At 1:00 - 3:00 in morning - 100.3 temperature and chills and headache. Headache became severe - 7:00 in morning. Really severe joint pain and headache - not quite a migraine - no aura but very severe headache. Had to medicate with 1000 mg Tylenol and 600 of Advil. Headache for days. Pain at injection site and that has been with every vaccine I've ever had. Headache went away within three or four days. Joint pain was there for about two days. Only medicated the headache the first couple of days then it slowly got better. Didn't get vertigo and didn't get flushed after the vaccine. Didn't have the fainting feeling.
34 2021-01-17 redness, skin reaction The nurse that gave the injection said immediately after injecting the medication the patient became... Read more
The nurse that gave the injection said immediately after injecting the medication the patient became anxious, short of breath, stated that her throat felt like it was closing and became red from the face down in all exposed skin that they could see. They called a rapid response and the patient was given epinephrine from an EpiPen. She also took 50 milligrams of Benadryl p.o.. She then was transferred to the emergency department for further evaluation. Upon arrival to the emergency department patient does not have recall of the events just after the injection, she states that she feels that her upper lip is swollen, her throat is swollen and she is short of breath. She seems very anxious and jittery from the epinephrine. Nursing reports that at the scene she was unable to talk, in the Emergency Department she is able to answer questions and speak full sentences. She states that she feels somewhat better on arrival however is not back to baseline.
34 2021-01-17 redness Two hours after vaccine, I felt abdominal pain and felt like I was going to get diarrhea and I got r... Read more
Two hours after vaccine, I felt abdominal pain and felt like I was going to get diarrhea and I got really flushed; shaky; face red. They put ice on back of neck. Arm started to hurt. Took Tylenol and sat down. And felt better 15 minutes later. Intervention was ice on back of neck so I wouldn't faint and rest. Overnight, first night - chills. Woke up with a headache. Took ibuprofen and Tylenol and had body ache and joint pain, too. Five days consistently (positionally) - when I laid down I would get it for five days. I had the vertigo which started 2 days after vaccine. Had a migraine 7 days after vaccine and I had to miss work because it was so severe. Had a typical migraine. Had an aura and it was so bad I couldn't see to drive to work. I don't ever get vertigo with my migraines and so this was different. After 7 days all symptoms were resolved. I am currently breastfeeding.
34 2021-01-18 hives 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nau... Read more
9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
34 2021-01-18 itchy rash Developed and itchy rash on thighs, stomach and upper arms on 1/12/21. Took 24 hour non-drowsy aller... Read more
Developed and itchy rash on thighs, stomach and upper arms on 1/12/21. Took 24 hour non-drowsy allergy medicine for 5 days and rash is gone.
34 2021-01-18 hives Flushed, lightheaded, increased heart rate, hives, shortness of breath
34 2021-01-18 rash macular Numbness in L hand developing 3 hours after the second dose, which occurred while I was asleep and ... Read more
Numbness in L hand developing 3 hours after the second dose, which occurred while I was asleep and then woke up and then went away within 5 minutes. Today, 1/18/2020, I developed dark red blotches on my L hand, especially visible near the knuckles (the metacarpophalangeal joints). It then went away within 3 minutes but then appeared on other parts of my hand, including on my R hand. The blotches all went away within 2-3 minutes but occurred consecutively in different parts of my hand (i.e., some area developed the blotchiness prior to others, and then other parts developed it)
34 2021-01-18 injection site pain Pain at injection site and arm felt heavy for 12 hours.
34 2021-01-18 itchy skin This is a spontaneous report from a contactable other healthcare professional (HCP) (Patient). A 34-... Read more
This is a spontaneous report from a contactable other healthcare professional (HCP) (Patient). A 34-year-old female patient not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 08Jan2021 12:00 PM as a single dose for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Patient had not been tested for COVID-19 post vaccination. On 10Jan2021 09:00 PM patient experienced severe itching that started in lower extremities and has moved up into trunk. Event was treated with diphenhydramine hydrochloride (BENADRYL). Patient was recovering from the event, at the time of the report. Information about Lot/Batch number has been requested.
34 2021-01-19 skin warm, redness Delayed redness, swelling, hot to touch 48+ hours after injection
34 2021-01-19 injection site pain Fever of 103 C, chills, body ache, severe headache, nausea, metallic taste in the mouth 2nd dose of ... Read more
Fever of 103 C, chills, body ache, severe headache, nausea, metallic taste in the mouth 2nd dose of vaccination given at 11 am 1/14/2021. Pain at the injection site . Then body ache started. Midnight 1/14/2021 - chills started, fever 103, severe headache- Fever, body ache and headache continued till Monday(1/18/2021) Strong Metallic taste in the mouth, nausea, dizziness- still continuing.
34 2021-01-19 injection site pain Headache with nausea and vomiting Injection site pain
34 2021-01-19 injection site pain Very sore arm at injection site, headache all day, feeling tired, muscle aches. All of these symptom... Read more
Very sore arm at injection site, headache all day, feeling tired, muscle aches. All of these symptoms lasted for about 12 hours and started about 18 hours after I receiving the vaccine.
34 2021-01-20 injection site redness, itchy skin, injection site rash, redness 1415: Pt reported to staff that she felt lightheaded and that her left arm was itching and felt swol... Read more
1415: Pt reported to staff that she felt lightheaded and that her left arm was itching and felt swollen. Pt BP at that time noted to be 110/88, heart rate 92. Redness and edema moving down left arm noted, pt had some redness/rash around injection site. Denied difficulty breathing or constricted throat. 1420: Pt given 50mg IM Diphenhydramine in right deltoid per DPH Nursing Protocol for allergic reaction. At that time, pt BP 116/90, heart rate 86. 1428: Pt reports decreased itching, BP 120/90, HR 82, respirations 16. 1435: BP 122/80, HR 80, respirations 14. 1442: BP 122/82, HR 78, respirations 16. 1450: BP 112/88, HR 72, respirations 14. Pt discharged from service feeling sleepy, but noted decrease in redness and swelling in left arm. Pt is alert and oriented x 3, pt to have husband come pick her up, no other complaints. Pt reported she is not itching and verbalized that she felt "back to normal."
34 2021-01-20 injection site pain, injection site redness, injection site swelling Injection site is very swollen, red, and tender to the touch.
34 2021-01-20 shingles, redness, skin reaction, itchy rash On 1/16/2020 the patient was noted to have erythema on her hand which she noted was pruritic. She no... Read more
On 1/16/2020 the patient was noted to have erythema on her hand which she noted was pruritic. She noted additional swelling and discomfort and 2 days later area was raised, red/purple and noted as painful and itchy. She sought out help from a physician who noted the area as possible cellulitis and prescribed cephalexin. 2 days later the patient reported to Urgent Care noting more pain and worsening swelling at the site on her Right palm. It was also noted she had a swollen, red lesion on the Right side of her back adjacent to her right scapula. The patient was diagnosed with shingles and was started on Valtrex. Due to timeline and closeness to vaccination dose, consideration of an immune modulated reaction.
34 2021-01-20 hives Patient developed Hives shortly after dose. Reporting on same day of event.
34 2021-01-20 itchy skin Patient received COVID vaccine and was sitting in the monitoring area. She was unable to sit still ... Read more
Patient received COVID vaccine and was sitting in the monitoring area. She was unable to sit still and flagged the RN monitor. She c/o feeling hot, itching, and "scratchy" throat making it "feel funny" to swallow. Strong pulses, patent airway, no hives noted, speaking in full sentences. ED Charge RN contacted and ED RN transported to ED without incident via wheelchair.
34 2021-01-20 redness Pt. noted onset of "numbness", heat and heaviness over her left facial cheek area with a 5X4 inch ar... Read more
Pt. noted onset of "numbness", heat and heaviness over her left facial cheek area with a 5X4 inch area. She denied any difficulty swallowing, no trouble breathing, no associated symptoms, no motor impairments of cranial nerves
34 2021-01-20 vaccination site swelling Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle... Read more
Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; This is a spontaneous report from a contactable Nurse (patient). A 34-years-old female patient received second dose of bnt162b2 (BNT162B2 lot number=EK9231), via an unspecified route of administration on 08Jan2021 08:00 at SINGLE DOSE on arm left for covid-19 immunisation. The patient medical history was none. Known allergies: None. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamin d3 (VITAMIN D3), zinc (ZINC), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and Multivitamins. The patient previous received product=COVID 19, brand=Pfizer, Lot number=EL0140, Administration date=18Dec2020, Administration time=08:15 AM, Vaccine location=Left arm, Dose number=1. On 18Dec2020 04:00 PM patient experienced sudden onset severe muscle aches, joint pain, nausea, lightheaded, fever, cold sweats and fatigue. After the second dose, the patient experienced severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling on 08Jan2021 19:00 with outcome of recovering. No treatment was received. The patient had no covid prior vaccination; no covid tested post vaccination.
34 2021-01-20 injection site pruritus itching at injection site
34 2021-01-21 redness, itchy skin, skin irritation For 3 weeks now I have been having reddish itchy spots on my stomach and ribs and recently mice to m... Read more
For 3 weeks now I have been having reddish itchy spots on my stomach and ribs and recently mice to my lower back. My main concern is the relentless itchiness and irritation. I have attempted to treat this with calamine lotion, tea tree oil and Hydrocortisone to no avail.
34 2021-01-21 redness, skin warm On Tuesday, 11/19 about 10 pm, I started feeling some discomfort in my left breast. The next mornin... Read more
On Tuesday, 11/19 about 10 pm, I started feeling some discomfort in my left breast. The next morning, I was fatigued, had a headache, and woke up with an elevated basal body temperature (I'm normally between 96.0 and 97.5 in the mornings, but ran at 98.2. Not a fever, but enough for me to think it was odd), and some discomfort in my left breast. By the afternoon, part of my breast was red and warm to the touch. My temperature was still in the normal range at 98.7 (I checked since I work in a hospital and wanted to make sure I reported any illness quickly). I went to the ambulatory care center and was diagnosed with mastitis of the left breast and prescribed cephalexin 500 mg capsule QID x10. After 7 doses, I am feeling better and the tenderness, discoloration, and warmth are gone.
34 2021-01-21 hives, redness Redness, flushing, tachycardia and hives within 5-10 minutes of receiving vaccine.
34 2021-01-21 hives, itchy skin The Patient is a 34 year old female. The patient is a 34 yo female with a history of hypothyroidism... Read more
The Patient is a 34 year old female. The patient is a 34 yo female with a history of hypothyroidism who received Pfizer Covid vaccine on 16 DEC (lot #EK5730) after work. She experienced no immediate adverse effects other than about 5 minutes after vaccine receipt she experienced a sensation of ' blood rushed to my ears.' No dizziness or syncope occurred. She had no oral/face/throat/tongue swelling, no urticaria, pruritis, SOB, Wheezing, dypsnea, cough, CP, n/v/d. The following morning she awoke with pruritus to eyes, face, and urticaria to arms, thighs, chest, face and head. She was treated with 8 mgs of decadron and a dose pack. The symptoms abated. The following morning she experienced recurrence which improved with next steroid dose. She took benadryl that night. Symptoms have continued to recur as steroid wanes.
34 2021-01-21 injection site pain, hives The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird... Read more
The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird" in my whole body and lightheaded. I got some juice. Then I started to get hot and was sweating, my whole face and neck were flushed; I also felt mild burning sensation on the R lower lung area. They took me in back and gave me more juice and water and put ice packs on me. It took 30+ minutes to feel better. They called a team to come do my vitals and my HR was in the 100s and they said my eyes were dilated. On my way home I had a weird throbbing pain in my L upper chest just above my boob. When I got home I had chills/felt freezing for a few hours and was fatigued. The next day (Sun) I had moderate joint pain, fatigue, and was very achy; my chest felt tight and I needed my inhaler and some tramadol. On Mon I felt better and went back to work, but then Tues I was achy again and my coworker said I looked pale; I took some tramadol and felt better, just tired. On wed I was having pains in my neck, shoulder, down my arm L arm, and down my scapula- the arm I had the injection. Throughout the day the pain was throbbing and ended up a 7/10 and edema in my neck/shoulder/axillary occurred; I couldnt carry anything heavy and was guarding that arm. Tramadol didn't help the pain and I eventually took 600mg ibuprofen and made a telemedicine visit w/ my MD for the next day. After 3 days the pain was subsiding but the edema took ~ 1 week- it subsided the weekend before my next vaccine. The day of my 2nd dose I did ok after the vaccine at 4pm. While they were injecting it I felt burning down my arm. I felt lightheaded and "weird" afterwards and warm, but no eye dilation or flushing. 3 hours after the vaccine at 7pm I felt tired and a little achy and slept from 7-9pm. At 9pm I woke up very achy, I had 1 itchy hive that popped up on my R inner forearm. The next day I had joint pain in every joint and very achy and fatigued. The joint pain subsided on day 2 after the vaccine but I was very achy and fatigued for a good 72 hrs. Vaccine was wed and saturday the pain in my neck returned and the edema came back and was a little worse than before, and the area where the edema was, was painful to touch. It started subsiding ~ a week after the vaccine, but a little bit is still currently here- but no pain to touch. My allergist has been following up w/ me this whole time.
34 2021-01-22 injection site redness, injection site warmth, injection site pain The evening of the day I got the shot, I began to get tired and started to have a sore arm. Through... Read more
The evening of the day I got the shot, I began to get tired and started to have a sore arm. Throughout the night, the arm soreness got worse and I got joint pain. The whole next day, I experienced severe malaise, headache, chills, fever, and joint pain with the site soreness. The arm pain got worse. That night, I struggled to sleep. The whole day after that, I had less malaise and the fever had gone down but the injection site reddened and grew even warmer and more tender. That evening it was difficult to sleep as the soreness in my arm migrated to the shoulder, armpit and the right side of my chest, along where a bra band would go on the distal right side of the chest. The next morning (today) the entire armpit area and upper distal right side of the chest were hot and tender. This afternoon, I palpated the area and noticed at least one swollen lymph node. My arm still hurts.
34 2021-01-22 itchy skin pt c/o itching on bilateral legs, taken to close observation area where she began to c/o SOB. Epi gi... Read more
pt c/o itching on bilateral legs, taken to close observation area where she began to c/o SOB. Epi given IMx1 and pt transferred to ED
34 2021-01-23 itchy skin, rash My upper back became flushed and a mild rash developed and disappeared about 30 minutes later. I had... Read more
My upper back became flushed and a mild rash developed and disappeared about 30 minutes later. I had small mild rashes on my stomach and back that that lasted until Saturday. My skin felt a bit itchy and prickly in some places.
34 2021-01-23 skin burning sensation Numb tingly mouth, skin felt like it was burned and hurt for anything to touch it, muscle aches and ... Read more
Numb tingly mouth, skin felt like it was burned and hurt for anything to touch it, muscle aches and spasms, headache, nausea, fever, sore arm
34 2021-01-24 injection site pain Fever spike to 102, muscle pain at injection site and all over left side of the body. The fever star... Read more
Fever spike to 102, muscle pain at injection site and all over left side of the body. The fever started at night on 1/21/21 and spiked over 100 around 7am the next day (1/22/21). The fever broke around 5 pm on 1/22/21 after taking Tylenol (2 tablets every 6 hours started around 9am on 1/22). My temperature dropped to 98.9 around 5pm on 1/22; Continued drinking fluids and took another dose of Tylenol before bed at 12:30am. Woke up with no fever the next day (1/23) however muscle pain on the left side of the body is still present.
34 2021-01-24 itchy skin, redness, hives, rash Rash occurred day after on stomach then each day rash would form somewhere else. Itchiness gradually... Read more
Rash occurred day after on stomach then each day rash would form somewhere else. Itchiness gradually worsened each day and rash gradually spreading. Large swollen welt on lower back and past 4 hours progressively increasing in itching and widespread rash over entire back and shoulders. Red swollen welts all throughout with excessive itching. Took levocetirizine and will take 50 mg Benadryl in a few hours. Examined by dermatologist over video and he suggested IM kenalog and antihistamines.
34 2021-01-24 itchy skin, rash with redness Red rash, hypertension, tachycardia. Symptoms resolved and patient was returned to work the next da... Read more
Red rash, hypertension, tachycardia. Symptoms resolved and patient was returned to work the next day. She did have some mild itching for a couple days following the vaccine.
34 2021-01-25 vaccination site pain, vaccination site mass, vaccination site swelling, vaccination site redness Injection site red; Tennis ball sized hard lump; Injection site pain; Injection site Swollen; Facial... Read more
Injection site red; Tennis ball sized hard lump; Injection site pain; Injection site Swollen; Facial pain; Fatigue; Headache; This is a spontaneous report from a contactable other Health Professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), intramuscularly in left arm on 10Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Known allergies: No. Other medical history: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. Other medications in two weeks: No. Facility type vaccine: Hospital. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899) on 20Dec2020 for COVID-19 immunization. The patient experienced injection site pain, swollen, red, tennis ball sized hard lump, fatigue, headache, facial pain, all on 11Jan2021 06:00 with outcome of recovering. No treatment received for all the events. If COVID prior vaccination: No. If COVID tested post vaccination: No.
34 2021-01-25 redness, itchy skin Redness and itchiness
34 2021-01-25 injection site pain Right arm pain and injection site x 3 days, headache, right side body aches x 3 days. Kidney pain x ... Read more
Right arm pain and injection site x 3 days, headache, right side body aches x 3 days. Kidney pain x 2 days.
34 2021-01-26 injection site swelling, injection site redness 25 Jan evening-fatigue, sleepy, injection site red, HA, runny nose 26th Jan 2021-more fatigued, low ... Read more
25 Jan evening-fatigue, sleepy, injection site red, HA, runny nose 26th Jan 2021-more fatigued, low back, hips, legs achy, runny nose, HA 27th January-SAME-nose stopped running, increased fatigue, site of injection-more red/swollen, rt armpit-achy & swollen Treatment-she said she took an aleve this AM-27th Jan, and she will get some PEDILYTE today to sip
34 2021-01-26 itchy skin Felt dizzy fifteen minutes after the injection - at thirty minutes felt better and did not want to g... Read more
Felt dizzy fifteen minutes after the injection - at thirty minutes felt better and did not want to go to ED for evaluation. Came back to vaccine center an hour later and said she felt "itchy all over," and was going to ED for evaluation. No other symptoms reported.
34 2021-01-26 injection site pain Muscle pain at injection site
34 2021-01-27 injection site redness About 48 hours after injection: arm still very sore, red at injection site, and developed swollen a... Read more
About 48 hours after injection: arm still very sore, red at injection site, and developed swollen and sore lymph nodes in right arm (site of injection)
34 2021-01-27 injection site pruritus, injection site redness, injection site rash Body aches, fatigue, headaches and low grade temperature starting about 8 hours after shot and lasti... Read more
Body aches, fatigue, headaches and low grade temperature starting about 8 hours after shot and lasting 36 hours. On day 2, I developed an itchy red large rash at the injection site that lasted 5-6 days then resolved
34 2021-01-27 vaccination site pain Extreme fatigue; Malaise; chills; Injection site pain and tenderness; muscular pain; This is a spont... Read more
Extreme fatigue; Malaise; chills; Injection site pain and tenderness; muscular pain; This is a spontaneous report from a non-contactable physician (reporting for herself). A non-pregnant 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 13Jan2021 6:00 PM at a single dose for COVID-19 immunization. Medical history included: COVID-19 (prior to the vaccine). The patient's concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 24Dec2020 3:00 PM in the left arm, at 34 years old for COVID-19 immunization. The patient experienced extreme fatigue, malaise, chills, injection site pain and tenderness and muscular pain on 14Jan2021. Therapeutic measures were taken as a result of the events which included ibprophen (ADVIL). The outcome o the events was recovered in Jan2021. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
34 2021-01-27 injection site pain Headache, myalgia, fatigue, local site injection soreness
34 2021-01-27 injection site pain Muscle aches on and off all day the day after. Arm sore at sight of injection just the day after.
34 2021-01-27 itchy skin On the day of the vaccination in the afternoon I felt very tired and at times I felt dizzy. The nex... Read more
On the day of the vaccination in the afternoon I felt very tired and at times I felt dizzy. The next day I woke up with an intermittent headache, little bit fatigue, very very tired, my arm was super heavy and I was in bed all day. The third day I felt dizzy at times, tired, my eyes itched a lot and my body. I didn't take any medication at any time.
34 2021-01-28 injection site pain 12 hours post vaccination had chills and body aches, restless sleep. The morning after whioe body so... Read more
12 hours post vaccination had chills and body aches, restless sleep. The morning after whioe body soreness, tired, nauseous, pain at injection site, headache. Took 1000 mg Tylenol at 11 am and 7 pm. Day 2 Body aches, tired. Currently 12 weeks pregnant as of 2nd dose date.
34 2021-01-28 bruising, rash, skin spots 12/24 she lost her voice, developed a cough and SOB, developed rash and bruising. She had fatigue... Read more
12/24 she lost her voice, developed a cough and SOB, developed rash and bruising. She had fatigue, muscle and joint pain. 12/26 She developed generalized petechiae.
34 2021-01-28 injection site pruritus, injection site rash Flu-like symptoms that day, a few days later itchy rash at injection site
34 2021-01-28 injection site pruritus, injection site pain Injection site got sore after just a few moments. Site itched. Began experiencing extreme fatigue. W... Read more
Injection site got sore after just a few moments. Site itched. Began experiencing extreme fatigue. Within the first 15 hours following the injection I began experiencing extreme full body pain, neck, back, arms, legs, hands, and fingers. As well as experiencing a major headache equivalent to migraine pain. The pain was intense and lasted around 36 hours. Pain had subsided within 48 hours excluding pain at injection site that continued but was significantly milder.
34 2021-01-28 injection site pain Received my second dose of Covid vaccine 1/26/21 at 1320. No immediate adverse reaction occurred. I ... Read more
Received my second dose of Covid vaccine 1/26/21 at 1320. No immediate adverse reaction occurred. I started experiencing injection arm soreness around 2100. By midnight I was experiencing chills and body aches. The morning of 1/27 my Temp was 100.0 and I was still having body aches and chills/feeling feverish. This continued throughout the day. I took one dose of Tylenol 1g and later ibuprofen 600mg. The morning of 1/28 I still had a mild headache and temp of 100.00 but overall was feeling much better - no more chills or body aches. My temp prior to going to work that night was 98.6 and my headache had resolved.
34 2021-01-28 injection site hardening, injection site bruising Stiff, sore arm immediately lasting at least 48 hours. Hard and bruised at injection site. Developed... Read more
Stiff, sore arm immediately lasting at least 48 hours. Hard and bruised at injection site. Developed low grade temp, flushed face, fatigue, muscle stiffness, body aches hours following vaccine. Aches and fatigue continues and it?s now day 8. The fatigue is constant but comes in waves. I?m taking unexpected naps which are abnormal for me. Caffeine and methylphenidate are ineffective. I?m still sore. I also have brain fog, maybe from the fatigue. I can?t think straight and it takes me longer to process and do tasks. I woke up 2 hours ago and I can?t wait to sleep again.
34 2021-01-28 redness Swollen armpit- lymph nodes- on left side Swollen chest on left side Swollen left breast Red marks... Read more
Swollen armpit- lymph nodes- on left side Swollen chest on left side Swollen left breast Red marks on chest
34 2021-01-28 rash light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a cont... Read more
light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: El0142), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 (COVID-19 antibody test with positive result) and allergies; Iodine. Concomitant medication included vitamin c [ascorbic acid] and calcium. Both received within two weeks if vaccination. The patient experienced lightheaded, tingling of body and face and rash on right arm on 17Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No treatment received for adverse event. No covid tested post vaccination. The outcome of events was recovering.
34 2021-01-29 skin peeling, pain of skin, skin irritation, rash 1/15/2021: received 2nd dose of vaccine at 5:45 PM 1/16/2021: woke up around 8:00 AM with fever, chi... Read more
1/15/2021: received 2nd dose of vaccine at 5:45 PM 1/16/2021: woke up around 8:00 AM with fever, chills, headache, body aches, fatigue (lasted approx. 24 hours) 1/17/2021: body aches and fatigue continued but improving 1/18/2021: body aches and fatigue continued but improving 1/19/2021: [7:00 AM] facial soreness to the touch, especially along cheekbones 1/20/2021: [7:00 AM] wake up with periorbital edema + face sensitive to touch (felt like pressing a bruise) 1/21/2021: [7:00 AM] face sensitivity improving but periorbital edema progressing + rash under eyes and on eyelids 1/22/2021: dermatitis remains but face sensitivity & periorbital edema improving; go to PCP at 9:30 AM; apply hydrocortisone 2% lotion at PM 1/23/2021: continued improvement; facial skin peeling under eyes; started Zyrtec 10mg in AM; used hydrocortisone 2% lotion at PM 1/24/2021: continued improvement; facial skin peeling under eyes; Zyrtec 10mg in AM; hydrocortisone 2% lotion at PM 1/25/2021: resolved
34 2021-01-30 injection site redness, redness, skin burning sensation, itchy rash, rash with redness, rash, itchy skin, injection site pruritus, injection site pain -Vaccinated 1/28/2021 @10:00am -Experienced burning/itching with slight redness on left deltoid, le... Read more
-Vaccinated 1/28/2021 @10:00am -Experienced burning/itching with slight redness on left deltoid, left side of neck, behind the left ear and down the left shoulder blade @12:00-9:00pm on 1/29/2021 - Woke up on 1/30/2021 with erythematous, pruitic, and non-raised rash on stomach, chest, sides and back. Progressively got more red throughout the day. (Has pictures) - was seen at Urgent Care on 1/30/2021 @ approx. 4:00pm. Given Prednisone 20mg tablets to be taken 3 tablets/day for five days and Benadryl. - woke up on 1/31/2021 with faint rash but greatly improved after antihistamine and steroid dose.
34 2021-01-30 injection site swelling Swollen injection site Swollen arm Largely Swollen lymph nodes Headache Dizziness Inability to lift... Read more
Swollen injection site Swollen arm Largely Swollen lymph nodes Headache Dizziness Inability to lift arm for more than 2 minutes Intense pain to touch Axillary pain
34 2021-01-31 hives, shingles, rash 1-2 days after 2nd dose Pfizer covid vaccine administered, developed significant hives reaction on t... Read more
1-2 days after 2nd dose Pfizer covid vaccine administered, developed significant hives reaction on torso and right leg. Right leg rash biopsied at dermatology visit on 1/21/21 with biopsy results urticarial tissue reaction. Given topical steroid with improvements and started on Zyrtec. Rash finally started improving on Day 11 (1/24/21). Hives rash nearly resolved but then new rash started shortly after on right hip/buttocks. Saw provider in clinic and diagnosed with shingles on 1/28/21. There had been no new changes other than vaccine during time of start of rash (for example no changes in usual lotions, soaps, laundry detergents, new clothing, etc and no new foods had been introduced).
34 2021-01-31 injection site pruritus, injection site hives Hives & Itching around Injection Site
34 2021-01-31 injection site pain Injection Site Pain, Headache, Body ache
34 2021-01-31 injection site pain Injection site soreness (x4 days), loss of left shoulder abduction (x1 day), felt feverish, moderat... Read more
Injection site soreness (x4 days), loss of left shoulder abduction (x1 day), felt feverish, moderate headache, fatigue
34 2021-01-31 injection site pain Injection site soreness (x4 days), moderate headache, fatigue. Headache has been moderate and interm... Read more
Injection site soreness (x4 days), moderate headache, fatigue. Headache has been moderate and intermittent daily since vaccination #2 on 01/19/2021.
34 2021-01-31 injection site pain Migraine (2 days now) - started Ibuprofen as needed Light sensitivity (1 day so far) while working ... Read more
Migraine (2 days now) - started Ibuprofen as needed Light sensitivity (1 day so far) while working from home Fatigue Injection site pain (1 day)
34 2021-01-31 rash Rash on forearms 1 hour following injection that disappeared within 12 hours. Vulvar irritation incl... Read more
Rash on forearms 1 hour following injection that disappeared within 12 hours. Vulvar irritation including lesions noticed roughly 36 hours post injection, lasting for 2 weeks. No interventions or medications used for treatment.
34 2021-01-31 hives allergic reaction with hives up and down her body; allergic reaction with hives up and down her body... Read more
allergic reaction with hives up and down her body; allergic reaction with hives up and down her body/ on her neck, arms, chest, back, buttocks, and down her legs; This is a spontaneous report from a contactable consumer on behalf of his wife. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included blood pressure high diagnosed a month before 18Jan2021 (Dec2020), she had no new medications though. There were no concomitant medications or recent vaccinations. The patient started experiencing an allergic reaction with hives up and down her body on unspecified date in Jan2021, so she sought care from her primary care provider (PCP) who prescribed her steroids (clarified to being prednisolone) methylprednisolone (lot number: 20C0087P, Expiry Date: Mar2022), she was taking 4mg doses as directed by the day, she was on third day of that medication; Benadryl, she had been taking 50mg every 4-6 hours by mouth; Zyrtec (lot number: 120026688, Expiry Date: Aug2022), she had been taking 10mg twice a day by mouth; and Pepcid (lot number: SMF084, Expiry Date: Jul2023), she had been taking 10mg once a day mouth. The reporter says her hives were all over her body: on her neck, arms, chest, back, buttocks, and down her legs. The event outcome was recovered on 18Jan2021, reported as the hives were gone. The only different thing she had recently was the vaccine, so she was concerned about getting the second dose on the 25Jan2021 and she was worried. The reporter said his wife sought help from her PCP along with another provider but they have no answers for them. Information on the batch number has been requested.
34 2021-01-31 injection site pain very painful right arm/injection site. Swelling in armpit of injected arm, looks like a soft egg-s... Read more
very painful right arm/injection site. Swelling in armpit of injected arm, looks like a soft egg-sized lump in right axilla. very swollen and painful right arm. unable to turn arm or hand. cant eat with right hand can't open any door with right extremity because of pain. right forearm in very bad pain. cant even type using right hand.
34 2021-02-01 hives, redness, rash Full body rash, hive like, more on arms, neck and stomach, a little on back and progressed some to l... Read more
Full body rash, hive like, more on arms, neck and stomach, a little on back and progressed some to legs the following day. Would sometimes increase in redness and welting looking appearance.
34 2021-02-01 blister, redness, itchy skin, skin peeling Gradual onset of erythema, pruritus, swelling of my right fourth toe which evolved to swelling of an... Read more
Gradual onset of erythema, pruritus, swelling of my right fourth toe which evolved to swelling of and the same symptoms on my left fourth toe and my left third toe. Additionally some blisters and peeling of the skin. It appears that there is starting to be resolution of my right fourth toe and I assume that I will have resolution of my left toe soon. Visited a podiatrist and the etiology was not known. Awaiting appointment with derm.
34 2021-02-01 shingles Left v1 distribution shingles; This is a spontaneous report from a contactable physician (patient). ... Read more
Left v1 distribution shingles; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: Eh9899) intramuscular on the left arm on 18Dec2020 11:00 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medication included diphenhydramine hydrochloride (BENADRYL), diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) and zolpidem tartrate (AMBIEN). On 21Dec2020 10: 00 AM, the patient experienced left v1 distribution shingles. Therapeutic measures were taken as a result of the event which included valaciclovir (VALTREX) and dexamethasone (DECADRON). Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was recovered on an unspecified date. No follow up attempts are possible. No further information is expected.
34 2021-02-01 rash with redness, itchy skin, rash, rash papular Patient rec'd vaccine and within 5 minutes began feeling hot & itchy. Patient had generalized rash ... Read more
Patient rec'd vaccine and within 5 minutes began feeling hot & itchy. Patient had generalized rash mostly on left cheek, back, and chest. Red & raised. Patient was taken to the ED - vitals were stable, patient was given Benadryl PO and Prednisone 60 mg PO. Pt was observed for a couple of hours and then released.
34 2021-02-01 vaccination site pain, vaccination site itchiness, vaccination site mass, vaccination site redness, vaccination site warmth Poor sleep; Nausea; Fever; Fatigue; headache; pain/soreness all over; itch at injection site; Pain a... Read more
Poor sleep; Nausea; Fever; Fatigue; headache; pain/soreness all over; itch at injection site; Pain at injection site; redness at injection site; Lump at injection site; warm skin at injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1686), via an unspecified route of administration in the right arm on 19Jan2021 at 09:30 AM (at the age of 34-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included HTN (hypertension), depression, ADHD (attention deficit hyperactivity disorder), vitamin D deficiency. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol, clonazepam, escitalopram oxalate (LEXAPRO), pantoprazole, lisdexamfetamine mesilate (VYVANSE), all for unknown indications from unknown dates and unknown if ongoing. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140), via an unspecified route of administration on 29Dec2020 at 09:00 AM (at the age of 34-years-old), in the right arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took and had allergies to atomoxetine hydrochloride (STRATTERA). On 20Jan2021 at 12 AM, the patient experienced poor sleep, nausea, fever, fatigue, headache, pain/soreness all over, itch at injection site, pain at injection site, redness at injection site, lump at injection site, warm skin at injection site. The patient did not receive any treatment for the events. The clinical outcome of poor sleep, nausea, fever, fatigue, headache, pain/soreness all over, itch at injection site, pain at injection site, redness at injection site, lump at injection site, and warm skin at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
34 2021-02-01 shingles, rash, itchy skin Rash on back started Monday January 25. Rash on stomach started Wednesday, January 27. Went to doct... Read more
Rash on back started Monday January 25. Rash on stomach started Wednesday, January 27. Went to doctor Friday, January 29. Pain, rash, itchiness, diagnosed with shingles.
34 2021-02-01 shingles Shingles developed on left arm
34 2021-02-01 injection site pain pain mid arm, 5/10 mid upper arm at the end of deltoid muscle, no bruising and swelling, no increase... Read more
pain mid arm, 5/10 mid upper arm at the end of deltoid muscle, no bruising and swelling, no increase pain with pressure to area; some improvement with warm compress; no change in ROM, no neuropathy
34 2021-02-02 rash At about 2:20 PM , a bystander in the post vaccine observation area noted that patient was becoming... Read more
At about 2:20 PM , a bystander in the post vaccine observation area noted that patient was becoming pale, c/o throat felt like it was closing, felt dizzy, and had a rash beginning on her upper chest. Bystander alerted medical personnel and the patient was eased to ground on a pad and placed in supine position. Oxygen at 3 L via NC started immediately. Initial B/P 145/82, P 80. She was administered 50 mg Benadryl orally at 2:28 pm as her c/o sensation of throat closing was still present. VS at 2:30 pm B/P 105/80. VS 2:34 pm B/P 118/90. She c/o occipital headache 8 out of 10 on pain scale at 2:47--VS B/P 120/78 P 68. At 2:43 pm pulse oximetry 98% P 66. 3:15 pm Paramedics on scene and patient transported via ambulance to ER at Kaiser Hospital.
34 2021-02-03 itchy skin BEGAN ITCHING IMMEDIATELY AFTER VACCINATION THEN LIGHT HEADED AND FELT LIKE THROAT WAS SWELLING
34 2021-02-03 rash with redness Tongue numbness on right side. Mouth feels scalded then moved to feeling like a Novocain injection,... Read more
Tongue numbness on right side. Mouth feels scalded then moved to feeling like a Novocain injection, only one one side. Numbness has moved to middle/back of tongue. Red bumps on tongue.
34 2021-02-04 vaccination site swelling, vaccination site pain Injection site pain; Tiredness; Mild headache; Chills; Muscle pain; Severe joint pain; Injection sit... Read more
Injection site pain; Tiredness; Mild headache; Chills; Muscle pain; Severe joint pain; Injection site swelling; Feeling unwell; Swollen lymph nodes, specifically left underarm area; Shortness of breath; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 16:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. No allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site pain, tiredness, mild headache, muscle pain, chills, severe joint pain, injection site swelling, feeling unwell, swollen lymph nodes, specifically left underarm area, shortness of breath and fast heartbeat on 20Jan2021 14:30. Not received treatment for the adverse events. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Jan2021.
34 2021-02-04 vaccination site itchiness, vaccination site redness Left arm has red itchy mark about the size of a silver dollar where shot was; Left arm has red itchy... Read more
Left arm has red itchy mark about the size of a silver dollar where shot was; Left arm has red itchy mark about the size of a silver dollar where shot was; This is a spontaneous report from a contactable consumer, the patient. This 34-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL0142), dose number 1, via an unspecified route of administration in the left arm on 07Jan2021 at 11:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, sulfa allergy from an unknown date and unknown if ongoing and penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT), unspecified birth control and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 21Jan2021 at 10:00, the patient experienced her left arm has a red, itchy mark about the size of a silver dollar where the shot was. No therapeutic measures were taken as a result of the events. The clinical outcomes of her left arm has a red, itchy mark about the size of a silver dollar where the shot was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
34 2021-02-04 hives Rapid heart rate of 116-120 about 15 min post vaccine. Scratchy throat about 30 min post vaccine. S... Read more
Rapid heart rate of 116-120 about 15 min post vaccine. Scratchy throat about 30 min post vaccine. Sensation of throat closing (lump in throat and getting harder to swallow). My husband dropped me at Emergency room. I was triaged into a room within a few minutes. Started to have a little shortness of breath. Exam performed and 1 liter normal saline given IV. 25mg Benedryl given IV about 3pm. Certirizine HCL 10mg given orally 3:46pm. Prednisone 40mg tab given orally 3:47 pm. Monitored for 4 hours and then discharged home to continue certirizine orally daily for next 2 days along with 40mg pred orally for next 2 days if needed. I took some sunday but not Monday. Did okay with on off hot/cold chills monday and tuesday but now ongoing hives.
34 2021-02-04 rash, itchy skin Rash on my body started to be observed about 28hrs post my 2nd dose of Pfizer COVID-19 vaccine. Rash... Read more
Rash on my body started to be observed about 28hrs post my 2nd dose of Pfizer COVID-19 vaccine. Rash first appeared in the neck area, then gradually migrated to face and lower back around 10pm. I woke up in the middle of the night feeling itchy in my legs and feet. Rashes on my body disappeared when I woke up today (02/05/2021), but my upper eye lids still felt itchy and swollen. Rashes on my upper eye lids faded in the afternoon on 02/05/2021.
34 2021-02-05 hives Hives, burning sensation over skin, pain on roof of mouth.
34 2021-02-06 rash with redness, injection site redness, skin warm, injection site swelling, injection site pruritus Headache, tired, dizziness, red hot rash around neck, nausea, diarrhea, side redness and swelling, s... Read more
Headache, tired, dizziness, red hot rash around neck, nausea, diarrhea, side redness and swelling, site itching Immediately after first dose I had rapid heartbeat, dizziness then fever, nausea, diarrhea, muscle aches, sore arm,
34 2021-02-07 injection site pain, injection site pain Intense chills, uncontrollable shaking & teeth chattering for 2 hours (hours 12-14 after injection),... Read more
Intense chills, uncontrollable shaking & teeth chattering for 2 hours (hours 12-14 after injection), leg aches so great unable to stand. Fever measured up to 100F while on 400mg ibuprofen, temperature not taken during the intense chills. Ongoing fever of around 100F from hours 14 - 24, chills, exhaustion, and general malaise. continued treatment with 400mg ibuprofen. Headache and exhaustion from hours 24 post vaccine through day 5. Ibuprofen and tylenol taken to mitigate symptoms with marginal benefit. Minimal muscle soreness at injection site.
34 2021-02-07 rash with redness, itchy rash, rash Rash, red blotches all over back, abdomen, buttux, chest and neck that itch. Started Friday 2/5 eve... Read more
Rash, red blotches all over back, abdomen, buttux, chest and neck that itch. Started Friday 2/5 evening worsened Saturday 2/6 and has decreased but still showing symptoms through Monday 2/8.
34 2021-02-07 injection site swelling, injection site rash, injection site warmth, rash, skin warm swelling; hot to touch; started lightly at injection site but rash more prominent on sides and back ... Read more
swelling; hot to touch; started lightly at injection site but rash more prominent on sides and back of neck; started lightly at injection site but rash more prominent on sides and back of neck; scratch throat; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown due to not available/provided to reporter at the time of report completion), via an unspecified route of administration in left arm on 20Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included mild hashimotos (no meds, just monitor) and Polycystic ovarian syndrome (PCOS). No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. It was reported that "48 hours" post injection patient developed neck rash, swelling, hot to touch, started lightly at injection site but rash more prominent on sides and back of neck, and scratch throat. All the events resulted in: emergency room/department or urgent care visit. Therapeutic measures were taken as a result of all the events: Steroid and Benadryl injection. The outcome of the events was recovered with lasting effects. The events was considered as non-serious by reporter, as no resulting in death, no life threatening, no causing/prolonging hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.?; Sender's Comments: Causality cannot be excluded for PFIZER-BIONTECH COVID-19 VACCINE and the reported events.
34 2021-02-08 injection site pain Pain at injection site, severe chills, did not sleep much last night, migraine, and body aches on 2/... Read more
Pain at injection site, severe chills, did not sleep much last night, migraine, and body aches on 2/8.
34 2021-02-08 redness Pain from shoulder down to wrist and up the side of neck on arm where vaccine was received. Burning ... Read more
Pain from shoulder down to wrist and up the side of neck on arm where vaccine was received. Burning pain under arm. Swelling under arm and above collarbone and redness on skin in that area. Onset was day after vaccine and improved slowly over next few days. Resolved completely four days later.
34 2021-02-09 hives Hives to face, ears and left arm. Treated with topical steroid and antihistamine. Decrease of hives ... Read more
Hives to face, ears and left arm. Treated with topical steroid and antihistamine. Decrease of hives noted.
34 2021-02-09 vaccination site redness, vaccination site pain, vaccination site swelling Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site swe... Read more
Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site swelling; Injection site redness; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH 9899), via an unspecified route of administration on 21Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included achondroplasia. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 21Dec2020, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, and feeling unwell. Outcome of the events was recovered. The events were considered non-serious.
34 2021-02-09 vaccination site pain Injection site pain; Tiredness; Headache; Nausea; Swollen lymph nodes; This is a spontaneous report ... Read more
Injection site pain; Tiredness; Headache; Nausea; Swollen lymph nodes; This is a spontaneous report from a contactable consumer reported for herself. This 34-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 08:45 AM on Arm right at single dose for covid-19 immunisation. Medical history included Achondroplasia. No allergies to medications, food, or other products. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 09:00 AM on Arm right at single dose (Lot EH 9899) for covid-19 immunisation and experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, injection site swelling, injection site redness, nausea, feeling unwell on 21Dec2020. With second injection: injection site pain, tiredness, headache, nausea, swollen lymph nodes. Outcome of the events was unknown. Information on the lot/batch number has been requested.
34 2021-02-09 rash Systemic: Rash (other than injection site)-Medium; Lasted 4 days
34 2021-02-09 skin spots, rash abdominal pain; rash on legs; Rash continues 1 weeks later with purpura, petechiae with no itching o... Read more
abdominal pain; rash on legs; Rash continues 1 weeks later with purpura, petechiae with no itching or pain; Rash continues 1 weeks later with purpura, petechiae with no itching or pain; This is a spontaneous report from a contactable 34-year-old female nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), via an unspecified route of administration at left arm on 11Jan2021 08:00 AM at single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine administered was hospital. The patient medical history and concomitant medication was none. Historical vaccine included the first dose of BNT162B2 (lot number=EK5730) on 21Dec2020 08:00 AM at left arm for COVID-19 immunization. Not pregnant at the time of vaccination. On 19Jan2021 12:00 AM, the patient developed abdominal pain and rash on legs; rash continued 1 weeks later with purpura and petechiae (Jan2021) with no itching or pain. Doctor or other healthcare professional office/clinic visit was reported. It was reported as non-serious. Unknown if treatment was received for the events. Outcome of events was not recovered. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
34 2021-02-09 vaccination site pain body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, an... Read more
body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); hot and cold flashes; hot and cold flashes; light runny nose (light, yellowish/green); extreme fatigue; inability to concentrate; loss of appetite; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration at the left arm on 21Jan2021 at 14:00 (02:00 PM) at single dose for COVID-19 immunization, administered at other facility (as reported). The patient was not pregnant. The patient had no medical history (reported as none). The patient had no COVID prior to vaccination. The patient has no known drug allergies. Concomitant medication included tocopherol (VITAMIN E), cetirizine hydrochloride (ZYRTEC), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3), and prenatal vitamins. The patient had no other vaccine in four weeks. On 23Jan2021 at 08:00 AM, the patient experienced body aches and weakness, especially in areas that she had previous issues with (low back, ankle, and knee), hot and cold flashes, light runny nose (light, yellowish/green), extreme fatigue, inability to concentrate, loss of appetite, and soreness at injection site. The patient has not been tested for COVID post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.
34 2021-02-10 hives I had an allergic reaction to my renflexis infusion on 12/30/2020 for the first time ever after rece... Read more
I had an allergic reaction to my renflexis infusion on 12/30/2020 for the first time ever after receiving my first COVID vaccine on 12/16/2020. Flushing, chest pressure, tachycardia in the 130?s, tachypneic, dizzy, tingling. I received my second Pfizer vaccine on 1/4 /2021, and had my next renflexis infusion on 2/10/2021, to which I had another allergic reaction despite premeds (hives, urticaria). I?ve been receiving this infusion for well over a year without any issues, and only started reacting since I got the Pfizer vaccine.
34 2021-02-10 redness Patient reported feeling flushed after the vaccine. Vitals below. Benadryl 25mg PO given. BP 110/70... Read more
Patient reported feeling flushed after the vaccine. Vitals below. Benadryl 25mg PO given. BP 110/70 Pulse 100 Noticeably red around the ears and neck, was itchy. Monitored for 20 minutes after Benadryl administration, discharge with father driving
34 2021-02-10 rash, itchy rash, rash with redness Significant red rash on neck and upper chest, with some less noticable rash on upper back and should... Read more
Significant red rash on neck and upper chest, with some less noticable rash on upper back and shoulders/upper arms. Lasting an hour so far, not particularly itchy but I can feel it especially on the left side
34 2021-02-10 rash Starting on 2/2 (about 12 days after my first dose), I developed rashes across my forehead and chest... Read more
Starting on 2/2 (about 12 days after my first dose), I developed rashes across my forehead and chest. I also developed some rashes on my left arm only. Subsequent to my second dose on 2/9 of the vaccine, the rashes started to spread all over my left arm, and some started to develop around my ears, nape of neck and on my right arm. I am not allergic to anything, and have never had a reaction like this. I went to urgent care and they suspected it was vaccine related because of the timing.
34 2021-02-14 redness, itchy skin 0830- Patient reports that her face / upper back and chest are itching. Red spots are appearing on h... Read more
0830- Patient reports that her face / upper back and chest are itching. Red spots are appearing on her chest. No redness on face or back. Also reports itching of palate - no SOB / wheezing. VS - BP 147/81 HR 105 (pt reports that these are elevated from her normal) O2 sat 100% RR20 History of multiple allergies and anaphylaxis (to Humerma). Currently taking prednisone. Has taken Benadryl in the past for allergic reactions. 0832 - Benadryl 25mg PO given 0835 - no increase in sx 0840 - decreasing redness of chest, continued itching of face near hair line 0849 - feeling well, minimal itching. Offered Urgent Care of ER visit... Patient declines both. She is on her way to work and will continue to monitor for any increase in reactive sx. 0850 - left covid observation area by her own decision
34 2021-02-14 injection site warmth, injection site swelling, injection site redness, injection site pruritus ?Covid arm? itching, swelling, redness, warm to the touch at injection site 8-9 days after injection
34 2021-02-14 hives After administering first covid dose, pt. began developing hives across chest and collar bone area. ... Read more
After administering first covid dose, pt. began developing hives across chest and collar bone area. Patient declined shortness of breath, itching, GI upset, difficulty swallowing. Epi-Pen and 9-1-1 offered, patient declined. At this time, pt. stated about 15 years ago developed an idiopathic allergic reaction to an unknown allergen requiring epinephrine administration. The patient stated she does not carry an EpiPen nor does she have one at home. Patient declined 9-1-1 and EpiPen and stated she wanted to remain in observation area for a few more minutes. Patient remained in car in observation area for approximately 20 minutes longer and then choose to return home. At time of departure, patient did not have shortness of breath, GI upset, difficulty swallowing, itching and exited from drive thru site on her own.
34 2021-02-15 itchy rash, rash, rash with redness, rash vesicular After the first vaccine within one week I had covid like symptoms and then devolped a small rash on ... Read more
After the first vaccine within one week I had covid like symptoms and then devolped a small rash on my chest the after my 2nd vaccine thr rash exploded to a full body rash from my neck down. It's itchy red and some blisters.
34 2021-02-15 injection site pain Approx 12 hours after receiving second dose of covid vaccine, I experienced what I can only describe... Read more
Approx 12 hours after receiving second dose of covid vaccine, I experienced what I can only describe as moderate-strong flu symptoms. I had previously had a mild reaction to the first vaccine (fatigue, mild headache) so I was shocked at how incapacitated I was after the second vaccine. 9:00pm (Wednesday) (12 hours after vaccine) - after feeling ok all day, starting to feel sick, chills yet feeling hot (fever at 101.4), muscles and joints aching and headache; 9:00pm-4:00am - very intense flu like symptoms, muscle and joint aching extreme, burning and deep pain on arm at injection site, chills not going away. I eventually fall asleep. 7:00am (Thursday) - call my mother to come pick me up because I am still feeling poorly. Fever is gone but I have a major headache and body aches are persistent. I take Tylenol and some of the body aches are better. I continue to feel like this throughout the entire day off and on. 7:00am (Friday) - finally feeling better but I have a lingering sense of extreme nausea that won't go away. My stomach itself is "fine" but the nausea is persistent. I take dramamine and feel somewhat better. 7:00am (Saturday) - still feeling fatigued but almost feeling like myself again. Nausea is still present but has greatly diminished. 7:00am (Sunday) - finally feeling mostly "ok" again. No noticeable major effects that are interfering with my ability to go about my day.
34 2021-02-15 rash, skin discolouration Contracted/Tested positive for covid19 after receiving 1st dose of vaccine..*1st dose was 1/22/21 **... Read more
Contracted/Tested positive for covid19 after receiving 1st dose of vaccine..*1st dose was 1/22/21 **Tested positive 2/4/21**2nd dose 2/12/21; After second dose, I had rash, discoloration along left leg and painful swelling in left axillary area for 3 days, bad headache, felt ill(chills).
34 2021-02-15 injection site tingling Tingling down arm from injection site. No redness, creepy crawly feeling. Evaluated by EMS 9:42. st... Read more
Tingling down arm from injection site. No redness, creepy crawly feeling. Evaluated by EMS 9:42. stay 15 more minutes. Now lightheaded essential. Had not eaten. Given candy and fruit snack. Feeling better now. Advised to eat somewhere on the way home. Escorted out by MRC. Arm feels the same.
34 2021-02-18 itchy rash Pfizer-BioNTech COVID-19 Vaccine EUA I experienced almost all of the listed potential symptoms afte... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I experienced almost all of the listed potential symptoms after the SECOND shot (fever, chills, headache, nausea, tiredness, muscle pain, feeling unwell), and then also got an intensely itching rash on the inside of my left thigh which gradually got worse and spread up to my vaginal area, skipped across it and started a little bit on the right inside thigh. This was listed as a potential allergic reaction
34 2021-02-18 rash, rash with redness Red, non-pruritic, non-raised rash on chest that spread to the abdomen and trunk. Submitted photos o... Read more
Red, non-pruritic, non-raised rash on chest that spread to the abdomen and trunk. Submitted photos of rash via text message to primary care doctor. Patient spoke on the phone with primary MD after he saw the photos. MD prescribed Prednisone 20 mg daily x 5 days. Rash cleared by day 3 of prednisone course.
34 2021-02-18 itchy skin, hives first had a hard lump in the left arm. 7 days later began to have intensely itchy and painful hives... Read more
first had a hard lump in the left arm. 7 days later began to have intensely itchy and painful hives on extremities, chest, and face with significant edema
34 2021-02-21 injection site swelling, injection site bruising Extreme muscle pain. Twisting and tightening feeling. Unable to relax. swelling at injection site an... Read more
Extreme muscle pain. Twisting and tightening feeling. Unable to relax. swelling at injection site and bruising
34 2021-02-21 injection site pain, injection site reaction Vaccination was at 9:17am. Injection site arm pain and stiffness was noticeable by 12pm, and gradual... Read more
Vaccination was at 9:17am. Injection site arm pain and stiffness was noticeable by 12pm, and gradually worsened to incredibly painful by 8 pm, especially in muscles between left shoulder blade and spine. Chills began around 9:30pm at which point I took one 500mg Tylenol and went to sleep. I woke up with severe chills around 1:45 am and pushed off taking more 500mg Tylenol until 2:45 am. Afterwards I began to feel heartburn and slight nausea but was able to fall back to sleep. I woke up around 3:45 am to vomit. Afterwards, the nausea subsided and I was able to go back to sleep until 6:45am. I woke up with a headache which got worse and I took one Aleve at 9 am. By late afternoon I was feeling much better.
34 2021-02-22 itchy skin, hives, rash 2/16/21 1500 PM received covid vaccine, 2/17/21 at 2200 pm started itching persistently around areas... Read more
2/16/21 1500 PM received covid vaccine, 2/17/21 at 2200 pm started itching persistently around areas where clothing fit tightly along with a rash. Rash started to spread to bilateral shins appearing as welts. Pt. states that she took claritin and called a nurse. Pt. then took benadryl 25 mg po. Pt. then started taking 50 mg of benadryl for worsening rash and itching. Pt. states that itching and rash are still present as of 2/23/2021.
34 2021-02-22 bruising Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizzin... Read more
Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizziness, cannot exercise
34 2021-02-22 injection site pain, injection site warmth, pain of skin On Saturday morning I woke up with a headache and swollen lymph nodes in my neck/collarbone area. As... Read more
On Saturday morning I woke up with a headache and swollen lymph nodes in my neck/collarbone area. As the day progressed, I began to have pain in my joints and muscles. I felt very tired all day as well. I also experienced skin sensitivity which basically just made my skin hurt if anything/one touched me. Sunday my headache persisted, still had pain at injection site and felt warm to the touch. Swollen lymph nodes also still there and fatigue. Monday morning symptoms of headache, injection site pain and warmth and swollen lymph nodes still felt. Taking Tylenol to help with headache, warm compresses to help swollen lymph nodes and ice pack for injection site pain.
34 2021-02-23 itchy skin Received the vaccine, and was in the monitoring area. Within ~5 minutes, I felt my throat was thick... Read more
Received the vaccine, and was in the monitoring area. Within ~5 minutes, I felt my throat was thickening. I asked for water to see if that would help the sensation. The sensation of thickness increased to a tightening and thickness and a very mild itchiness on the roof of my mouth. I continued to feel a strong need to drink water and became extremely cold. At about 20 minutes, my voice became hoarse. I was given benadryl at approximately 40 minutes post injection, however the staff were communicating with people at the ER and was told that I needed an Epipen and to be transported immediately to the ER given signs of analphylaxis with the vocal change. I received the epipen about 45 minutes after injection, and a few minutes after receiving the shot, my throat felt looser. My voice continued to be hoarse. They had a very difficult time finding a vein in my arm for an IV (an I am typically very veiny). I was transported to the ER, and given steriods and monitored. At approximately 4 hrs post vaccine, I started to have worsening voice again, in which they gave me additional benadryl. I continued to be monitored in the ER until 7 hrs post vaccine. My voice continued to have moments where it was better and then it would go away again. They offered to keep me for observation, however I declined and was discharged to home. At home, later that night, I developed entire body itchiness, particularly over my face, and trunk. This lasted for several days, with decreasing intensity. My face was also very flushed looking lasting for 2 days after the reaction. My voice returned to normal after 3 days.
34 2021-02-23 redness, skin warm Red inflamed circle on left arm, about the size of a tennis ball or so with heat, and a knot under t... Read more
Red inflamed circle on left arm, about the size of a tennis ball or so with heat, and a knot under the skin. Given antibiotics, steroid shot, and allergy meds.
34 2021-02-23 redness SOB, Hives, Reddness, Swelling in throat and lips. hoarseness and wheezing
34 2021-02-24 rash, hives, itchy skin Allergic reaction onset 1/18/2021- intense itching noted hives to on my chest and abdomen. Took Diph... Read more
Allergic reaction onset 1/18/2021- intense itching noted hives to on my chest and abdomen. Took Diphenhydramine. Hives increased to larger area to chest, abdomen and thighs. Rash spread to neck, arms, lower legs, then rash spread to my face and soles of my feet.
34 2021-02-24 itchy rash Developed diffuse pruritic rash 1 day after vaccination. Rash has persisted > 1 week. No associated ... Read more
Developed diffuse pruritic rash 1 day after vaccination. Rash has persisted > 1 week. No associated shortness of breath, swelling of lips/tongue/ throat. No further symptoms. Rash improving with benadryl but not resolving.
34 2021-02-24 rash papular, injection site rash, injection site reaction, injection site pruritus I developed a raised, itchy spot at the injection site exactly one week after receiving the vaccine.
34 2021-02-25 itchy skin, rash, skin warm Progress Notes APRN (Nurse Practitioner) -- Family Medicine Cosign Needed Called patient for foll... Read more
Progress Notes APRN (Nurse Practitioner) -- Family Medicine Cosign Needed Called patient for follow up from her visit yesterday here at the vaccine clinic. Pt states she feels well. She did end up taking another benadryl yesterday evening "more out of precautions" rather than for symptoms. She reports she feels well today and has not had any problems. APRN Progress Notes APRN (Nurse Practitioner) -- Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Patient: Date: 2/24/2021 Subjective Patient is a 34 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching and bilateral hand numbness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, stridor, lightheadedness, dizziness, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. She developed more itching later in her visit. Including lip, scalp, ears and ears felt warm. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, malaise/fatigue, facial swelling, ear pain, sneezing, sore throat, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, vomiting, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 1030 02/24/21 1050 BP: 124/67 113/69 Pulse: 75 72 SpO2: 100% 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Head: Comments: Pt noted to itch neck and scalp region Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway No tongue swelling. Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Comments: Injection site w/o erythema or swelling. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Initially with zyrtec, she was not seeing improvement. Two doses of 25 mg of benadryl of 15 minutes within each other, pt was able to see improvement. Pt aware of when she is able to take more benadryl if needed. If symptoms worsen or do not respond to benadryl, pt aware to go to ED. APRN Electronically Signed 2/24/2021 11:14 AM
34 2021-02-25 rash Rash noted in right armpit day following vaccine, spread down the same side of torso, then appeared ... Read more
Rash noted in right armpit day following vaccine, spread down the same side of torso, then appeared in other armpit a few days later. Continued to spread down that second side of torso. Saw partner of my PCP who put me on Doxycycline 100mg BID for 7 days with no change. Saw dermatologist who dx with pityriasis rosea and suggested reporting to VAERS.
34 2021-02-27 redness, injection site pain About 10 minutes after receiving the vaccine, I had chest discomfort followed by the sensation that ... Read more
About 10 minutes after receiving the vaccine, I had chest discomfort followed by the sensation that there was ice around my heart, under my rib cage. The cold heart sensation lasted for roughly 20-30 minutes. Following the start of the cold heart sensation, I became dizzy, sweaty, lost peripheral vision, had numbness in my fourth and fifth fingers (ring and pinky fingers) in both hands, and vaccination site attendant mentioned my hands looked red. Dizziness and other symptoms lasted about 15-20 minutes. Now that over 24 hours have passed, my chest feels a bit tight when I breathe. Injection site is also sore.
34 2021-02-27 rash Bilateral rash with vomiting, tinnitus, neck pain and hot flashes
34 2021-02-27 injection site pain Extreme tiredness, injection site pain, right arm soreness, high fever, body aches, chills
34 2021-02-27 itchy skin Itching. IM benadryl 25mg
34 2021-02-28 vaccination site pain Arm soreness at the site of injection. Not major or debilitating, but noticeable; This is a spontane... Read more
Arm soreness at the site of injection. Not major or debilitating, but noticeable; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date: unknown.), via an unspecified route of administration on the left arm at the age of 34 years old on 04Feb2021 at 15:00 at a single dose for covid-19 immunisation. Patient is not pregnant. Medical history included allergies with sulfa drugs and acne. Concomitant medication included spironolactone for acne. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced arm soreness at the site of injection; not major or debilitating, but noticeable on 04Feb2021 at 16:00. No treatment was received in response to the event. The patient assessed the event as non-serious. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event was recovering.
34 2021-02-28 rash papular, itchy skin Had raised bump on my face, very itchy - occurred 5 hours after getting my 2nd dose of the Pfizer va... Read more
Had raised bump on my face, very itchy - occurred 5 hours after getting my 2nd dose of the Pfizer vaccine. Took a Benadryl and it went away. Since getting the 2nd dose vaccine, I've been having insomnia and would randomly wake up in the middle of the night and not aware of when I fell asleep every night.
34 2021-02-28 injection site pain I have a complicated pregnancy. I was hospitalized on 01-19-2021 at about 10pm. I had repeated blee... Read more
I have a complicated pregnancy. I was hospitalized on 01-19-2021 at about 10pm. I had repeated bleeding episodes. At the hospital they diagnosed me with chronic placental abruption. I delivered my baby by emergency C-section. I also had left arm soreness at the injection site.
34 2021-02-28 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA lethargy, pain at the injection site (began several hours after... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA lethargy, pain at the injection site (began several hours after injection), congestion
34 2021-02-28 itchy skin, rash Received vaccine at 6:15pm on Friday night. Approximately 30 minutes later, my face became very itc... Read more
Received vaccine at 6:15pm on Friday night. Approximately 30 minutes later, my face became very itchy and my face was covered in a red puffy rash. At 8:00pm, I took 25 mg Benadryl. On Saturday, I still had the rash, so I took 3 doses of Benadryl over the course of the day to relieve the rash and itching. The rash resolved Sunday. On Saturday afternoon, I began to develop mild respiratory symptoms as well. My chest became very tight. I took 30mg of prednisone at 4:00pm. This provided relief. The tight chest fully resolved Monday morning.
34 2021-03-01 injection site swelling, injection site pruritus, injection site redness, injection site hardening, injection site warmth Injection received 2/19. On 2/27, my left arm hurt when lifted above shoulder/head. I noticed this ... Read more
Injection received 2/19. On 2/27, my left arm hurt when lifted above shoulder/head. I noticed this when @ the store reaching for an item on top shelf. Once home, I looked at the arm and noticed it was swollen, red, and hot to the touch. Under the skin was also hard. This was all near (estimated) the initial injection site. I circled the area and took 2 Benadryl. The swelling and hardness increased throughout the evening. Placed an ice pack on it and took 2 Tylenol. My temp was 97.7. Next morning (2/28) the swelling had gone down some, but area was still firm and warm to touch. Took 1 Benadryl and 2 Tylenol. Temp was 97.7 again. 3/1 the swelling and heat had greatly diminished but the area was still firm to touch. It also began to itch at this point. Called my PCP and appt. scheduled for 3/2. PCP indicated it was a delayed reaction to the Covid shot and encouraged me to complete this form. As of today, 3/2, the area is much better. Still some firmness but very minimal.
34 2021-03-01 injection site pain sore injection site. no treatment. fever of 100.0 lasting approximately 8 hours. no treatment.
34 2021-03-02 rash macular Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle c... Read more
Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-03-02 injection site pain Fatigue, some muscle weakness in limbs (feels related to fatigue -- arms and legs just feel heavier ... Read more
Fatigue, some muscle weakness in limbs (feels related to fatigue -- arms and legs just feel heavier than usual), muscle soreness in upper arm where injection was placed, neck tension, headache. All of these symptoms started around 4:30PM. As of this report, headache, muscle weakness, and fatigue have resolved. Still have some neck tension (though that is common for me as I work at a computer), and injection site muscle pain is much improved but still noticeable when I move my arm or touch the site.
34 2021-03-02 vaccination site pain, vaccination site mass, vaccination site redness, vaccination site swelling, vaccination site itchiness I had severe soreness for 2 days; I have a half of the dollar size, coin size of bump and it's been ... Read more
I had severe soreness for 2 days; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; I have a half of the dollar size, coin size of bump and it's been red and swollen and itchy; This is a spontaneous report from a contactable pharmacist (patient). A 34-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL9264), via an unspecified route of administration at left deltoid on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient reported that she had her vaccine last Thursday (28Jan2021) and believed she had an injection site reaction. She had severe soreness for 2 days and she had a half of the dollar size, coin size of bump and it's been red, swollen and itchy. She did not take anything for the events because she wanted to see how bad it goes. There was no Physician's Office/Emergency Room visit. She was curious if she will get the second dose since she had this first reaction. The outcome of the events was unknown.
34 2021-03-02 rash papular, redness, injection site pain, itchy skin, skin warm Within 5 minutes of receiving the vaccine my throat became itchy, my sinuses began to swell, a press... Read more
Within 5 minutes of receiving the vaccine my throat became itchy, my sinuses began to swell, a pressure headache began and I became congested. After about 20 minutes my face and lips became numb, my cheeks turned red and hot to the touch, my face started to swell and it felt like my blood pressure dropped, I became dizzy. I took 50mg of Benadryl within 30 minutes of the initial onset of symptoms. All symptoms were gone within an hour of taking the benadryl. Over the next couple hours I experienced discomfort/soreness at the injection site and that tattoo on the same arm as the injection site became raised, hot and itchy. As of 3/3/2021 the only symptom remaining is the soreness at the injection site.
34 2021-03-04 redness First vaccine I could feel the vaccine go into my body and down into my legs. It was a very strange ... Read more
First vaccine I could feel the vaccine go into my body and down into my legs. It was a very strange sensation. I felt very fatigued 30 min after the vaccine but ignored it because it was not normal to have symptoms after the first vaccine. That night i did feel a litlle bit of swelling in my lips that continued into the next day but it was not severe. The muscle aches, joint pain and allodynia the 2nd day were so severe I don't really remember any other symptoms i may have had. I took Benadryl and Tylenol and slept for 2 days straight. After the 1st vaccine I did have shortness of breath for about 3 days post. Then I received the 2nd vaccine, I did not feel it go in this time. About 30 min after the second vaccine I felt very fatigued. About an hour later I started to feel slight swelling in my lips that increased and around 2 1/2 hours my eyes and lips were noticeably swollen and I was flushed. My husband noticed my ears and cheeks were bright red. I felt my heart racing and took my pulse it was around 120. I felt dizzy and like there was a lump in my throat. I requested an appointment via video call from the emergency line. I didn't feel like I was having trouble breathing and stayed calm, my pulse went down to 100 after about 20 min. while waiting for my video call. I spoke to the doctor and they recommended going to the ER. I asked since the pulse went down and it felt like I was slowly reacting, if I could try taking Benadryl and see how I felt. She said that was ok but if I felt any difficulty breathing to go to the ER right away. I took 50 mg of Benadryl and felt better and rested. The next morning lips and eyes were swollen again but a little worse. Difficulty swallowing persisted as well as severe muscle pain, joint pain, and allodynia. The symptoms were worse with 2nd vaccine. Noticed shortness of breath just walking up and down steps. These symptoms lasted a little bit longer. 4 days after the vaccine I noticed the lip swelling was not getting better so I called my PCP. He recommended taking the next 2 days off , rest with benadryl and tylenol. I listened and felt good enough to go into work. It is now 4 weeks since i had the vaccine and i am still experiencing some symptoms that seem to be in relation to after i eat. That includes lip swelling, tightness in the muscles around my throat (feel as if they are strained), stomach burning, indigestion, heartburn. Called PCP again who recommended I see an allergist/immunologist.
34 2021-03-04 hives Hives on chest around 4:40 PM, resolved within the hour.
34 2021-03-06 injection site hives, hives, itchy skin Hives beginning near vaccine site on upper right arm around 8 hours after vaccine, spreading around ... Read more
Hives beginning near vaccine site on upper right arm around 8 hours after vaccine, spreading around upper right arm, right shoulder, left arm, knees. Still experiencing hives 4 days later. Very itchy. Treating with other hydrocortisone and oral benadryl.
34 2021-03-06 itchy skin Throat swelling, itching on site and body, swelling in arm, and around ear in face
34 2021-03-07 hives, itchy skin, skin warm Delayed reaction - large itchy and warm welt, 12 days after second dose
34 2021-03-07 redness Noticed redness in left breast , felt sore around collar bone, was able to express old blood from ni... Read more
Noticed redness in left breast , felt sore around collar bone, was able to express old blood from nipple. Soreness continues, assuming swollen lymph nodes
34 2021-03-07 rash Pt. was being observed for a 30 minute period when on 25 minute mark nurse noticed a rash around the... Read more
Pt. was being observed for a 30 minute period when on 25 minute mark nurse noticed a rash around the client's neck. Vitals where taken and 25 ml of Benadryl was administered. Vitals were within normal parameters. As the rash spread on the client's neck and face, a second dose of 25 ml Benadryl was administered 15 minutes later. Patient was kept in observation for an additional 15 minutes afterwards where redness begin to resolve gradually. Patient was advised not operate heavy machinery and a friend came to the vaccination site and picked up the client. Rash and redness fully resolved by the end of observation period.
34 2021-03-07 injection site pain patient called at around 5:15pm on 3/8/21 reporting that she has developed swelling around her right... Read more
patient called at around 5:15pm on 3/8/21 reporting that she has developed swelling around her right eyes after 1:30pm today (3/8). She received the COVID-19 vaccine yesterday around 10:15am. Patient mentioned that she had some headache and injection site soreness and pain after receving the vaccine, but was fine until today when the swelling appears. She reported no pain with her swollen eyes. Suggested patient to reach out to her PCP or see a doctor in the emergency room.
34 2021-03-08 rash with redness, itchy skin Itchy arm, red rash, appeared more than a week after vaccine. Very very itchy!
34 2021-03-08 injection site pain Pain at injection site. Slight chills. Night sweats with sleep terrors. Slight lymphadenopathy. Slig... Read more
Pain at injection site. Slight chills. Night sweats with sleep terrors. Slight lymphadenopathy. Slight dizziness.
34 2021-03-09 rash, hardening 12hours after injection felt like cold; malaise; bigger rash than first dose; 1 inch induration; Thi... Read more
12hours after injection felt like cold; malaise; bigger rash than first dose; 1 inch induration; This is a spontaneous report from a non-contactable consumer or other non hcp. A 34-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no:EL3246), on Left arm via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot no: EH9899) on Left arm on16Dec2020 for covid-19 immunisation and experienced Rash at injection site, Induration and headache. It was reported that 12hours after injection (Jan2021) of second dose felt like cold, malaise, bigger rash than first dose, 1 inch induration, felt better after 48 hours with Tylenol. There was no COVID prior vaccination and no COVID tested post vaccination. Patient was not pregnant while vaccination. There was no known allergies. Outcome of the events was recovering. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
34 2021-03-09 rash, shingles Developed Shingles shortly after: Skin sensitivity began 3/1/21, severe back pain following 2 days l... Read more
Developed Shingles shortly after: Skin sensitivity began 3/1/21, severe back pain following 2 days later, and rash appeared 3/6/21
34 2021-03-09 vaccination site pain Headache; Slight Fever (100.4 F); Fatigue; Chills; Moderate pain at Injection Site; This is a sponta... Read more
Headache; Slight Fever (100.4 F); Fatigue; Chills; Moderate pain at Injection Site; This is a spontaneous report received from a contactable consumer. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 03Feb2021 15:30 to Left arm at single dose for COVID-19 immunization. Medical history included Shellfish, Tree Nuts (Migraine Trigger). Concomitant medications were not reported. Past drug included BNT162B2 (dose number:1). It was reported as on 04Feb2021 06:30 patient experienced with Slight Fever (100.4 F), Headache, Fatigue, Chills and Moderate pain at Injection Site. Treatment was not received for events. Outcome of events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.
34 2021-03-09 vaccination site rash, vaccination site hardening Rash at injection site and Induration; Rash at injection site and Induration; headache; This is a sp... Read more
Rash at injection site and Induration; Rash at injection site and Induration; headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 34-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EH9899), on Left arm via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot no: EL3246) on Left arm on 06Jan2021 for covid-19 immunisation and experienced 12hours after injection felt like cold, malaise, bigger rash than first dose, 1 inch induration, felt better after 48 hours with Tylenol. It was reported on 16Dec2020 due to first dose patient experienced rash at injection site and Induration, headache that lasted until day 2 after taking Tylenol. There was no COVID prior vaccination and no COVID tested post vaccination. Patient was not pregnant while vaccination. There was no known allergies. Outcome of the events was recovered on unspecified date. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
34 2021-03-09 vaccination site pain The mother was 38 Weeks pregnant at the onset of the event; Chills, aching at injection site, and lo... Read more
The mother was 38 Weeks pregnant at the onset of the event; Chills, aching at injection site, and low grade fever; Chills, aching at injection site, and low grade fever; Chills, aching at injection site, and low grade fever/Highest recorded fever 99.7 degrees F; This is a spontaneous report from a contactable other HCP. A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration from 02Feb2021 14:30 at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient received first dose of BNT162B2 for COVID-19 vaccine on 12Jan2021 at 2:30pm in left arm. The patient's second dose was on 02Feb2021 and the patient was approximately 37 weeks pregnant. That night and the next day, on 04Feb2021 12:45, the patient had chills, aching at injection site, and low grade fever for which the patient took acetaminophen prn (as needed). Highest recorded fever 99.7 degrees F. The mother was 38 Weeks pregnant at the onset of the event. On Feb2021 at 12:50am, the patient's water broke 2.5 weeks before the due date. The patient was admitted to the local hospital and the baby was delivered without complications. Discharged on 05Feb2021. Unsure if early delivery related to vaccination, but thought it worth reporting since there is limited data on pregnant women and the vaccine. The patient underwent lab tests and procedures which included body temperature: low grade fever fahrenheit, body temperature: 99.7 fahrenheit on Highest recorded fever 99.7 degrees F, sars-cov-2 test: negative on 03Feb2021. Treatment was received for the event low grade fever. The outcome of the events was unknown. Information about lot/batch number has been requested.
34 2021-03-11 injection site inflammation, injection site pain Intramuscular injection given improperly. Injected into shoulder joint space. Immediate pain and inf... Read more
Intramuscular injection given improperly. Injected into shoulder joint space. Immediate pain and inflammation at injection site with subsequent significant pain and reduced joint mobility for 96 hours, gradually improving over 2 weeks. Discussed with colleagues and took nsaids for 96 hours to prevent/ treat SIRVA
34 2021-03-11 rash, skin spots Noticed small petechiae rash on right arm, it spread across upper chest area, rash is still present... Read more
Noticed small petechiae rash on right arm, it spread across upper chest area, rash is still present 2 weeks after vaccination. GI symptoms also were noted, 2 weeks of abdominal tenderness, cramping, diarrhea, color change in stools (a lighter yellow color), undigested food also present in stools.
34 2021-03-11 rash Patient came in for first dosage of Covid Vaccine and was identified as high risk related to pregnan... Read more
Patient came in for first dosage of Covid Vaccine and was identified as high risk related to pregnancy. 16 minutes post vaccination patient was transferred into triage area for a rash behind right ear approximately the size of a poker chip. initial vitals taken at 0840 and 50mg of Benadryl administered IM at 0845. Second vitals obtained at 0900 and discharge vitals taken at 0920. Patient is 34 weeks and 5 days pregnant with a EDD of 18 APR 2021
34 2021-03-12 injection site pain After dose 2 - pain at injection site, fever up to 102.5, chills, body aches, fatigue
34 2021-03-12 injection site pain Mild sore arm at injection site few hours after vaccine. Currently pregnant at 37 weeks, 6 days. Est... Read more
Mild sore arm at injection site few hours after vaccine. Currently pregnant at 37 weeks, 6 days. Estimated delivery date is 3/28/2021.
34 2021-03-12 bruising On March 9, 2021 I received my first dose of Pfizer.About 4 hours later I bent my left knee for abou... Read more
On March 9, 2021 I received my first dose of Pfizer.About 4 hours later I bent my left knee for about thirty mins and stood up. I couldn't even put weight on my left leg. My muscles were so tight and strained in my left leg. It felt similar like bruising around my knee and all the way up to my quads. The following day, I rested and iced my leg all day. I couldn't go back to my regular routine of working out until Thursday. However, I was limping until Friday morning. March 13th, my leg is still tight and strained. It hasn't gone back to normal.
34 2021-03-12 redness Very sore arm, red, swollen, fatigue
34 2021-03-14 rash macular, redness 1st injection was given in Quad like my PCP had told them they need to do because of my reactions. ... Read more
1st injection was given in Quad like my PCP had told them they need to do because of my reactions. 2nd injection a RN lead at the clinic told me that I had to get it in my arm or it was not effective, I explained my previous reactions to injections and she stated only to be done in the arm. Last day for 2nd vaccination so I got it. Within the 30 min I told her I had numbness of my top teeth and roof of mouth, let me go back to work after the 30 min. 90 min later I was having red splotches all up and down my arms, 2.5 hours later my throat was starting to each and redness was up and down both arms and chest. ED admission, Pepcid and Benadryl had zero effect, was given a dose of Epi intramuscular in the quad which after 3 min took effect and after 5-7 min all symptoms started clearing up, throat itching and swelling resolved.
34 2021-03-14 hives Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-... Read more
Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot En5318), via an unspecified route of administration, on 05Feb2021 at 01:30 PM (at the age of 34-years-old) as a single dose for COVID-19 immunization, in left arm. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 at 10.45 (lot EL1484, expiry 30Apr2021), for COVID-19 immunization and experienced the onset of headache, intense arm pain at the injection site and mild joint pain. The patient's concomitant medications included The medical history included: Asthma, GERD, and obesity. Allergy to Sulfa. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 (lot E63248), for COVID-19 immunization in left arm. The patient's concomitant medications included ALBUTEROL [SALBUTAMOL]. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021 13:45, she reported experiencing Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back. Patient received treatment of 3 doses of Benadryl. The outcome of the events Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.
34 2021-03-14 rash vesicular, rash, itchy rash Rash appeared on chest, itchy. Within 24 hrs it began to blister. Rash is still present 5 days late... Read more
Rash appeared on chest, itchy. Within 24 hrs it began to blister. Rash is still present 5 days later. Seeping, blister. Chills/sweating. I will go from uncontrollably shaking to a fever. This cycle repeats every 5-6 hrs. This has been on-going for 5 days now. I am unable to care for my infant as I am too weak to walk without feeling like I will pass out. Extreme body aches, my bones and joints are painful to move.
34 2021-03-15 injection site pain 34 female with no previous medical history received 2nd dose of Pfizer vaccine in left deltoid. The ... Read more
34 female with no previous medical history received 2nd dose of Pfizer vaccine in left deltoid. The injection itself was unusually painful and after 10 minutes developed "pins and needles" surrounding naval, and then over the course of 4 days (present) the parasthesias/dysesthesia progressed to include bilateral upper and lower extremities. Today, 4 days post injection, started to notice perioral involvement. It is intermittent, migratory and unpleasant if not painful. Most severe symptoms experienced in right calf, right heel and left finger tips. Exacerbated by use/motion/pressure. Has not attempted any therapeutics to avoid masking progression of symptoms. Primary care physician made aware of.
34 2021-03-15 hives, injection site rash, rash Hives, Rash that began on left arm at vaccination site and spread across chest, to right arm and dow... Read more
Hives, Rash that began on left arm at vaccination site and spread across chest, to right arm and down abdomen, even a bit on upper thighs. Lasted for over a week.
34 2021-03-15 itchy skin itchy across chest and rt. shoulder and back .
34 2021-03-16 itchy skin 09:37 patient received 1 dose of pfizer vaccine ( covid-19). After 5 mins apt ient Started to feel ... Read more
09:37 patient received 1 dose of pfizer vaccine ( covid-19). After 5 mins apt ient Started to feel itching on her arms, back, legs and back of the head 09:55 MD brought the patient to building where she was seen by MD. No shortness of breath, stridor, Patient was given Zyrtec 10 mg PO. 10:00 patient symptoms getting worse. MD notified benadryl 50mg PO given 10:30 BP 143/100 HR 84, RR 20 SpO2 97% RA 10:44 Patient state she feels much better at this time. Denies any itching, SOB, nausea or vomiting
34 2021-03-16 injection site pain Dizziness immediately after vaccine that improved within a few hours. Pain at injection site lasting... Read more
Dizziness immediately after vaccine that improved within a few hours. Pain at injection site lasting 2 days. Joint pain in fingers and hips lasting one week. Body aches starting 3/9 (no fever), still present daily. 5 days late for menstruation, 2 negative pregnancy tests.
34 2021-03-16 rash I had burning pain radiating down my right butt cheek, hip and leg that started on 01/04/2021. A ra... Read more
I had burning pain radiating down my right butt cheek, hip and leg that started on 01/04/2021. A rash errupted on 01/09/2021 that stayed on my hip. I was prescribed Valtrex on 01/10/2021 for one week that haulted the progression of the rash.
34 2021-03-16 rash macular Received vaccine on 3/3/21 at 11:15 AM. Was observed at the clinic for 15 minutes after the dose wa... Read more
Received vaccine on 3/3/21 at 11:15 AM. Was observed at the clinic for 15 minutes after the dose was given. She left the clinic reporting that she felt fine. She states that as she was driving home, that she was not feeling well, and decided to return to the clinic. She returned at 11:45. She reported that her jaw felt tight. She appeared to have flushing in her cheeks. She denied rash or itching, but there appeared to be a few blotchy areas on her upper chest. VS taken, BP ws 122/82, pulse 84, resp rate 16. O2 sat was 98%. She was observed by the nurse and no change in symptoms or vital signs. EMS personnel were on site and after consulting with EMS, administered Benadryl 50 mg IM into R upper arm. She was observed for 30 minutes after Benadryl administered, and symptoms disappeared after the observation period. Recommended that she follow up with her health care provider immediately. She was released from the observation site in good/improved condition.
34 2021-03-16 injection site pain, injection site redness, injection site mass Slightly sore, red lump has formed at injection site
34 2021-03-17 skin warm, hives, rash, itchy skin I got the first COVID vaccine on March 8th. The next day, I had a rash on my chest and thighs that ... Read more
I got the first COVID vaccine on March 8th. The next day, I had a rash on my chest and thighs that became hives. The hives were hot and itchy. This reaction gradually grew worse and the rash spread to the rest of my legs, down my arms, and to my belly. When it started up my neck, I noticed that my throat was getting a bit sore and tight. I called my primary care provider and she told me to go to the ER. The ER providers drew blood, which was normal except for low potassium and elevated red blood cells. They treated me with IV Benadryl and steroids, which caused the symptoms to dissipate quickly. The doctor also prescribed Pepcid and an epipen.
34 2021-03-17 rash, itchy skin Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/18/2021 2:52 PM E... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/18/2021 2:52 PM Expand AllCollapse All COVID VACCINE CLINIC 3/17/2021 Date: 3/17/2021 Subjective Patient is a 34 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience itching. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Medical hx insignificant ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Previous Reactions: same itching with 1st vaccine of Pfizer. Objective Vitals Vitals: 03/17/21 1625 03/17/21 1640 BP: 128/74 124/79 Pulse: 71 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines benadryl and pepcid Follow up response to treatment: fair. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) All over itching. Similar to last time. Pt given benadryl 50 mg and pepcid 20 mg. Pt not drowsy at time of discharge. States she does fine with benadryl. She feels comfortable going home and managing it on her own. States she will seek emergent care if new symptoms arise. Pt wishes to be discharged. Discussed symptoms to monitor for. No progression of symptoms while observed in the bay. APRN Electronically Signed 3/17/2021 5:00 PM
34 2021-03-17 injection site pruritus Recieved vaccine at 10:45. within 5 mins the injection site was itchy and the outer side of upper ar... Read more
Recieved vaccine at 10:45. within 5 mins the injection site was itchy and the outer side of upper arm from the injection point to elbow felt cold. Itching went away within the next 15mins and the cold feeling took closer to 25mins to go away completely. I also experienced a dull achy headache that came on about 10mins after injection. The headache was at the base of my neck and traveled up to the top of my head- in a deep achy way that lasted all day. By the end of the day I was achy and stiff all over. I took one ibuprofin at 9am and another at about 2pm. The next day I woke up extremely stiff and achy, possible low grade fever. Very fatigued, slept for 3 hours in the middle of the day. Next day felt back to normal. thank you.
34 2021-03-18 itchy skin, hives, rash Horrible headache started a few hours after injection with nausea, but backed off by next morning. B... Read more
Horrible headache started a few hours after injection with nausea, but backed off by next morning. By Saturday, the headache was back with the nausea and I began feeling very itchy. When I woke on Sunday, I had hives and a rash all over my face and most of my left side, which is the side I got my shot. Called Dr Monday and was sent to urgent care, who then sent me to the ER. Heart rate was high, hives, rash, headaches, nausea, swollen eyes and face, swollen lymph nodes
34 2021-03-18 redness Sore arm, redness, 10 days after initial first vaccine
34 2021-03-18 skin tightness Sudden facial discomfort on left side of face (pressure, numbness, tingling) and unexpected crying; ... Read more
Sudden facial discomfort on left side of face (pressure, numbness, tingling) and unexpected crying; 24 hours later mostly subsided but still decreased sensation in left side of face and feeling of pressure/tightness in left side of face.
34 2021-03-19 injection site pain Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flus... Read more
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: PT as given the vaccine and waited 15min. during the waiting period she reported she didn't feel too good. her BP was taken every 5min BP was 115/71. 911 was called but she said she was feeling better and wasn't transported with the ambulance
34 2021-03-19 rash patient started feeling dizzy, nauseous, and rash started to develop on her chest. Patient was injec... Read more
patient started feeling dizzy, nauseous, and rash started to develop on her chest. Patient was injected with benadryl IM 50 mg 1ml on her right arm and 911 was called. Five minutes later, patient reported feeling tight on her throat, she was immediately injected with Epipen and help arrived within minutes.
34 2021-03-20 rash, injection site rash Armpit rash in both armpits within 24 hours. Rash was more significant in the arm of the injection. ... Read more
Armpit rash in both armpits within 24 hours. Rash was more significant in the arm of the injection. It was not painful, I didn't notice it was there until looking in the mirror. It was gone by hour 36.
34 2021-03-20 redness Redness and warmth left arm is main symptom along with SOB, light headedness, fatigue, sinus pressur... Read more
Redness and warmth left arm is main symptom along with SOB, light headedness, fatigue, sinus pressure and sore throat
34 2021-03-21 itchy skin, rash macular No pain or adverse event for the first 4 hours after vaccination. Starting at 2pm, which was 4 hours... Read more
No pain or adverse event for the first 4 hours after vaccination. Starting at 2pm, which was 4 hours after my vaccine, , my chest began to tighten. It was not severe; I took a normal walk and was just mildly uncomfortable. It escalated hourly for about 10- 12 hours. At 8pm, the pain, pressure, and tightness around the chest went from mild to moderate, from a pain level of 2 to about 3 or 4. The sensation was one of a stack of books on my chest. There was pressure and mild pain (again, not severe), about 8-10 inches horizontally across my chest, from about the bottom of my sternum to the collarbone. I also felt some pressure in my lower throat, perhaps the bottom third of my neck. I did not have any shortness or breath, swelling, or difficulty swallowing. At about 9 pm, I became itchy on my neck, ankles, and flank. I developed some red spots, which were not large enough to be hives, They mostly became red from my itching, though they were more moderately itchy than seriously itchy. I have had hives before, and they did not appear to be hives, more just isolated red spots. Once I became itchy, I went to the ER. They worked me up for cardiac issues and a blot clot, but all tests were negative. I did not take any medication other than my standard Oxcarbazepine 8pm dose of 300 mg. The itchiness went away at about 11pm (two hours after onset), and the chest pain did not worsen. The following morning, it was significantly better, and about 36 hours after I first received the vaccine, it was gone entirely.
34 2021-03-21 rash, itchy rash, rash with redness Rash down both of my sides that was itchy and painful, onset maybe a couple of hours after administr... Read more
Rash down both of my sides that was itchy and painful, onset maybe a couple of hours after administration of vaccine. With exercise, rash spread and itchy sensation became worse. By the following morning, rash was very red and stretched almost all the way around my abdomen. I took two Benadryl the evening after receiving the vaccine, and the redness died down. Remaining now is dry skin that looks similar to eczema.
34 2021-03-22 pain of skin Headache, fatigue, chills, sweats, body aches, joint pain, skin pain lasting 72 hours
34 2021-03-23 injection site pain L shoulder pain after vaccine, possible subacromial administration
34 2021-03-23 rash macular, rash with redness, skin warm, itchy rash This reaction has occurred twice since my first vaccination. One at 9 days post vaccine and the oth... Read more
This reaction has occurred twice since my first vaccination. One at 9 days post vaccine and the other at 20 days post vaccine. Sudden onset of a hot, swollen, mildly itchy red lacy rash over several areas of the body starting with the face. My face turned bright red and splotchy and was very hot. Then it spread to my neck and chest, then my arms, elbows, and hands, then to my stomach and thighs and butt. I took 2 Benadryl within ten minutes of each reaction starting and the rash slowly disappeared over the next 30 minutes after taking the medicine. No residual rash was left after the reaction. The rash appeared on an empty stomach both times and without any environmental triggers. No other trigger has been identified. No other bodily systems were involved in the reaction other than the skin.
34 2021-03-24 itchy skin Itchy face hours after vaccination took Benadryl, Less then 12 hours after vaccination woke up with ... Read more
Itchy face hours after vaccination took Benadryl, Less then 12 hours after vaccination woke up with ongoing body aches and pain, soreness at vaccinated arm
34 2021-03-24 vaccination site pain hurting from her hand to her chest; stress; nausea and threw up that night; nausea and threw up that... Read more
hurting from her hand to her chest; stress; nausea and threw up that night; nausea and threw up that night; Bell's palsy; arm on the side she got her shot was hurting; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 34 years of age), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma wherein she doesn't take medication, it was usually when she was cold; she had this diagnosis since her childhood. She was diabetic and was diagnosed when she was 16 years old (2002). Concomitant medication included insulin human injection, isophane (HUMULIN N) and insulin human (HUMULIN R), both for diabetes mellitus. Historical vaccine include PFIZER BIONTECH COVID 19 VACCINE first dose on 06Jan2021 for COVID-19 immunisation. She got the second dose and her arm on the side she got her shot was hurting from her hand to her chest for about 10 days. Then she got diagnosed with Bell's Palsy. The left side of her face has been twitching and droopy and not right. She got the second dose on 26Jan2021. Three days later was when she started experiencing the pain on left arm (29Jan2021). The shot was given in the left arm. It took 10 days to heal. Then after that was when she started to feel her face. She tried to call the doctor and they couldn't see her until 08Mar2021 to get diagnosed. She had been on medication for two days. She started one medication on Monday. There had been no improvement yet. One of the medication was Acyclovir 800mg tablet. She was taking it five times per day. She started it on 09Mar2021. The other medication she takes three at the time for the first six days. Then two at a time. It was a steroid. She started it on the 08Mar2021. She added that she was a diabetic and being on the steroid had her blood sugars high now. They said it was stress and not eating right. Investigations included blood work and checked her thyroid, both with unknown result. Then when she got in to the doctor she was diagnosed because it had been going on for five weeks. The arm pain started a couple of days after the vaccination (29Jan2021). It was after 10 days when she developed Bell's Palsy (Feb2021). The day that she got it she had nausea and threw up that night (Feb2021). She had gone to the emergency room for the arm pain as she was in bad pain and didn't go to work for 2 days. The ER told her it could take 10 days. She doesn't remember the exact date. It was sometime the first week of Feb2021. The outcome of vaccination site pain was recovered on 08Feb2021, chest pain was recovered on an unknown date; while unknown for other events. Therapeutic measures were taken as a result of Bell's palsy and vaccination site pain. Information on the lot/ batch number has been requested.
34 2021-03-24 shingles shingles outbreak - mild symptoms felt day after vaccine, followed by full blown outbreak about 5 da... Read more
shingles outbreak - mild symptoms felt day after vaccine, followed by full blown outbreak about 5 days after vaccine
34 2021-03-25 injection site pain 1. Soreness in left arm from neck to fingers, started around shoulder within 5 minutes of injection,... Read more
1. Soreness in left arm from neck to fingers, started around shoulder within 5 minutes of injection, continued to worsen over the day and into next day. 2. Slight sleepiness and minor headache on and off through day 1 and 2. Not sure how long either will last, can report back if needed.
34 2021-03-25 redness, injection site redness Patient complaint of redness on left arm and neck also was flushed in face. No complaint of shortnes... Read more
Patient complaint of redness on left arm and neck also was flushed in face. No complaint of shortness of breath or rash. Vital signs within normal. Pulse Ox %100. Symptoms improved and was discharged home at 1040.
34 2021-03-25 bruising, redness Pfizer COVID-19 Vaccine EUA Patient upon receiving vaccine 2 mins began feel nauseated and hot-... Read more
Pfizer COVID-19 Vaccine EUA Patient upon receiving vaccine 2 mins began feel nauseated and hot- provided ice pack wheelchair and got her to the provider where she was placed on gurney.vitals were taken please see chart. Epi pen was given when patient's lips started to turn red cough and stridor noted please see the notes. Ambulance was call and patient was taken to the hospital see chart. At approximately 0903 peri oral erythema was noted and patient reported chest tightness. Stridor was noted. SpO2 remained stable at 97-98% on RA. EpiPen administered, 911 contacted for transport to ED. 0909 patient reports improved chest tightness, peri-oral erythema improving stridor. EMS transported patient to ED for further evaluation and treatment. ED - does not have chart access. 3/25: ED 3/23/21 Anaphylaxis after receiving Covid vaccine: chest tight, hot, and dizzy. Patient received epi at clinic and epi and benadryl in ambulance. Patient advised not to get 2nd dose. Patient states she picked up epi pens that were prescribed. She reports better. She is tired and has headache, her arm is red and bruised but it looks better. Patient states she will not be getting second dose.
34 2021-03-25 injection site redness, injection site swelling, injection site reaction Red mark and lump under skin at injection site, sore ar,
34 2021-03-25 rash Stomach rash and severe stomach pain 2.5 hours after vaccine
34 2021-03-26 shingles Two months after having received the second dose of covid vaccine I was diagnosed with shingles
34 2021-03-27 injection site pruritus, injection site redness Began with itching at injection site, some redness; anxious. No issues breathing/swallowing. c/o hea... Read more
Began with itching at injection site, some redness; anxious. No issues breathing/swallowing. c/o heart racing, "whoosh" as sat down after vaccine. Recent visit to MD for heartburn/stomach issues and high BP. Patient notes high anxiety of late/re: vaccine. Gave 25 mg po benadryl. BP 148/90; HR 120; p ox 98. Rapid response called; to ED for further monitoring.
34 2021-03-27 injection site pain Extreme lethargy, could not keep eyes open, could not move left eyebrow or top eyelid the next morni... Read more
Extreme lethargy, could not keep eyes open, could not move left eyebrow or top eyelid the next morning, on and off fever and chills, pain at injection site.
34 2021-03-28 injection site swelling, injection site redness, injection site warmth Fever, chills, nausea, joint pain, body aches, swollen lymph node; swollen, red, hot to touch at inj... Read more
Fever, chills, nausea, joint pain, body aches, swollen lymph node; swollen, red, hot to touch at injection site. Began 4 hours after shot and ended 8 am Sunday morning.
34 2021-03-28 injection site tingling Patient reported tingling in injection arm down to fingertips but no numbness or weakness. The patie... Read more
Patient reported tingling in injection arm down to fingertips but no numbness or weakness. The patient denied other symptoms such as shortness of breath or hives. Patient offered to stay past 30 minutes, but she declined and said she would like to go back to work. She agreed to come back to the station if her symptoms were worsening or changing.
34 2021-03-31 rash with redness able to express old blood out of nipple; Chest pains; a minor red rash on one side of breast; This i... Read more
able to express old blood out of nipple; Chest pains; a minor red rash on one side of breast; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of BNT162B2 (Lot Number was EN6198, expiration date was unknown) via an unspecified route of administration at left arm on 21Feb2021 16:45 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took Sumatriptan 1 week before vaccination on Feb2021. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She was not pregnant at the time of vaccination. The patient experienced chest pains in the left upper side close to her collar bone able to express old blood out of nipple and had a minor red rash on one side of breast on 07Mar2021 at 14:00. She did not receive any treatment for the event. Patient had been tested for COVID-19 via nasal swab with negative result on 01Mar2021. The outcome of events was not recovered.
34 2021-04-05 skin discolouration DVT blood clot in leg. Not able to seek care due to high deductible health insurance. Swelling, pain... Read more
DVT blood clot in leg. Not able to seek care due to high deductible health insurance. Swelling, pain, discoloration, bruising in lower leg below soleus muscle and deep pain in calf. Using compression, ice, elevation, massage and aspirin regimen.
34 2021-04-05 rash, skin spots I had an odd petechiae rash appear on my body and then had low blood platelets of 3000. O had to rec... Read more
I had an odd petechiae rash appear on my body and then had low blood platelets of 3000. O had to receive transfusions of IVG Immunoglobin and 100mg of high steriod treatments. To get my platelets up. After 7 days my platelets were up to 143k. Currently still on high doses of steriods and will begin tapering down 10mg less per week starting 4/9/2021
34 2021-04-06 redness sore right breast; chills; body aches; fever of 102.6; more soreness in right breast and a red mark;... Read more
sore right breast; chills; body aches; fever of 102.6; more soreness in right breast and a red mark; diagnosed with mastitis; This is a spontaneous report from a contactable consumer (patient reported for self). A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported), dose 1, via an unspecified route of administration, administered in right arm on 01Mar2021 12:00 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with Covid-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine and did not receive any other medications within 2 weeks of vaccination. The Wednesday after the vaccine, on 03Mar2021 05:30 (also reported as about 36 hours later), patient woke up with a sore right breast. As the day progressed, patient had the chills, body aches, and a fever of 102.6. Patient also noticed more soreness in right breast and a red mark. Patient spoke to OB and was diagnosed with mastitis. The patient was tested for covid post vaccination reported as results of tests and procedures for investigation of the patient on 12Mar2021 as nasal swab: negative. Therapeutic measures were taken as a result of the events reported which included antibiotic. The events were reported as recovered in Mar2021. Information on the lot/batch number has been requested.
34 2021-04-15 rash, hives 24 hours after injection had hives on face, loud rushing sounds in ears, respiratory distress. Took ... Read more
24 hours after injection had hives on face, loud rushing sounds in ears, respiratory distress. Took benedryl and had epi pen ready but never had to administer it. Severe symptoms lasted 3 hours, went to dr next day and began steroids. Unsure if I was exposed to another allergen during the 24 hours but determined it was possible. Had 7 days of severe allergic response side effects of brain fog, loud rushing heart beat noise in head, hives, sensitivity to all allergens , swollen face
34 2021-04-20 injection site rash Soreness from the first night but 3 days later I noticed a large rash up my upper left arm around th... Read more
Soreness from the first night but 3 days later I noticed a large rash up my upper left arm around the injection sight. It is similar to a rash I got from a pneumonia vaccine last fall but I haven?t ever gotten a rash form a flu shot.
34 2021-04-20 hives felt feverish; Slept most of the day and night; few scattered hives; flu like symptoms; Flu like sym... Read more
felt feverish; Slept most of the day and night; few scattered hives; flu like symptoms; Flu like symptoms-woke up freezing; Flu like symptoms-headache; Flu like symptoms- neck pain; Flu like symptoms- body aches; Flu like symptoms- restless; nausea; vomiting; fatigue; diagnosed with vestibular neuritis secondary to the vaccine; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 13:00 (Lot Number: EL3246) as single dose for covid-19 immunisation at age 34 years old. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. No concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 on 18Dec2020 (lot no: EJ1685) for COVID-19 immunization at 34 years old. After receiving the second dose of Pfizer vaccine on 08Jan2021, within 13 hours (09Jan2021 02:00) the patient was ill with flu like symptoms (woke up freezing, headache, neck pain, body aches, restless). Later that morning (09Jan2021), the patient had nausea, vomiting and fatigue. After 36 hours (09Jan2021), profound fatigue, intermittently dizzy, felt feverish but did not confirm; body aches had resolved. On 10Jan2021 01:00, slept most of the day and night, had a few scattered hives in the evening. On day 3 (11Jan2021), since this day the patient has had constant vertigo. She was hospitalized from 15Jan2021 to 16Jan2021, had extensive testing and saw different specialists, and was diagnosed with vestibular neuritis secondary to the vaccine. She never had CoVID before, healthy otherwise, and had negative CoVID antibody testing prior to receiving the vaccine. She was off work for 6 weeks, able to go back for 10 shifts but had worsening of vertigo symptoms and was unable to work x 3 weeks and ongoing; still working with vestibular rehab, still having daily significant vertigo. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. Treatment received included medication and vestibular therapy. The patient underwent covid test (nasal swab) on 16Jan2021 with negative result. The patient recovered from body aches on an unspecified date in Jan2021; while not recovered from the rest of the events.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
34 2021-04-24 rash, hives Measles; hive rash all over my body; hive rash all over my body; This is a spontaneous report from a... Read more
Measles; hive rash all over my body; hive rash all over my body; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in left arm on 04Apr2021 as a single dose for COVID-19 immunisation. Medical history included Lupus and fibromyalgia. There were no concomitant medications. The patient previously took azithromycin and immunoglobulins and experienced allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced measles and had hive rash all over her body on 07Apr2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given in response to the events which included prednisone and allergy medicine. The patient has not been tested for COVID-19 post vaccination. The outcome of the events was not recovered. Information about lot/batch number has been requested.
34 2021-05-05 hives I came down with a bad headache about 2 1/2 hrs after the shot, but then at approximately 11am my ri... Read more
I came down with a bad headache about 2 1/2 hrs after the shot, but then at approximately 11am my right eye developed a red welt on the eyelid and then my eye proceeded to puff up until it was swollen and my eyeball was bright red.
34 2021-05-06 skin discolouration fatigue headache dizziness skin blemishes
34 2021-05-07 shingles Shingles; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female p... Read more
Shingles; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left on 18Jan2021 08:00 (Batch/Lot Number: EL3247; Expiration Date: 18Feb2021) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. Family history included: older brother had shingles in his early to mid 30's and had mild symptoms. Patient previously had flu shot on 2020. The patient developed shingles on 31Jan2021. Patient was asking if it was okay to take the second dose on 08Feb2021 as she was taking valacyclovir 1gm 3 times a day by mouth for 7 days, started on 02Feb2021 for shingles. Event resulted to a physician's office visit. Outcome of the event was not recovered
34 2021-05-12 redness Mild facial erythema flushing; chest tightness; SOB; sore throat; heart rate went up to 127 and bloo... Read more
Mild facial erythema flushing; chest tightness; SOB; sore throat; heart rate went up to 127 and blood pressure up to 170 within a few minutes after getting vaccine; severe allergic reaction within 2 minutes; heart rate went up to 127 and blood pressure up to 170 within a few minutes after getting vaccine; it was difficult to swallow/trouble swallowing; I started to get hot; my heart started racing; inflamed tonsils; fever; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient) reported for a 34-year-old non-pregnant female patient received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration, administration in left arm on 18Mar2021 11:45 (at the age of 34-year-old) (Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. The patient had allergies to Sulfa antibiotics, Lumbar disc herniation, keratosis pilaris, acne. Occasionally the patient drinks alcohol. Concomitant medication included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE) spironolactone, ethinylestradiol, norethisterone acetate (AUROVELA), acetominophen and ibuprofen.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a reaction a severe allergic reaction to the COVID 19 vaccine on 18Mar2021 at 11:45 . It was reported within 2 minutes of receiving vaccine the patient started to get hot, heart started racing, a facial redness, face got bright red and swollen, throat started to swell, and it was difficult to swallow. The patient heart rate went up to 127 and blood pressure up to 170 within a few minutes after getting vaccine. The patient heart rate and blood pressure were high. The patient also experienced inflamed tonsils. On 18Mar2021 at 11:52 the patient experienced also: sore throat, shortness of breath and chest tightness, at 12:00 the patient had mild facial erythema flushing and at an unknown time fever up to 99.5°F. All these with outcome of unknown. The patient was not in anaphylactic shock, but she was initially given diphenhydramine (BENADRYL) to treat the symptoms, but it had no effect. She was admitted to emergency room and was given epinephrine and prednisone and things started to get better. The next day symptoms returned, and patient went to urgent care the next morning. There the patient received another prescription for prednisone for 5 days. After that finished her symptoms returned and was given another round of prednisone for 6 days. The patient was still having slight symptoms that she was treating with fexofenadine (ALLEGRA) twice per day per advice of allergist. The patient was met with an allergist and was slightly concerned and thought it was unusual that this would continue past symptoms of 2 weeks. It was reported that the patient was experiencing slight symptoms, nothing crazy, but was wondering what communication from Pfizer was if someone did have an allergic reaction that most people were treated in emergency room. On an unknown date, the patient had allergy tests and no information found on allergy tests. It was reported that the patient antibody testing was not currently recommended to assess for immunity. The patient was discharged with instructions to get an epi pen in case anything got crazy, and her husband drove her home. It was stated as soon as it was her turn the system disconnected. The patient stated the only reason she waited after 4 hours was because she was 5th in line, and it took 2 hours 50 minutes to get to be her turn. The patient was on hold for four hours and she got hung up on, but she was not sure if the system was down, but she got an email and, in the case, it had her interactions. Among the Vaccine recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most reported local reaction, with less than 1% of participants. In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. A cross all age groups reporting severe pain. Since the vaccination the patient was not tested for COVID-19. The outcome of the events was recovering. The patient was suggested not to get the second dose of COVID-19 vaccination of any type. No follow-up attempts are needed. No further information is expected. Follow-up (27Apr2021): This is a follow-up spontaneous report from a contactable Pharmacist. New information included: patient medical history, concomitant medications, new non serious adverse event (sore throat, shortness of breath and chest tightness, mild facial erythema flushing and fever up to 99.5°F.); Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be excluded based on the temporal relationship The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
35 2020-12-31 injection site pain Dizziness, chills, fever, muscle aches, pain at the injection site
35 2020-12-31 bruising Within the first 15 minutes of receiving the vaccine I was was extremely tired. As time went on, th... Read more
Within the first 15 minutes of receiving the vaccine I was was extremely tired. As time went on, this seemed to subside. Tiredness has appeared to come and go over the last few days. Every morning I have woken up with tingling in my left hand, as though there are pins and needles in my left hand. My left arm feels weaker and feels some numbness when more pressure is placed on it. I have a bruise that appeared above my left wrist. I have reached out, as this is my employer and I have not heard back. Assuming they were closed due to New Year?s Day.
35 2021-01-01 itchy skin, sensitive skin, rash macular Facial itiching with hypersensitive skin started a 2-3 days after injection. Swelling of face and ey... Read more
Facial itiching with hypersensitive skin started a 2-3 days after injection. Swelling of face and eyes and blotchy facial skin 13 days after injection. Seen by ED physician for steroids and benadryl. Slight decrease in swelling 24-36 hrs post start of steroid regimen.
35 2021-01-02 hives Hives began one week after vaccine. Went to urgent care on two different occasions, initially told ... Read more
Hives began one week after vaccine. Went to urgent care on two different occasions, initially told to continue Otc antihistamines, given prescription at second visit.
35 2021-01-03 redness, skin warm, itchy skin Moderate local reaction. Swelling, redness, pain, hot to touch, itchy for 5+ days.
35 2021-01-03 injection site pain Severe fatigue 2 hours after the shot lasting for 36 hours. Pain throughout the upper arm that recei... Read more
Severe fatigue 2 hours after the shot lasting for 36 hours. Pain throughout the upper arm that received the injection lasting for 36 hours treated with Advil.
35 2021-01-03 rash Shortly after receiving the vaccine I broke out in a rash on my chest and torso. Over the next few w... Read more
Shortly after receiving the vaccine I broke out in a rash on my chest and torso. Over the next few weeks it has seemed to get worse covering more surface area. I contacted my Doctor to see what to do and if I should get the second dose.
35 2021-01-03 rash maculo-papular, rash macolopapular rash on the legs, no treatment given besides antihistamines
35 2021-01-04 vaccination site pain 2 vesicles appeared on roof of mouth; Red bumps (rash) appeared in mouth; Left arm also very stiff/s... Read more
2 vesicles appeared on roof of mouth; Red bumps (rash) appeared in mouth; Left arm also very stiff/sore; Left arm also very stiff/sore; This is a spontaneous report from a contactable other healthcare professional (HCP). This 35-year-old female HCP reported for herself that she received BNT162B2 (lot number EH9899) 1st dose Intramuscular at left arm on 27Dec2020 at 12:00 PM for Covid-19 immunization. Medical history was not provided. Concomitant therapy included birth control. The patient experienced red bumps (rash) appeared in mouth, and 2 vesicles appeared on roof of mouth within 24-32 hours after receiving vaccine. Left arm also very stiff/sore for 24 hours after receiving vaccine. Event onset time was reported as 12:00 PM on 28Dec2020. No treatment was received for the events. The outcome of the event was resolving.
35 2021-01-04 itchy skin Feeling of warmth, flushing, pruritic, eyelid swelling
35 2021-01-04 vaccination site pain Feverish; Severe arm pain; Severe arm pain and decreased mobility; Headache; Fatigue; Sore throat; B... Read more
Feverish; Severe arm pain; Severe arm pain and decreased mobility; Headache; Fatigue; Sore throat; Body aches; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received first dose (BNT162B2, Lot number Eh9899), via an unspecified route of administration on 28Dec2020 17:30 at 35 years old at Arm Left at single dose for COVID-19 immunization. The medical history included Allergies to Penicillin. The concomitant medications were none. On 28Dec2020 21:30 the patient experienced Severe arm pain, decreased mobility, Headache, Fatigue, Sore throat, Body aches, Feverish. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The information on the batch number has been requested.
35 2021-01-04 injection site pain, injection site redness, injection site swelling Patient reported burning at the injection site shortly after receiving vaccine. She had a burning /... Read more
Patient reported burning at the injection site shortly after receiving vaccine. She had a burning / swelling sensation of her tongue and otherwise felt unwell. She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy. She reports that her HR is usually 130 or less. She had a BP that ranged between 149-160/96-105. She reports this is elevated for her. Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
35 2021-01-04 injection site pain, injection site swelling, injection site redness Redness around injection site - larger than a half dollar sized and swelling/tenderness
35 2021-01-04 vaccination site pain, vaccination site swelling, vaccination site redness, vaccination site warmth Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling a... Read more
Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; This is a spontaneous report from a contactable Nurse reporting for herself. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 22Dec2020 08:00 as a single dose in the left arm (Dose number: 1) for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There were no other vaccines received by the patient within 4 weeks prior to the COVID-19 vaccine. Medical history included diagnosed with COVID-19 on an unknown date prior to vaccination. There were no allergies to medications, food, or other products. Concomitant medication included atorvastatin (ATORVASTATIN), ethinylestradiol, norgestimate (TRI LO MILI), and vitamin D2 (VITAMIN D2). On 24Dec2020 at 16:00, the patient experienced swelling and redness an inch belowinjection site, tenderness, site was warm to touch, and commented "it's 4 days already after vaccination date" (as of reporting on 26Dec2020). There was no treatment received for the events. The clinical outcome of the events swelling and redness an inch below injection site, tenderness, and site was warm to touch was not recovered. The patient was not COVID tested post vaccination.
35 2021-01-04 itchy rash rash that began in my right arm and fingers and over the next week spread to my entire body includin... Read more
rash that began in my right arm and fingers and over the next week spread to my entire body including my face/ rash is very itchy; The rash is very itchy and swollen; This is a spontaneous report from a contactable nurse, who is also the patient. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: Fl0140), via an unspecified route of administration in the right arm on 17Dec2020 at 15:45 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient had no relevant medical history. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included bupropion hydrochloride (WELLBUTRIN XL) 175mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 20:00 the patient broke out in a rash that began in the right arm and fingers and over the next week spread to the patient's entire body including the face. Per the patient the rash was very itchy and swollen. The patient visited an emergency room due to the events. The patient was treated for the events with oral OTC Benadryl and hydrocortisone cream, which the patient stated were not helping. The clinical outcome of the events itchy rash and swelling was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
35 2021-01-05 rash macular, rash, itchy rash Developed red splotchy rash on right ankle. Rash has spread to thighs, backs of legs, shoulder blade... Read more
Developed red splotchy rash on right ankle. Rash has spread to thighs, backs of legs, shoulder blades, arm pits and tops of the arms. Rash also itches.
35 2021-01-05 hives Hives, burning sensation in her arms, anxiety. Noted she felt like she was hyperventilating.
35 2021-01-05 injection site pain Injection site arm soreness, bad headache, fatigue that began about 6 hours after the vaccine and th... Read more
Injection site arm soreness, bad headache, fatigue that began about 6 hours after the vaccine and then lasted for 24 hours, but improved over time
35 2021-01-05 itchy skin Noted had history of various allergies. Received vaccine at 6:06 pm and about 10 minutes later note... Read more
Noted had history of various allergies. Received vaccine at 6:06 pm and about 10 minutes later noted headache. BP 150/70; p 86. Then neck pain, bilateral leg soreness, and hip pain; R foot tingling, felt warm, itching, no rash noted. Treated with 25mg benadryl at 0624 pm; BP 130/82. And went to ED for evaluation via wheelchair/personnel.
35 2021-01-05 rash Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), art... Read more
Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; This is a spontaneous report from a Non-contactable Physician (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 23Dec2020 at first single dose at arm left for covid-19 immunisation. The patient received the vaccine at hospital. Medical history included migraine, dermatitis atopic. The patient's concomitant medications were not reported. The patient experienced Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache on 24Dec2020. No treatment for events. The outcome of events was recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
35 2021-01-05 vaccination site itchiness, vaccination site rash, vaccination site redness Red itchy rash at injection site; Red itchy rash at injection site; Red itchy rash at injection site... Read more
Red itchy rash at injection site; Red itchy rash at injection site; Red itchy rash at injection site; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), intramuscular (left arm) on 22Dec2020 15:15 at single dose for Covid-19 immunization. The patient's medical history included Intracranial HTN (intracranial hypertension) and known allergies: PCN (Penicillin). Concomitant medication included acetazolamide sodium (DIAMOX), topiramate (TOPAMAX), and Multivitamin. The patient previously took Augmentin, tetracycline, and Ceclor and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced red itchy rash at injection site on 26Dec2020. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
35 2021-01-05 hives chronic auto immune response; angioedema/tongue is swollen; urticaria/hives; This is a spontaneous r... Read more
chronic auto immune response; angioedema/tongue is swollen; urticaria/hives; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the right arm on 28Dec2020 10:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), omeprazole (PROTONIX), naproxen sodium (ALEVE), and birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 16:00, the patient have a chronic auto immune response in the form of urticaria and angioedema. The symptoms of hives as well as swollen tongue was maintained with antihistamines. Outcome of the events was not recovered. The events were considered non-serious. The following information on the batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events chronic autoimmune response in the form of urticaria and angioedema with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-01-05 vaccination site pain fatigue; Yellow urine; injection site pain; This is a spontaneous report from a contactable pharmaci... Read more
fatigue; Yellow urine; injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old female patient received the first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL0142), intramuscular on the left arm on 31Dec2020 at 19:30 at a single dose for immunization. Medical history was not reported. There were no concomitant medications. The patient had no other vaccine in four weeks, no Covid prior vaccination and has not been tested positive for Covid post vaccination. The patient had yellow urine, injection site pain, and fatigue on 01Jan2021, and received Tylenol or ibuprofen as treatment for the events. The events had not resolved.
35 2021-01-06 rash with redness, rash Vaccination at 0639 0650 erythematous rash across neck & upper chest - observation extended to 30 m... Read more
Vaccination at 0639 0650 erythematous rash across neck & upper chest - observation extended to 30 min denied: SOB, lightheadedness throat tightness or scratchiness 0655 25mg Benadryl liquid given VS BP 130/90 HR 100, O2 Sat 100% 0705 VS BP 130/92 HR 88 O2 Sat 100% 710 returned to work feeling well
35 2021-01-06 itchy skin Was taken to ED on 12/21 from vaccine clinic with throat tightness, generalized itching, facial swe... Read more
Was taken to ED on 12/21 from vaccine clinic with throat tightness, generalized itching, facial swelling. Received Epi injection x 1. benadryl, pepcid and Dexamethasone, was stable and sent home. On 12/22 back to ED for recurrent itching, tightness in throat, and face fullness. Pt was stable, advised to continue Pepcid and Benadryl, and given rx for Medrol dose pack to have available prn if symptoms worsened.
35 2021-01-06 injection site reaction severe back pain, headache, injection site reaction, fatigue, chills
35 2021-01-07 injection site pain, injection site inflammation COVID-19 vaccination administered IM in left deltoid around 6am. Patient called pharmacy around 10am... Read more
COVID-19 vaccination administered IM in left deltoid around 6am. Patient called pharmacy around 10am and complained that the injection was delivered too high and she was experiencing pain at the site. Vaccine placed high on L shoulder, just below acromion process, at or above humeral head. Seemingly placed between acromion process and humeral head, near or in soft tissue/bursa. Site pain is inflammatory in nature and does not seem to affect muscles, but instead is contained within joint itself.
35 2021-01-07 injection site pain Chills, muscle pain, headache, pain at injection site
35 2021-01-07 injection site pain Fever (101F), chills, nausea, myalgias, injection site soreness extending to shoulder and down to el... Read more
Fever (101F), chills, nausea, myalgias, injection site soreness extending to shoulder and down to elbow, fatigue
35 2021-01-07 vaccination site pain Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly... Read more
Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
35 2021-01-07 injection site pain Left hand weakness and tingling, dizziness, injection site throbbing 10 min post vax Observation, fl... Read more
Left hand weakness and tingling, dizziness, injection site throbbing 10 min post vax Observation, fluids, food Sxs largely resolved after 30 mins of close monitoring, returned to shift feeling a little lightheaded NKA
35 2021-01-07 injection site redness, hives, injection site hives Noticed a tingling sensation in her left arm radiating down to her fingertips on 12/31/2020. Redness... Read more
Noticed a tingling sensation in her left arm radiating down to her fingertips on 12/31/2020. Redness at the injection site and hives on the left arm where injection was given. Patient went to ER on 01/01/2021 due to numbness and tingling. Received Benadryl at the ER.
35 2021-01-07 itchy skin Patient complained of itching on back of neck and behind ears. Denied shortness of breath, difficult... Read more
Patient complained of itching on back of neck and behind ears. Denied shortness of breath, difficulty breathing, rash or sweating. 25 MG IM Benadryl administered at 1019. Patient watched for 15 minutes following Benadryl administration. Patient denied any symptoms following.
35 2021-01-07 skin spots Petechiae running down left arm into hand and left chest. Noticed at approximately 10am 1/7/2021 pro... Read more
Petechiae running down left arm into hand and left chest. Noticed at approximately 10am 1/7/2021 progressively got worse at about 12:00pm contacted vaccine clinic. They told me I should go to the Emergency Room. Went to Emergency Room and had multiple blood tests performed, all came back okay. They told me to come back if it gets worse. 1/8/2021 petechiae seem to be resolving. Just interesting that it was just on the left side of my body where I received the vaccine.
35 2021-01-07 hives Pt states she started feeling flushed, started getting hives around neck, and tightness of the right... Read more
Pt states she started feeling flushed, started getting hives around neck, and tightness of the right leg
35 2021-01-07 bruising acute mild edema to affected forearm with light bruising of unknown origin without known injury; acu... Read more
acute mild edema to affected forearm with light bruising of unknown origin without known injury; acute mild edema to affected forearm with light bruising of unknown origin without known injury; unknown origin without known injury, tenderness to touch; Tennis elbow of opposite vaccine extremity around same time as vaccine, just after; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the right arm on 10Dec2020 in a hospital at a single dose for COVID vaccination. Medical history included anxiety and chronic migraines with aura. The patient has no known allergies. The patient was not pregnant at the time of vaccination, did not receive any other vaccine in four weeks, was not diagnosed with COVID prior to the vaccination, and was not tested for COVID post-vaccination. Concomitant medications included desvenlafaxine succinate (PRISTIQ), bupropion hydrochloride (WELLBUTRIN), and cyclobenzaprine. In Dec2020, the patient had tennis elbow of opposite vaccine extremity around the same time as the vaccine, just after. On 01Jan2021 at 04:00 AM, the patient experienced acute mild edema to affected forearm with light bruising of unknown origin without known injury, tenderness to touch. The patient did not receive any treatment for the events. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect). Information on the lot/batch number has been requested.
35 2021-01-07 vaccination site pain fever 101; myalgias; arthralgias; headache; injection site pain; This is a spontaneous report from a... Read more
fever 101; myalgias; arthralgias; headache; injection site pain; This is a spontaneous report from a contactable physician. A 35-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular in the left arm on 22Dec2020 16:00 at single dose for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergy to Sulfa and amoxicillin; clavulanic acid (AUGMENTIN). The patient had concomitant medications. On 23Dec2020 04:0 the patient experienced fever 101, myalgias, arthralgias, headache and injection site pain with outcome of recovered. The patient received paracetamol (TYLENOL) and Ibuprofen as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
35 2021-01-08 injection site pain Lower gums and lower lip bleeding gums about hour 1/2 after the inj. It lasted about 3-4mins. Pain... Read more
Lower gums and lower lip bleeding gums about hour 1/2 after the inj. It lasted about 3-4mins. Pain at the inj site.
35 2021-01-08 rash Severe rash around neck area. Warmth in the area of the rash
35 2021-01-08 injection site pain fatigue the evening of injection lasting 4-5 days, fever Tmax 99.9 starting 72hrs post vaccine last... Read more
fatigue the evening of injection lasting 4-5 days, fever Tmax 99.9 starting 72hrs post vaccine lasting 24hr, myalgias x 48hrs starting with the fever, mild injection site soreness, managed with ibuprofen
35 2021-01-09 rash, itchy skin *I have had a very hard time staying warm since the shot the *all of Friday I was nausiouse and tie... Read more
*I have had a very hard time staying warm since the shot the *all of Friday I was nausiouse and tiered (the day after the shot) * when I woke the next morning my face chin area itched over the past 2 days my face has broken out it itches and is spreading I have tried dubbling my allergy pill taking Benadryl washing my face with Dawn dish soap its 1130am Sunday the 10th jan the rash is all the way up below my upper cheek bones
35 2021-01-09 injection site swelling, injection site redness, injection site pain Injection site swelling, redness and pain, started immediately post injection, fatigued that evening... Read more
Injection site swelling, redness and pain, started immediately post injection, fatigued that evening. Day following vaccine under arm(lymph node area) of injection arm swelling and pain.
35 2021-01-09 injection site swelling, rash with redness, injection site pain, injection site numbness, injection site redness, injection site pruritus Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild ... Read more
Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild feeling of swelling of tongue and lips, coughing, tightness in chest, flushed cheeks, Red rash under left arm pit, temp of 100.4. Body aches.
35 2021-01-10 pain of skin I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the ... Read more
I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the typical side effects that I had read about. Chills, Severe Headache, All over body, joint, and skin pain. Then developed Fever around 102. Saturday headache was mild, very fatigued, skin felt sunburnt/pain, no fever, was still achy. Temp highest was 99.4 that evening. Noticed palpable clavicular lymph nodes that were very tender. Then noted an axillary one that was about marble sized and tender as well. Sunday about the same- was able to get up and do housework but felt fatigued easily. No temp. Sunday evening developed tenderness in neck area and possible lymph node swelling and decreased ROM. Also at times if I change positions I have a very brief moderate headache. I did wake up in the middle of the night drench with sweat which is very abnormal for me. Neck is the biggest complaint as of now. I called my PCP and they said to call employee health.
35 2021-01-10 skin burning sensation, pain of skin I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the ... Read more
I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the typical side effects that I had read about. Chills, Severe Headache, All over body, joint, and skin pain. Then developed Fever around 102. Saturday headache was mild, very fatigued, skin felt sunburnt/pain, no fever, was still achy. Temp highest was 99.4 that evening. Noticed palpable clavicular lymph nodes that were very tender. Then noted an axillary one that was about marble sized and tender as well. Sunday about the same- was able to get up and do housework but felt fatigued easily. No temp. Sunday evening developed tenderness in neck area and possible lymph node swelling and decreased ROM. Axillary lymph node is larger than a marble currently. Also at times if I change positions I have a very brief moderate headache. I did wake up in the middle of the night drench with sweat which is very abnormal for me. Neck is the biggest complaint as of now. I called my PCP with the above complaints who referred me to employee health.
35 2021-01-10 injection site pain Pain and tenderness at injection site following 12 hours post-vaccination. Head fogginess, difficult... Read more
Pain and tenderness at injection site following 12 hours post-vaccination. Head fogginess, difficulty focusing on tasks, and light-headedness began around 9:00AM on 1/8/2021, and progressively worsened throughout course of day. Severe body aches and joint pain (entire body) with severe malaise and fatigue began later that evening about 8:00PM on 1/8/2021 until about 12:00PM on 1/9/2021. Took Tylenol 500mg as indicated for 24 hours. Symptoms resolved by mid-afternoon 1/9/2021.
35 2021-01-10 rash, injection site rash RASH DEVELOPED AT INJECTION SITE 12/23/2020 AND SPREAD TO REST OF BODY. RASE DESCRIBED AS SMELL RAIS... Read more
RASH DEVELOPED AT INJECTION SITE 12/23/2020 AND SPREAD TO REST OF BODY. RASE DESCRIBED AS SMELL RAISSE BUMPS EMPLOYEE USE BENADRLY AND HYDROCORTISONE CREAM TO TREAT.
35 2021-01-10 injection site swelling, injection site pruritus, injection site pain, injection site redness Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; H... Read more
Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; Headache; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Tachycardia / heart rate was 144-152; painful to breath and she was grunting; also said that the injection site itched a little bit.; Fever; First dose on 17Dec2020, second does on 04Jan2021; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) ( (lot number was unknown) intramuscularly on 17Dec2020 at 0.3ml, and the second single dose (lot number EJ1685) intramuscularly on 04Jan2021 07:45 at 0.3ml, for COVID-19 prophylaxis. Medical history included ongoing diabetes. Her diabetes was diagnosed about 6 months ago (reported on 06Jan2021) and was well controlled. Her glucose was at 140 at the ER (emergency room) even after drinking a drink that had sugar in it. The patient's concomitant medications were not reported. The patient received the second dose on 04Jan2021 at 07:45 and experienced a severe reaction hours after she received it, and she ended up having to go the ER and that they were baffled about what happened. She reported her symptoms were: fatigue, joint pain mainly in her knees, bone pain that did not feel like muscle pain, headache, swollen lymph nodes in the left axilla, and swelling, redness, pain, and soreness in the left arm at the injection site and also said that the injection site itched a little bit. Her symptoms started about 9-10 at night on 04Jan2021. She said that she felt like with the second dose she noticed the soreness and pain and redness at injection site after about 2 hours after receiving the second dose, which was sooner than with the first injection. The fever started with the chills and body aches. The chills and body aches started at 22:00 on 04Jan2021. She took acetaminophen and melatonin to try and sleep it off. Fever was after that at around midnight 04Jan2021 and she was burning in fever and her temperature was 104. She stated she started taking layers off and got out from under her covers. She had a sweater on when she took her temperature and her axillary temperature was 105. She said that she got into a hot shower because that was the only thing that provided comfort to her chills. She had not had any chills in about the last 12 hours though (as reported on 06Jan2021). She said that the body aches were so severe that she just sat in her bed and cried. She had tachycardia and she was grunting in pain. She was rotating ibuprofen and acetaminophen and then her fever was not as high. She stated that if her fever came back it was lower each time, and if she did not take the medications though, the bone pain was excruciating. She said that with the bone pain it was like no-one can hold her hand or hug her. Fatigue started at around midnight 04Jan2021. Her headache was at midnight. She felt like she had a headband on and was radiating down the back of her neck. She noticed the lymph nodes were swollen after she went to the ER at around 07:00-08:00 05Jan2021. She was walking with pillow under her arm, and if she moved or lifted her arm it hurt. She went to the ER at 01:00 05Jan2021. Her blood pressure was 90/50, her heart rate was 144-152 at rest, temperature was 102.8, O2 saturation was 95-96. She said that it was painful to breath and she was grunting, but did not have any breathing issues. The nurse thought she was septic and notified the doctor. The nurse and the doctor did not think it was the vaccine and thought that she was COVID-19 positive. But after they tested her, she was negative for flu and COVID and they were baffled. They were unclear on what happened and did not think it was from the vaccine. They bolused her 1 liter of Normal Saline and gave her a dose of Fentanyl that minimally helped with the bone pain. She was also given 30mg of ketorolac (TORADOL) IV (intravenous) and that significantly improved her pain. She was there a total of 3 hours. She was admitted to the back area of the ER. She said that they drew labs and everything was within normal limits. Her CRP (C-reactive protein) was 30 and her lactate was at 1.5. She said that they told her that she was most likely having an immune response to the vaccine. Her heart rate and blood pressure came to a more normal range and everything returned to baseline. Her heart rate was 109. She was told to rotate paracetamol (TYLENOL) and ibuprofen for at least the next 24 hours and hydrate. The events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were serious due to hospitalization from 05Jan2021 to 05Jan2021. The patient was recovering from fever, chills, joint pain, headache, heart rate and blood pressure, not recovered from fatigue, bone pain, swollen lymph nodes and swelling, pain, redness and soreness at the injection site. The event swollen lymph nodes worsened. The outcome of "injection site itched a little bit" was unknown. The reporter considered the events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were all related to the vaccine; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, chills, fatigue, pain, arthralgia, bone pain, headache, lymphadenopathy, vaccination site erythema, vaccination site swelling, vaccination site pain, blood pressure decreased, tachycardia, grunting and vaccination site pruritus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-01-10 injection site pain tiredness, headache, muscle pain, chills, joint pain, fever, injection site pain, general feeling un... Read more
tiredness, headache, muscle pain, chills, joint pain, fever, injection site pain, general feeling unwell
35 2021-01-11 injection site pain, injection site redness, injection site warmth 1/9/21 no pain and no red mark 1/10/21 ? perfect red circle where vaccine was given with pain, hot ?... Read more
1/9/21 no pain and no red mark 1/10/21 ? perfect red circle where vaccine was given with pain, hot ? unable to wear sleeve over spot, difficult to sleep, and could feel it even when breathing 1/11/21 ? marked vaccine area with pen line ? see picture below. Shoulder tender with movement above 90degrees 1/12/21 ? redness is spreading outside of pen more medially, slightly laterally ? shoulder tenderness is still the same level
35 2021-01-11 itchy skin, rash 30 minutes after administration, my tongue and mouth became tingly and "fuzzy" causing me to have to... Read more
30 minutes after administration, my tongue and mouth became tingly and "fuzzy" causing me to have to continually clear my throat. My neck then began to itch and I broke out into a rash around the front of my neck.
35 2021-01-11 hives, injection site pain, injection site hardening Approximately 12 hours after vaccine present with vertigo, that lasts for approximately 24-28 hrs. 5... Read more
Approximately 12 hours after vaccine present with vertigo, that lasts for approximately 24-28 hrs. 5 days after vaccine started presenting with hives, self resolving, migratory. Some other common side effects already known were also present like chills, sore throat, headache, nauseas, tiredness, pain and induration at injection site.
35 2021-01-11 injection site redness, injection site pruritus Fever of 101, chills, muscle aches, headache about 13 hours after injection. All of those side effec... Read more
Fever of 101, chills, muscle aches, headache about 13 hours after injection. All of those side effects are gone but I still have a red, itchy hot spot on arm where injection given.
35 2021-01-11 injection site pain Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of to... Read more
Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure. The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Bell's palsy and other reported events due to temporal relationship. However, the Bell's palsy may possibly represent a concurrent medical condition. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-11 injection site swelling, injection site redness, injection site hardening Local site reaction: erythema, swelling, induration at site of injection.
35 2021-01-11 skin burning sensation, blister Migraine day of vaccine Fever of 101.4 to 102.7 day 2 after vaccine Skin feeling like it?s burning/b... Read more
Migraine day of vaccine Fever of 101.4 to 102.7 day 2 after vaccine Skin feeling like it?s burning/blistering day 2after vaccine Severe body aches and cramps day 2 after vaccine
35 2021-01-11 hives, rash Severe sore arm for 2 days after vaccine. Rash/hives for 3 days after vaccine
35 2021-01-11 hives broke out in hives, sweaty, pale, complained of dizziness and nausea
35 2021-01-11 itchy rash, hives, rash papular hives; raised papular rash bilateral lower extremity; Pruritic rash; This is a spontaneous report fr... Read more
hives; raised papular rash bilateral lower extremity; Pruritic rash; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Jan2021 14:00, the patient experienced pruritic rash then on 06Jan2021 10:00, the patient experienced hives and raised papular rash bilateral lower extremity. No angioedema. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included nasal swab was negative on 30Dec2020. It was reported that the patient has been tested for COVID-19 on an unspecified date since the vaccination. Outcome of the events was recovering. The events were considered non-serious. Information on the lot/batch number has been requested.
35 2021-01-11 rash nausea, tingling light headed ness. 24 after injection- Rash started on lower extremities. no itchi... Read more
nausea, tingling light headed ness. 24 after injection- Rash started on lower extremities. no itching. migraine. nausea, dizziness. positive D Dimer. Shortness of breath Treatment: IV fluids, Reglan. IV Tylenol. Covid test- negative. Na 121.
35 2021-01-11 vaccination site pain severe myalgia 10/10 entire body affected; Hyperesthesia; violent chills/rigors; injection site pain... Read more
severe myalgia 10/10 entire body affected; Hyperesthesia; violent chills/rigors; injection site pain (worse than prior dose); This is a spontaneous report from a contactable physician (patient herself). A 35-year-old female patient received second dose of PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left arm) on 05Jan2021 at 11:45 a.m., at a single dose, for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD) and allergic rhinitis. Concomitant medications included loratadine (CLARITIN), methylphenidate hydrochloride (CONCERTA), fluticasone propionate (FLONASE), and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 17Dec2020 for COVID-19 immunization and experienced injection site pain; and isoniazid and experienced rash. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 06Jan2021, at 12:00 a.m., the patient experienced severe myalgia 10/10 entire body affected, hyperesthesia, violent chills/rigors, and injection site pain (worse than prior dose), peaked approximately 12 hours after dose. Patient has no fever. It was reported that first dose side effect of moderate 6/10 injection site pain in Dec2020, responded well to naproxen. The patient did not receive treatment for the events. Patient did not seek medical care, because she and her husband are both intensive care unit (ICU) physicians. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.
35 2021-01-12 sensitive skin Body aches, fatigue, headache, sore throat, very sensitive skin-felt like a sunburn All but fatigue... Read more
Body aches, fatigue, headache, sore throat, very sensitive skin-felt like a sunburn All but fatigue resolved after 22 hours
35 2021-01-12 rash Dose # 1- Disseminated Nonpruritic rash Dose # 2 - chills, myalgia Both- Amenorrhea with negative ... Read more
Dose # 1- Disseminated Nonpruritic rash Dose # 2 - chills, myalgia Both- Amenorrhea with negative preg tests. This is atypical for me.
35 2021-01-12 injection site pain Fever of 100.4 Fatigue Very sore arm where injection was given
35 2021-01-12 injection site pain, injection site swelling Fever, vomitting, nausea. Unable to hold down water, body aches, no appetite, overall feeling awful,... Read more
Fever, vomitting, nausea. Unable to hold down water, body aches, no appetite, overall feeling awful, pain and swelling at injection site
35 2021-01-12 injection site pain H/A, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, heart bothering her... Read more
H/A, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, heart bothering her, feels warm, tired, heat surge, loss of appetite, SOB, Had COVID May 2020.
35 2021-01-12 hives Patient got fevers to 101, chills, the night of the immunization, that lasted 2 days. 2 days after ... Read more
Patient got fevers to 101, chills, the night of the immunization, that lasted 2 days. 2 days after the shot, she got hives. She also got bodyaches, which lasted 4 days, headaches, which persistent at day 13, fatigue, which persists at day 13, and head congestion, which persists at day 13. She feels like she had COVID all over again, although she is improving. She is very hesistant to take the second immunization, for fear of what it might do to her. Of note, she had moderately severe COVID starting on July 10, 2020. She was almost hospitalized. She had long hauler's syndrome, and it took her 11 weeks to feel well enough to be able to work full time again.
35 2021-01-12 hives She developed fevers to 101 that night, and chills, which lasted 2 days. 2 days after immunization,... Read more
She developed fevers to 101 that night, and chills, which lasted 2 days. 2 days after immunization, she got hives, which resolved. She got body aches, which lasted 4 days, and headaches, fatigue, and head congestion, which are improving, but persist at day 13. Of note, she had COVID on 7/10/2020 and was a long hauler. She was nearly hospitalized. It took her 11 weeks to fully recover.
35 2021-01-12 injection site redness, injection site pruritus, rash Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other th... Read more
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild, Systemic: Nausea-Mild, Systemic: RESPIRATORY DISTRESS-Mild; symptoms lasted for 1 day
35 2021-01-12 injection site pain h/a, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, feels warm, tired, ... Read more
h/a, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, feels warm, tired, warm surges.
35 2021-01-13 injection site pain 12 hrs after first and second vaccines: injection site pain, fever 100F, sweating, body aches, joint... Read more
12 hrs after first and second vaccines: injection site pain, fever 100F, sweating, body aches, joint pain, headache, malaise. First vaccine side effects lasted 1-2 days. Just had second vaccine yesterday, symptoms have not resolved yet
35 2021-01-13 rash Approximately 10 days after I received the Covid vaccine shot I started noticing a few bumps in my b... Read more
Approximately 10 days after I received the Covid vaccine shot I started noticing a few bumps in my backs that look like pimples. A few days later I noticed it spreads all over my back and that was when I decided to see a doctor and reported just incase was a allergic reaction to the vaccine.
35 2021-01-13 vaccination site pain First dose side effect of moderate 6/10 injection site pain; This is a spontaneous report from a con... Read more
First dose side effect of moderate 6/10 injection site pain; This is a spontaneous report from a contactable physician. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 17Dec2020 11:00 at single dose for an COVID-19 immunization. The patient medical history included attention deficit hyperactivity disorder (ADHD), allergic rhinitis (no serious/life threatening allergies). Known allergies: isoniazid (rash). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. First dose side effect of moderate 6/10 injection site pain, responded well to naproxen. Did not seek medical care. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovering. Information on the Lot/Batch Number has been requested.
35 2021-01-13 injection site pain Injection site pain, body aches, joint pain, Improving.
35 2021-01-13 vaccination site pain Left deltoid area is tender to touch, weak when lifting, painful with lifting objects and movement o... Read more
Left deltoid area is tender to touch, weak when lifting, painful with lifting objects and movement of arm that involves lifting of the arm.; Left deltoid area is tender to touch, weak when lifting, painful with lifting objects and movement of arm that involves lifting of the arm.; Left deltoid area is tender to touch, weak when lifting, painful with lifting objects and movement of arm that involves lifting of the arm.; This is a spontaneous report from a contactable nurse (patient) reported that a 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history was reported as none. The patient was not pregnant. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), valacyclovir, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); all were taken from unspecified dates for unspecified indications. On 01Jan2021, it was reported that the patient's left deltoid area is tender to touch, weak when lifting, painful with lifting objects and movement of arm that involves lifting of the arm. The outcome of the events was not recovered. No therapeutic measures were taken as result of the reported events. No follow-up attempts are possible; information about lot number was already obtained.
35 2021-01-13 injection site swelling, injection site numbness, injection site tingling Numbness, tingling in R arm distal to injection site. Swelling at injection site. Restricted movemen... Read more
Numbness, tingling in R arm distal to injection site. Swelling at injection site. Restricted movement due to pain.
35 2021-01-13 hives Patient experiences L posterior elbow urticaria and L arm and lower extremities swelling. No facial ... Read more
Patient experiences L posterior elbow urticaria and L arm and lower extremities swelling. No facial swelling. No drooling. Able to speak in full sentences.
35 2021-01-13 itchy skin, rash Previous report filed 12/23. On 12/25 I woke up with rash on face, neck, arms, and chest. Itchy. Too... Read more
Previous report filed 12/23. On 12/25 I woke up with rash on face, neck, arms, and chest. Itchy. Took Benadryl. Went away. On 12/27 I have another bout of palpitations that lasted 30 mins with heart rate at 130s at rest with dizziness and lightheaded ness.
35 2021-01-13 itchy skin, redness Voiced s/s of itching @ 1232pm. Voices s/s to L side of face. Slight redness noted bilateral cheek... Read more
Voiced s/s of itching @ 1232pm. Voices s/s to L side of face. Slight redness noted bilateral cheeks and L ear. Continued to c/o s/s @ 1238 no relief. Benadryl 25mg given @ 1238. Redness still remains to area, heat also noted to L ear. Remains in observation @ 1238. Remains to have slight redness to areas. Denies any other s/s of distress. Left observation @ 1308. Voices allergies of Peanuts,Tree Nuts, Latex, Melons, and Bananas. Does have chronic illness's of Asthma, and Seasonal Allergies.
35 2021-01-13 injection site rash rash (itchy bumps) at injection site only
35 2021-01-14 injection site swelling, injection site redness, injection site warmth 1/12/21 - developed significant redness, warmth, swelling L upper arm and area near collarbone.
35 2021-01-14 injection site pain 1/6/21 I had fatigue, fever up to 101F, chills, headache, injection site pain, and joint pain that a... Read more
1/6/21 I had fatigue, fever up to 101F, chills, headache, injection site pain, and joint pain that all resolved by the time I woke up the next day. However, on 1/7/21 and 1/8/21 I had pain in my right axilla that I attribute to lymphadenopathy. I did not treat any symptoms and they resolved on their own.
35 2021-01-14 vaccination site pain 1st - minimal pain right deltoid area at vaccination site; This is a spontaneous report from a conta... Read more
1st - minimal pain right deltoid area at vaccination site; This is a spontaneous report from a contactable consumer (patient herself). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Flo140, expiry date: 31Mar2021), via an unspecified route of administration in the right arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine, vitamin c (ascorbic acid) (VITAMIN C), and colecalciferol (VITAMIN D). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient experienced 1st - minimal pain right deltoid area at vaccination site on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Dec2020. Clinical outcome of the event was unknown.
35 2021-01-14 injection site redness, injection site swelling Heart palpitations Weakness Sore throat Low grade fever Lymph node swelling Arms soreness Inje... Read more
Heart palpitations Weakness Sore throat Low grade fever Lymph node swelling Arms soreness Injection site redness and swelling
35 2021-01-14 vaccination site pain Injection site soreness; Pregnant; Pregnant; Pregnant; This is a spontaneous report received from a ... Read more
Injection site soreness; Pregnant; Pregnant; Pregnant; This is a spontaneous report received from a contactable pharmacist (who is also the patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283), intramuscular in left arm, on 09Jan2021 12:15, at single dose, for COVID-19 immunization, in her workplace clinic. The patient medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient is pregnant. Last menstrual date was on 12Jun2020, gestational period is 30 weeks and delivery date will be on 19Mar2021. The patient experienced injection site soreness on 09Jan2021 at 12:15. No treatment was given for the event. The patient did not have COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The outcome of the event vaccination site pain was recovering.
35 2021-01-14 vaccination site redness, vaccination site warmth, vaccination site pain Joint pain; Low grade fever; Nausea; Redness at injection site; Pain at injection site; Warmth at in... Read more
Joint pain; Low grade fever; Nausea; Redness at injection site; Pain at injection site; Warmth at injection site; Mild swelling in distal hand of injection; Moldy swollen axillary lymph nodes; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021 16:00 at the 35 years old at single dose for COVID-19 immunization. The medical history included PCOS, depression. The patient was not Allergies to medications, food, or other products. The concomitant medications were bupropion and venlafaxine. The patient previously took first dose BNT162B2 (lot number EK5730) on 21Dec2020 at 35 years old at Left arm for COVID-19 immunization. On 08Jan2021 08:00 the patient experienced Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes. There was no treatment received for the adverse events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes was not recovered. The information on the batch number has been requested.
35 2021-01-14 itchy skin Lips swelling, itching on neck, increased BP rapid response called received epi pen 0.3mg in vacci... Read more
Lips swelling, itching on neck, increased BP rapid response called received epi pen 0.3mg in vaccine clinic went to ED, received steroids, diphenhydramine, famotidine - monitored for 4 hours then released
35 2021-01-14 vaccination site pain Pain at injection site; Headache; Nausea; Vomiting; Loss of appetite; Fatigue; Chills; This is a spo... Read more
Pain at injection site; Headache; Nausea; Vomiting; Loss of appetite; Fatigue; Chills; This is a spontaneous report from a non-contactable nurse (patient herself). This 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3248), via intramuscular, on 09Jan2021 at 10:30, at single dose in the left arm, for COVID-19 immunisation. The patient was not pregnant. She was vaccinated at hospital, age at vaccination was 35-year-old. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL5730), via intramuscular, on 19Dec2020 at 13:00 at single dose in the right arm. Historical vaccine includes Hepatitis A vaccine (single dose, via an unknown route in the arm left) on 18Dec2020. No medical history was provided. No known allergies. No relevant concomitant medications were provided. The patient was vaccinated at hospital, age at vaccination was 35-year-old. Pre-vaccination and post-vaccination COVID tests were not performed. On 09Jan2021 at 18:00, the patient developed pain at injection site, headache, nausea, vomiting, loss of appetite, fatigue, and chills. The patient was not treated for the events. The patient had recovered from the events on unknown date in Jan2021. No follow-up attempts are possible. No further information expected.
35 2021-01-14 hives Patient felt numbness on her left cheek and developed hives on her forehead within 4 hours or recei... Read more
Patient felt numbness on her left cheek and developed hives on her forehead within 4 hours or receiving the Pfizer covid-19 vaccine. Resolved within 24 hours without treatment.
35 2021-01-14 rash with redness chest tightness red rash around mouth body aches swollen lymph node on right side side of neck
35 2021-01-14 itchy skin, rash macular lips swelling, itching on neck, skin blotchy, increased bp received epipen in covid vaccine clinic ... Read more
lips swelling, itching on neck, skin blotchy, increased bp received epipen in covid vaccine clinic went to ED, received steroids, diphenhydramine, and famotidine, monitored for 4 hours then released
35 2021-01-14 hives red hives; chills; body aches; low fever; This is a spontaneous report from a contactable other heal... Read more
red hives; chills; body aches; low fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on Left arm from 08Jan2021 12:45 to 08Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. On 08Jan2021 at 18:45 (6 hours after receiving vaccine), the patient broke out in red hives, experienced chills, body aches and low fever. The outcome of the events was recovered. No treatment was given for the events. Since the vaccination, the patient has not been tested for COVID-19.
35 2021-01-15 injection site pain I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days... Read more
I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days later. I do not know if the vaccine contributed to my miscarriage but wanted to contribute to the existing data. I had no other side effects or symptoms other than soreness at the injection site. There were no complications with the miscarriage.
35 2021-01-15 skin reaction, hives That morning I had taken amlodipine for the 2nd time in my life to help Raynaud's. Both times I hav... Read more
That morning I had taken amlodipine for the 2nd time in my life to help Raynaud's. Both times I have taken amlodipine now I have felt lightheaded and less cognitively sharp than normal basically the entire day. I received the above Pfizer COVID-19 vaccine around 12:45 PM, within about 3-5 minutes of receiving the vaccine and standing in line to check out I suddenly felt I was going to loss consciousness/collapse so started lowering myself to the ground and then became unconscious and fell. Healthcare staff informed me I was unconscious for about 20-30 seconds. I woke up and initially felt confused, but quickly realized what had happened. Then I felt nauseated, had some stomach cramps and thought I was going to have diarrhea. They considered giving me Epi for possible anaphylaxis, but I requested they observe further for any skin reaction/hives, airway symptoms, etc given I was skeptical the syncope may have been fully or partially related to the amlodipine I took that morning. Symptoms slowly improved over 20-30 minutes, but the lightheaded feeling and nauseated lasted hours. No Epipen, medications, or interventions were needed.
35 2021-01-17 rash Couple hours after the vaccine, experienced elevated temperature, difficulty taking full deep breath... Read more
Couple hours after the vaccine, experienced elevated temperature, difficulty taking full deep breathes (attributed to fatigue). Temperature improved but fatigue and shortness of breathe continued until 1/16/21. a bilater arm rash occurred and employee went to the Emergency Department for an assessment. At this time, she was having chest tightness, shortness of breathe. Lab - troponins elevated. Other labs - within normal limits. Admitted to hospital for observation and discharged next day. Today, during cardiac follow-up appt, was having decreased oxygen saturation levels, increased pulse rate. Admitted again today for obsevation with cncern of acute endocarditis.
35 2021-01-17 skin discolouration, redness, rash Pain in all fingertips with red sunburn-like appearance, white on some tips, generalized joint pain,... Read more
Pain in all fingertips with red sunburn-like appearance, white on some tips, generalized joint pain, shingles-like rash on back. Increased gabapentin to 300 mg daily for 7 days; keep hands warm and do warm water soaks to ease pain, labs drawn, will f/u in one week if s/s have not improved.
35 2021-01-17 itchy skin, redness, hives Started feeling hot, redness all over body and itching that lasted 24 hours. Bilateral neck itching... Read more
Started feeling hot, redness all over body and itching that lasted 24 hours. Bilateral neck itching/redness and hives remain. Still occurring 1 week after vaccine. Worse at night.
35 2021-01-18 hives, redness, itchy skin After second dose of vaccine, about 10 minutes or less of vaccination, I had flushed redness in my a... Read more
After second dose of vaccine, about 10 minutes or less of vaccination, I had flushed redness in my arm, itching, and hives from my neck on the left side, down to my wrist. The symptoms resolved on their own within 10 minutes.
35 2021-01-18 injection site pain At 11:00 pm on 1/14/21, I awakened with chills/rigors. My temperature at that time was 103 F, taken ... Read more
At 11:00 pm on 1/14/21, I awakened with chills/rigors. My temperature at that time was 103 F, taken tympanic. I took Motrin and the fever broke at 2:00 am on 1/15/21. I had an accompanying headache that lingered into the next day. I experienced muscle aches in my shoulders as well as fatigue through 1/18/21. Pain of my right upper extremity (injected arm) lasted from 1/15/21-1/18/21.
35 2021-01-18 hardening, redness Pt. received vaccine to left arm and then returned to work for a half an hour. Went home after shift... Read more
Pt. received vaccine to left arm and then returned to work for a half an hour. Went home after shift. 11 am 1/16/21 noticed body aches everywhere, soreness left arm, bump to left arm along with swelling and redness size of dime. 3 pm pain to left arm pit, lymph nodes, and redness expanded to nickel size, cold compresses applied and Tylenol taken. 530 pm lost ability to move left arm and redness went to size of two quarters side by side. 100.8 fever. Patient reached out admin supervisor. Pt. went into work for 1 pm shift on 1/17/21. Pt. signed into er at work due to expansion of red arm and was given keflex. pt. states that redness hasn't gotten worse since but has not improved. Pt. was not admitted to hospital.
35 2021-01-18 rash SIGNIFICANT UPPER LIP SWELLING 6 DAYS LATER
35 2021-01-18 hives Widespread hives on arms, neck, stomach, hands and legs.
35 2021-01-19 hives 10 days after on 1/18/21, woke up with hives on bilateral shins. Over the last couple of days treat... Read more
10 days after on 1/18/21, woke up with hives on bilateral shins. Over the last couple of days treated for urticaria for unexplained hives. proceeded to extend everywhere but her chest, neck and face. Using daily dose of Claritin, Benadryl for hives, prescribed Pepcid and then using topical cortisone cream and spray calamine lotion, which was told today. Told to report back in 5-7 days.
35 2021-01-19 injection site pain Around 30 minutes after vaccine, I started to feel dizzy and light headed As the day went on, I sta... Read more
Around 30 minutes after vaccine, I started to feel dizzy and light headed As the day went on, I started to get a headache and get very tired. Then around 5 I started to feel intense: Headache Chills/cold Dizzy/light headed/almost fell over several times Muscle weakness, could not carry anything or lift Muscles in face felt like they were melting down/stroke sensation Exhaustion Sore/achy everywhere Tender left arm where shot was Could not think/memory was gone/could not put together a sentence Tightness chest/hard to breath Could not keep eyes open Had to lay down and sleep with long pants long sweater, jacket and 3 blankets I woke up the next morning and some of my symptoms were gone except I still felt tired and had some achy ness, pain and left arm hurt and had shooting pain in joints Shooting severe pain in each joint, laster for 3 days, most severe in joints where I received vaccine but also in wrists, shoulder, elbows, hips, knees, ankles At day 5 my left arm is still sore including muscles around injection site
35 2021-01-19 rash Rash on limbs. Saw PCP. Taking PO Benadryl, and doubled Zyrtec
35 2021-01-19 injection site pain, injection site warmth, injection site swelling body aches, chills, temp 101.4, mild SOB, site pain (site hot and swollen)
35 2021-01-19 injection site pain, injection site swelling received my 2nd shot at 9:24 AM on 01/17/21, Symptoms started 1/17/2021 @ 10:30 PM chills, muscles p... Read more
received my 2nd shot at 9:24 AM on 01/17/21, Symptoms started 1/17/2021 @ 10:30 PM chills, muscles pain, fatigue, headache, fever, arm soreness around injection site as well as swollenness, symptoms subsided as of 01/19/21 around 11:30, 12 noonish
35 2021-01-20 injection site pain 10/10 pain to injection site in left arm, muscle aches all over body, fever, headache
35 2021-01-20 injection site pain Muscle pain Chills Headache Dizziness Heart palpitations Unsure of blood pressure or fever Hot and c... Read more
Muscle pain Chills Headache Dizziness Heart palpitations Unsure of blood pressure or fever Hot and cold Injection site pain
35 2021-01-20 injection site pain Nausea sore throat headache fatigue fever (100.5) body aches change in taste vision changes (cannot ... Read more
Nausea sore throat headache fatigue fever (100.5) body aches change in taste vision changes (cannot see items up close) injection site soreness with sharp pains that radiate down left arm
35 2021-01-20 injection site pain, injection site warmth, injection site swelling Same day: fatigue, nausea Next morning: swollen, tender, red, warm at injection site 2.5x3 inches
35 2021-01-21 injection site hardening, injection site mass, injection site pain, injection site redness A small bump circular in shape is palpable at injections site. Also a red circle formed around (big... Read more
A small bump circular in shape is palpable at injections site. Also a red circle formed around (bigger that the bump), and the area is hardened and painful. The person could not raise the arm either. It last approximately 5 to 7 days to improve symptoms. But still painful for approximately 3 weeks (at the time for the 2nd dose). The situation repeated with 2nd dose in the other arm (will report separately).
35 2021-01-21 rash, redness, itchy skin Severe itch and rash throughout trunk on body and upper right collar bone area. Redness and painful ... Read more
Severe itch and rash throughout trunk on body and upper right collar bone area. Redness and painful itching. Occurring 4+ days. Treatment to take benadryl at night and claritin during the day
35 2021-01-21 rash, itchy skin Within an hour was feeling jumpy, easily startled, foggy thinking, fever (highest 101.6 normal temp ... Read more
Within an hour was feeling jumpy, easily startled, foggy thinking, fever (highest 101.6 normal temp is 97.5), unable to sleep for over 2 days (still haven?t slept partly due to extreme pain), extreme pain all over body especially on left side, racing heart (103 while laying down normal resting is 78), fever would not go down with any amount of fever reducer for 2 days (starting to slowly go down), sore throat, swelling in ankles and feet for two days (is going down now), congested nose, severe ear pain, joint stiffness and extreme ache. Itchy all over body and rash on back. I received the vaccine on 1/20 it is now 1/22 and most are still present though some are getting better very slowly. I did not seek medical care as no one would see me so I just have isolated myself and checked in with a good friend regularly. I just felt it important to report this as no one warns how bad the reaction may be and unlike with the first dose, absolutely no check ins from hospital. I find that to be completely unacceptable.
35 2021-01-21 injection site pain fever, chills, body aches, injection site soreness
35 2021-01-21 injection site redness, injection site swelling, injection site pruritus, injection site pain when I got the vaccine it was puff for 4 days. On the 5th day I noticed that the injection site was ... Read more
when I got the vaccine it was puff for 4 days. On the 5th day I noticed that the injection site was red and plump. I also had a burning itch like a mosquito bite. It got to the size of a tennis ball. I tried to refrain from touching the area as well as scratching the area to not spread.
35 2021-01-22 injection site pain Injection site soreness (1 hour afterward, lasting through the following day and night), muscle sore... Read more
Injection site soreness (1 hour afterward, lasting through the following day and night), muscle soreness and pain (3 hours afterward, worse the next day, abated the evening of 1/21), slight vertigo (1 hour afterward, laying about 2 hours)
35 2021-01-23 itchy skin Progressive full body skin itchiness throughout the day without hives or rash.
35 2021-01-24 itchy rash, rash 15 weeks pregnant female with localized rash on left lower back. Itchy, occasionally painful
35 2021-01-24 itchy skin On Saturday, January 23, 2021 I woke up around 5:30 in the morning with itchy hands and feet, after ... Read more
On Saturday, January 23, 2021 I woke up around 5:30 in the morning with itchy hands and feet, after my second dose/ Just as I did with my first dose- Which subsided with Benadryl. However the second dose was given Thursday, January 21. The progressing of the itchy hands and feet lead to my bottom lip swelling excessively large , my tongue begin to swell, my upper lip begin to swell, my lungs begin to burn in my airway begin to tighten. I took two Benadryl and called my family to call 911 and take me to the emergency room. My blood pressure was very low pulse was very high. I had genital pain and swelling, dizziness , nausea vomiting, and extreme body pain. I was given epinephrine, breathing treatments, steroids, Benadryl, and IV fluids. Labs were drawn and my creatinine was high. After about four hours the swelling has gone down and I was able to go home. I have to take steroids for three days, Benadryl for seven , and famotidine. I have no history of severe allergies, in fact I was tested for food and environmental allergies about a year ago and everything came back negative. I have no history of reacting to any vaccine at any time.
35 2021-01-24 injection site mass, injection site pain Rigors, chills, body aches, fatigue, night sweats, golf ball sized mass at injection site- tender an... Read more
Rigors, chills, body aches, fatigue, night sweats, golf ball sized mass at injection site- tender and painful to touch.
35 2021-01-24 vaccination site swelling, vaccination site hardening, vaccination site itchiness Swelling in left arm on injection site has now become hard and itchy.; Swelling in left arm on injec... Read more
Swelling in left arm on injection site has now become hard and itchy.; Swelling in left arm on injection site has now become hard and itchy.; Swelling in left arm on injection site has now become hard and itchy.; This is a spontaneous report from a contactable Other HCP (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, on 08Jan2021 15:30 at single dose on left arm for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The patient has no other vaccine in four weeks. The patient had no Other medications in two weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. The patient had Swelling in left arm on injection site had now become hard and itchy on 09Jan2021. No treatment was received for all events. The outcome of the events was not resolved.
35 2021-01-24 redness, itchy skin Swelling, redness to about 1.5 inches by 1 inch. Warm to touch. Sometimes itches
35 2021-01-24 injection site swelling, injection site pain Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized... Read more
Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized pain and swelling at injection site
35 2021-01-24 injection site redness, injection site swelling Within 10 minutes I was numb with a hot, tingly sensation from my left knee up to my neck and my lef... Read more
Within 10 minutes I was numb with a hot, tingly sensation from my left knee up to my neck and my left wrist up my arm to my neck. Then I felt like I had been hit in the head with a bat, but the pain migrated from side to side in my head. It was a very strange feeling. The hot, tingly numbness lasted about 45 minutes to an hour, the headache began to subside after 2 hours. The next day I had a little raised redness and the injection site and a bad headache, but was otherwise fine. At the vaccination site they strongly advised I go to the ER, which I did. I have no history of vaccine reaction.
35 2021-01-25 itchy skin Minor itching of arms (not at injection site) and around lips.; Minor itching of arms (not at inject... Read more
Minor itching of arms (not at injection site) and around lips.; Minor itching of arms (not at injection site) and around lips.; This is a spontaneous report from a contactable consumer. A 35-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date not reported), via an unspecified route of administration at the right arm on 12Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included Latex allergy, chronic migraine, seasonal allergies, and had previous anaphylaxis due to insect stings. Concomitant medication included sumatriptan. The patient previously took Tylenol and experienced allergy. It was reported that the patient experienced minor itching of arms (not at injection site) and around lip. It was reported that the event started shortly after the thirty minute (15:15) wait after injection and ended around an hour after injection (15:45). Patient further reported that she has previous history of anaphylaxis due to insect stings. It was not bad enough to seek treatment and it took a bit to realize that it wasn't just a result of her worrying, but it was noticeable. No hives, no redness. Patient did not feel the need to seek treatment, but she did monitor symptoms until they eased. Vaccine was from a vial with no latex, due to existing minor allergy. No treatment was given to the patient in response to the event. There was no COVID prior to vaccination and no COVID test post vaccination. The patient recovered from the event on 12Jan2021 at 13:45.
35 2021-01-25 vaccination site pain Moderate soreness at injection site; This is a spontaneous report from a contactable other hcp (pati... Read more
Moderate soreness at injection site; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK 5730), via an unspecified route of administration on 19Dec2020 08:15 at 35 years old at left arm at single dose for covid-19 immunization. Facility type vaccine was doctor's office/urgent care. NO other vaccine in four weeks. Medical history included migraine. No known allergies. Concomitant medication included sumatriptan succinate (IMITREX) 100 mg PRN (As needed) for migraines, ethinylestradiol, norgestimate (SPRINTEC) 28 day. The patient experienced moderate soreness at injection site only for 2 days on an unspecified date. No Covid prior vaccination and covid was not tested post vaccination. The outcome of the event was recovered.
35 2021-01-25 injection site pain PAIN AT INJECTION SITE- MODERATE PAIN FOR 24 HRS; HEADACHE-MODERATE 24 HRS; FATIGUE 24 HRS
35 2021-01-25 itchy skin, rash Systemic: Rash (other than injection site)-Mild, Systemic: Other- Shortness of breath, itching, thro... Read more
Systemic: Rash (other than injection site)-Mild, Systemic: Other- Shortness of breath, itching, throat tightening; symptoms lasted 1 day
35 2021-01-25 hives, itchy skin lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous re... Read more
lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: E-1284), intramuscular in the right arm on 12Jan2021 at 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergy to IV contrast. The patient was not pregnant at the time of vaccination, had no other vaccine within four weeks, and did not have COVID prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID; reported as other medication within 2 weeks). On 12Jan2021, less than 5 minutes after administration (also reported as at 02:15PM), the patient experienced lightheadedness, throat became scratchy, tongue felt thick, hives, and itching. These were resolved with Benadryl, Pepcid, Zyrtec, and IM steroids (also reported as PO and IM medications). It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not tested positive for COVID post vaccination. Outcome of the events was recovered/resolved (also reported as recovering). Information on the lot/batch number has been requested.
35 2021-01-26 injection site swelling, injection site pain, injection site redness, injection site discolouration Blue dots around injection site, swelling, redness, pain.
35 2021-01-26 injection site redness Immediate onset of tachycardia and flushing, resolved after 5 minutes. 30-min delayed onset of metal... Read more
Immediate onset of tachycardia and flushing, resolved after 5 minutes. 30-min delayed onset of metallic taste in the mouth, resolved after 2 hours. 8-hours delayed onset of 8/10 arm pain and 8/10 fatigue, arm pain resolved after 4 days, fatigue improved after 3 days but has bet to resolve. 24-hours delayed onset of circular erythema around the injection site, approximately 6' in diameter, resolved after 9 days.
35 2021-01-26 injection site pain injection site soreness (1/26/21 to current), axillary swelling on side of injection (1/26/21 to cur... Read more
injection site soreness (1/26/21 to current), axillary swelling on side of injection (1/26/21 to current), fever (1/26/21 to 1/27/21), body aching (1/26/21 to current), chills (1/26/21 to 1/27/21), intense fatigue (1/26/21 to current), feeling cognitively fuzzy (1/26/21 to current) awaiting resolution of fatigue, cognitive fuzziness, and axillary swelling no treatment at this time unless these symptoms do not resolve
35 2021-01-27 vaccination site pain Breakthrough bleeding/spotting menses; soreness at injection site; This is a spontaneous report from... Read more
Breakthrough bleeding/spotting menses; soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL0142, expiry: unknown), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose in a hospital for COVID-19 immunization. Medical history included Alport's, alopecia areata and eczema. The patient has no known allergies. Concomitant medications included lisinopril and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 23Dec2020 at 10:00 in the left arm for COVID-19 immunization and experienced fatigue, muscle aches, breakthrough bleeding/spotting menses within 12 hours of dose and soreness at injection site within 12 hours of dose. On an unspecified date, the patient experienced breakthrough bleeding/spotting menses within 12 hours of dose and soreness at injection site within 12 hours of dose (worst with first dose, mild with second dose). The patient was tested for Covid post vaccination via nasal swab using SARS-COV-2 BY PCR (2019-NCOV) on 30Dec2020 which was negative. The patient was also tested with SARS-COV-2 IGG (blood test) on 09Jun2020 which was negative as well. The events were not treated. The outcome of the events was unknown.
35 2021-01-27 vaccination site pain Breakthrough bleeding/spotting menses; soreness at injection site; fatigue; muscle aches; This is a ... Read more
Breakthrough bleeding/spotting menses; soreness at injection site; fatigue; muscle aches; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 10:00 at single dose in Left arm for COVID-19 immunization. Medical history included Alports, Alopecia Areata, eczema, all from an unknown date and unknown if ongoing. There were no known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC), lisinopril. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient experienced Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches on 23Dec2020 20:30. No treatment received for all reported events Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches. The patient underwent lab tests which included blood test for covid-19 which named SARS-COV-2 IGG on 09Jun2020 was with result Negative and covid-19 test which named SARS-COV-2 BY PCR (2019-NCOV) via Nasal Swab post vaccination on 30Dec2020 was with result Negative. The outcome of the events was recovered on an unspecified date.
35 2021-01-27 vaccination site pain Fever; chills; muscle aches; pain at injection site; headache; chest pain; This is a spontaneous rep... Read more
Fever; chills; muscle aches; pain at injection site; headache; chest pain; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 12Jan2021 at single dose for covid-19 immunisation. Medical history included sulfa allergy, canteloupe allergy. The patient's concomitant medications were not reported. No any other medications the patient received within 2 weeks of vaccination. The patient previously received 1st dose of BNT162B2 (lot# EJ1685) via intramuscular in right arm on 22Dec2020 13:00 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, muscle aches, pain at injection site, headache, chest pain on 12Jan2021 17:00. The patient was not pregnant. No treatment received for the events. The outcome of events was recovered on an unspecified date of Jan2021. This case was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
35 2021-01-27 hives Headache, dizzy, MTN, tachycardia, uticardia
35 2021-01-27 hives Hives starting from my head down to face and chest; This is a spontaneous report from a non-contacta... Read more
Hives starting from my head down to face and chest; This is a spontaneous report from a non-contactable Other HCP. This Other HCP reported for a 35-year-old female patient that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 12Jan2021 04:45 PM at single dose for COVID-19 immunization. Medical history included known allergies: latex and avocado. Concomitant drugs were not reported. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 12Jan2021 07:30 PM, patient had hives starting from her head down to face and chest. Diphenhydramine (BENADRYL) was given as treatment. Outcome of event was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
35 2021-01-28 shingles 35 year old woman, history of shingles 8 years ago. Developed shingles rash in same distribution as ... Read more
35 year old woman, history of shingles 8 years ago. Developed shingles rash in same distribution as she had 8 years.ago 9 days after receiving second dose of pfizer-biontech covid 19 vaccine.
35 2021-01-28 injection site pain, injection site swelling 830am vaccinated, 12pm mild-mod headache and fatigue (sore arm at inj site), persisted, 10pm worse ... Read more
830am vaccinated, 12pm mild-mod headache and fatigue (sore arm at inj site), persisted, 10pm worse headache, fatigue, mild body aches started at shoulders and upper back and neck, able to fall asleep by 11pm, woke up at 1am in severe pain, migraine, head pressure, joint pain of every joint in my body, hands were swollen, felt like my joints were pulsating, very painful to bend or move any of my joints, muscle aches so bad any tiny movement hurt, even lying still hurt my back because of the pressure onto my back, even my spine felt tender, stiff neck I could barely look down or up but i could turn head left and right, stomach ache and nausea, my arm that was given vaccine was severely in pain and tender to touch and swollen at area of inj. There was light headed sensation w/ movement and position, pressure in my head felt like my head was going to explode and my eyes were burning. Because so severe, I took 1000mg tylenol, lathered by entire body in eucalyptus oil and peppermint on my hands, I was able to fall asleep at 3am but it was restless sleep I kept waking up because any movement I made in bed I'd have severe pain. 6am I felt moderately better all symptoms 50% improved, applied eucalyptus oil on again, started work at 730am I could barely function at work I have brain fog, just thinking focusing eyes concentrating makes migraine worse, +photopphobia, phonophobia, just typing is very hard to do because it hurts my joints, the vertigo worsened and the slightest looking down to the keyboard while typing causes lightheaded sensation. No improvement and it's now almost 1pm. I didn't take any pain medication or apply any essential oils.
35 2021-01-28 itchy skin, rash ? Day 10 after vaccine #1 upper lip swelling AKA angioedema ? Day 6 post vaccine #2 lower right lip ... Read more
? Day 10 after vaccine #1 upper lip swelling AKA angioedema ? Day 6 post vaccine #2 lower right lip and upper right lip swelling. Scratchy throat ? Day 10 post vaccine #2 wheezing like an asthma attack ? Day 12 post vaccine #2 Left, lower lip swelling, tingling in my tongue ? itchy for 2 weeks, 14 days post vaccine #2. Developed a sporadic, ever changing rash ? Day 16 post vaccine #2 a different, new rash
35 2021-01-28 skin warm Client report receiving COVID vaccination on 01/28 at 11:40, adverse reaction on left index /pointer... Read more
Client report receiving COVID vaccination on 01/28 at 11:40, adverse reaction on left index /pointer finger having moderate swelling. Has pain with bending it, and it is warm to the touch. Has not contacted a medical provider or had any treatment. Per client her mother is a nurse and told her to continue to monitor her finger. At this time, client believes the swelling is worse but not to the need to see a medical provider.
35 2021-01-28 injection site hardening, redness Fever, body aches, headache, redness swelling and firmness at injection site (resembling cellulitis)... Read more
Fever, body aches, headache, redness swelling and firmness at injection site (resembling cellulitis) as well as lymphedema to right armpit.
35 2021-01-28 itchy rash, rash papular, rash From the doctor that saw me in the ED: Patient received the second dose of her Covid vaccine on Janu... Read more
From the doctor that saw me in the ED: Patient received the second dose of her Covid vaccine on January 12. 5 days later, on January 17, she had onset of a diffuse pruritic macular papular rash on arms, chest and back and mildly on her face. 2 days ago, she was seen in urgent care and given prednisone and antihistamines. She has had no improvement. No mucosal involvement. No fevers or chills. No joint or body aches. No new exposures, medications. She is the only one in her house with the symptoms. She works as a nurse, but has had no known exposures.
35 2021-01-28 hives Initially severe pain in left arm. Within 24 hours post vaccine hives on thigh and elbow of arm that... Read more
Initially severe pain in left arm. Within 24 hours post vaccine hives on thigh and elbow of arm that received vaccine. By Friday hives had spread to stomach, chest, face and both arms
35 2021-01-28 injection site hives, injection site pruritus Soreness, no swelling no redness,at injection site next day after injection. Then fine. on day 9 af... Read more
Soreness, no swelling no redness,at injection site next day after injection. Then fine. on day 9 after injection had itching at the injection site and noticed 1 large hive at the injection site, present for 1-2 hours, then resolved. every day thereafter had noticed 1-4 small hives in various locations on arms and face that come and go
35 2021-01-28 rash, injection site swelling Troponin, which is a cardiac enzyme or a heart test to be high; test continued to stay high for the ... Read more
Troponin, which is a cardiac enzyme or a heart test to be high; test continued to stay high for the 24 hours when they have done three different test at 8 hours apart; I might have myocarditis which is inflammation of the heart muscle as a result of the vaccine; I am having side effects affecting the heart because my cardiac enzymes are high; Rash that can happen from low platelet on both of my arm, for which I came to the emergency room; Rash that can happen from low platelet on both of my arm, for which I came to the emergency room; I am having side effects affecting skin because I am having rash; I am side effects affecting the immune system because my lymph nodes are enlarged; I have swelling at the site of injection; My lungs because I was wheezing; I was having lung symptoms; I have any irregular rhythm; I started having low grade fever and myalgia; I had similar low grade fever and myalgia with my first dose; I started having low grade fever and myalgia; I had similar low grade fever and myalgia with my first dose; I started having high grade fever, maximum temperature of 101.5 degree Fahrenheit; Wheezing; Dyspnea on excursion which is basically shortness of breath when I go up and down on the stairs; Chest tightness; This is a spontaneous report from a contactable Physician (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included asthma exercise induced from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on unknown date and experienced low grade fever and myalgia. On 15Jan2021 the patient experienced Dyspnea on excursion which is basically shortness of breath when I go up and down on the stairs; Chest tightness; I started having high grade fever, maximum temperature of 101.5 degree Fahrenheit; Wheezing. On 16Jan2021 the patient experienced rash that can happen from low platelet on both of my arm, for which I came to the emergency room (hospitalization). On unknown date the patient experienced Troponin, which is a cardiac enzyme or a heart test to be high; test continued to stay high for the 24 hours when they have done three different test at 8 hours apart (hospitalization); I might have myocarditis which is inflammation of the heart muscle as a result of the vaccine (hospitalization); having side effects affecting the heart because my cardiac enzymes are high (hospitalization); I have any irregular rhythm; I started having low grade fever and myalgia; I had similar low grade fever and myalgia with my first dose; I am having side effects affecting skin because I am having rash; I am side effects affecting the immune system because my lymph nodes are enlarged; I have swelling at the site of injection; My lungs because I was wheezing; I was having lung symptoms. The patient underwent lab tests and procedures which included blood test: unknown results on unknown date; body temperature: 101.5 fahrenheit on 15Jan2021, chest x-ray: unknown results on unknown date; echocardiogram: unknown results on unknown date; EKG: unknown results on unknown date, cardiac enzyme: high on 16Jan2021, platelet count: low on unknown date . The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-29 injection site pain I had a really sore arm for 4-5 days at the injection site. I couldn't lift my injected arm over my... Read more
I had a really sore arm for 4-5 days at the injection site. I couldn't lift my injected arm over my head the next day after the injection due to stiffness and pain. The pain improved over time. I also had intermittent chills the evening after receiving the vaccine. I had an episode of diaphoresis the next morning at work. I checked my temperature when I was having chills and I had no fever.
35 2021-01-29 injection site pain Injection site pain, followed by body aches, fever of 100.0, chills, nausea and headache.
35 2021-01-29 injection site warmth, injection site redness, injection site swelling Red, hot, swollen itchy at injection site, only occured 8 days after, was fine before hand
35 2021-01-31 rash with redness 12 hours later I had a full red body rash, red bumps, swollen hands, inflamed wrists, flu like sympt... Read more
12 hours later I had a full red body rash, red bumps, swollen hands, inflamed wrists, flu like symptoms, dizziness, nausea, headaches, swollen tounge, extreme exhaustion, a feeling of being completely out of it, otherworldly. I should have gone to the hospital but I have an extreme medical phobia so I stayed up and made sure my tounge didn't swell any further. The next morning my tounge was normal ish, the red rash was gone and my hands and wrists were back to normal. 5 days later and I am still experiencing headaches, my throat feels sore and a little bit of a hard time swallowing, extreme exhaustion, dizziness, nausea, a feeling of being completely out of it, otherworldly.
35 2021-01-31 sensitive skin At approximately 11:45 a.m. on the date of the injection my hands became freezing cold. This lasted ... Read more
At approximately 11:45 a.m. on the date of the injection my hands became freezing cold. This lasted for approximately 16 hours. My skin has since been very sensitive to touch, this includes skin on my face, arms, hands, and chest. I am very sensitive to temperature changes, especially cold. My nervous systems feels very sensitive, especially my hands. Touching cold items (refrigerator, outside, etc.) makes me shiver. I have also been experiencing a covid fog. I do not feel like myself and am not experiencing joy. I cry daily for no reason.
35 2021-01-31 injection site pain Received COVID-19 Vaccine on Wednesday 01/27/2021. On Thursday 01/28/2021; I woke up with a Severe H... Read more
Received COVID-19 Vaccine on Wednesday 01/27/2021. On Thursday 01/28/2021; I woke up with a Severe Headache; Fatigue; and site pain. My temp was 99.5.
35 2021-01-31 hives, redness, itchy skin, rash Received first dose of Pfizer covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the ob... Read more
Received first dose of Pfizer covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the observation room for 5 minutes when she developed itching on hands and then noticed hands were red, spread to arms, then chest and neck started itching. Took vitals, blood pressure was high, she attributes to anxiety, acknowledges that she was nervous about getting vaccine. Then within 10 minutes from vaccination started getting hives and throat started feeling swollen and difficult to swallow. They gave her epipen - after receiving epi she was able to swallow within 5 minutes, hives and rash were gone but still somewhat itchy. Was sent to ER - was given steroids - symptoms resolved. Today she is feeling normal. She has never had a reaction like this before. Only known allergy is to cats. Never had allergic reaction or previous immunizations or medications. Started Wellbutrin 2 weeks ago but has been on this med before, not new. This is a 35-year-old female presents for an allergic reaction after receiving her 1st coronavirus vaccination. She was given IM epinephrine EN route. On my exam she appears in no acute distress. Blood pressures are stable. She is not tachycardic. She has normal O2 saturations. She states she still having some itchiness to the arms and behind her ears. She states her throat still feels little scratchy but is not having go difficult time breathing. Denies associated chest tightness or shortness of breath. Denies any abdominal pain, nausea vomiting. Denies any prior allergic reactions to other vaccines are medications. Her face does appear to be a bit flushed. She was given IV Solu-Medrol, IV Benadryl and IV Pepcid. She was observed for 2 hours and has significant improvement of her symptoms. Given a she was discharged home with instructions to use Benadryl as needed for any other allergic symptoms. She is instructed to return for increasing shortness of breath or throat tightness. She is agreeable this plan and discharged home.
35 2021-01-31 hives, itchy skin, redness Received first dose of covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the observati... Read more
Received first dose of covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the observation room for 5 minutes when she developed itching on hands and then noticed hands were red, spread to arms, then chest and neck started itching. Took vitals, blood pressure was high, she attributes to anxiety, acknowledges that she was nervous about getting vaccine. Then within 10 minutes from vaccination started getting hives and throat started feeling swollen and difficult to swallow. They gave her epipen - after receiving epi she was able to swallow within 5 minutes, hives and rash were gone but still somewhat itchy. Was sent to ER - was given steroids - symptoms resolved. 35-year-old female presents to the ER for evaluation allergic reaction. Symptoms started approximately 30 minutes after receiving her 1st COVID vaccination. She states she became very flushed and itchy and began having some throat discomfort. She was given a IM injection of epinephrine and sent to the ER by EMS for further evaluation. She states she still having some itchiness to the arms and behind her ears. She states her throat still feels little scratchy but is not having go difficult time breathing. Denies associated chest tightness or shortness of breath. Denies any abdominal pain, nausea vomiting. Denies any prior allergic reactions to other vaccines are medications. 35-year-old female presents for an allergic reaction after receiving her 1st coronavirus vaccination. She was given IM epinephrine EN route. On my exam she appears in no acute distress. Blood pressures are stable. She is not tachycardic. She has normal O2 saturations. Her face does appear to be a bit flushed. She was given 125 mg of IV Solu-Medrol, 50 mg IV Benadryl and 20 mg IV Pepcid. She was observed for 2 hours and has significant improvement of her symptoms. Given a she was discharged home with instructions to use Benadryl as needed for any other allergic symptoms. She is instructed to return for increasing shortness of breath or throat tightness. She is agreeable this plan and discharged home.
35 2021-01-31 injection site pain Received vaccine at work around 10:30am on 1/19/21. Around 01:00am on 1/20/21 I woke up with my arm ... Read more
Received vaccine at work around 10:30am on 1/19/21. Around 01:00am on 1/20/21 I woke up with my arm feeling as if it were on fire. My entire shoulder locked up and my ROM has been limited since receiving the vaccine. It continues to get worse as of 2/1/21.
35 2021-02-01 injection site pain 2nd vaccine started at 8pm soreness around the injection site, headache, minor body aches, chills an... Read more
2nd vaccine started at 8pm soreness around the injection site, headache, minor body aches, chills and they progressed over the night, the headache wasn't getting better with Tylenol, at about 2am it was pretty severe I couldn't sleep after that, I used cold wash clothes to help with fever that was about 101. The next morning my fever was low grade with Tylenol. I called employee help line and they told me to rest. All symptoms were within the first 48 hours and I was completely fine after that 37 Weeks pregnant - due date: Feb 14, 2021, Low risk, no issues, tests are all normal
35 2021-02-01 injection site redness Around 4PM on the 14th I started with chills. 2 hours later I took my temp and it was 102.8F ad I ha... Read more
Around 4PM on the 14th I started with chills. 2 hours later I took my temp and it was 102.8F ad I had really bad fever, chills, muscle aches, nausea and then the right breast pain started again (around 3AM). I noticed the redness on the same location as it happened with the 1st dose. I had a clogged duct this time as well. On the right breast. The symptoms with the second dose were much worse/stronger than the 1st dose. I consulted with urgent care over the phone and was prescribed Keflex. Symptoms subsided in about 3 days.
35 2021-02-01 injection site pain Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection ... Read more
Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection site. patient then stated she felt tingling in her hands, feet, and mouth. Patient also stated that she felt her heart racing. BP 172/103, HR 149, SPO2 100% on room air. Denies SOB and difficulty breathing. Pt was transferred to ED. In ED was given oral prednisone and diphenhydramine. Assessment for possible drug reaction, not thought to be anaphylaxis, with mild anxiety contributing. Patient monitored and discharged in stable condition.
35 2021-02-01 itchy skin, rash macular, rash Rash that started in armpit and went across chest and back. Worse on left side. Rash is blotchy ,... Read more
Rash that started in armpit and went across chest and back. Worse on left side. Rash is blotchy , itchy, and burns. Also had diarrhea. Symptoms started on 1/29/2021 and have started to improved.
35 2021-02-01 redness So, for the 1st dose it started early morning of 12/24 maybe even on the 23rd I had a kind of chills... Read more
So, for the 1st dose it started early morning of 12/24 maybe even on the 23rd I had a kind of chills, a pain sensation in my arm, temp on 12/24/20 was 100.3F I also developed a pain on my right breast - developed mastitis. I started antibiotics (Dycoclocilin)that afternoon after contacting my PCP. I am a breastfeeding mother. There was redness on the right breast and pain. Some muscle aches. Fatigue. It lasted about 3 days or so.
35 2021-02-01 injection site tingling Symptoms: tingly arm at injection site, numb and tingly and sore/swollen throat, tongue, lips. Dizzy... Read more
Symptoms: tingly arm at injection site, numb and tingly and sore/swollen throat, tongue, lips. Dizzy, high bp and tachycardia, heart palpitations. All within 15 minutes. Then at the ER deep cough, hoarse and difficulty speaking.
35 2021-02-01 injection site pain ached over body, equilibrium off, red eyes double vision, lasted 2 days pain injection site left ar... Read more
ached over body, equilibrium off, red eyes double vision, lasted 2 days pain injection site left arm last almost one week
35 2021-02-02 injection site pain, skin warm, skin discolouration 11:23am Pt C/O feeling hot and clammy and nausea, skin pink, warm and clammy, denies SOB, and chest ... Read more
11:23am Pt C/O feeling hot and clammy and nausea, skin pink, warm and clammy, denies SOB, and chest tightness, no hives or itching present, A & Ox3 resps reg. No distress noted. This is her 1st shot of Covid 19 vaccine. Right arm BP 80/38 P-104 PO 99% sweatshirt taken off, chair reclined, knees bent up. Charge nurse RN summoned. 11/25am BP 75/37 P71, PO 99%, consulted RN about giving Benadryl and she since she did not have hives, and is A& Ox3 to hold off. RN has access to med dispenser. Pt states she takes Ativan for anxiety at night na Lamictal for mood stability. 11:26a,m BP changed to right arm due to pain to injection site, site asymptomatic. BP 70/31 P 70 PO 99%, ice packs to neck and forehead. No Benadryl per RN. 11:28 BP 101/60 P 98 PO 100% continue ice packs. 11:30am BP 95/59 P 92 PO 100%. 11:36am BP 97/59 P 82 PO 100% decreased nausea states she is feeing more normal. 11:39 BP 93/61 P 80 PO 100% continues to be A&O x3 states she feels fine. 11:42 am BP 103/67 p 84. 11:45am BP 110/77 P 88. 11:51am BP 96/66 P 88 sitting up right with feet down, given water and crackers. 12:04 pm BP 105/64 P 83 PO 100% continue to feel better. 12:10 pm BP 98/67 P 86 states she still feels weak. 12:20pm BP 104/60 P 86 . 12:23pm BP 93/63 P 85 while standing. 12:34pm BP 95/55 P 91 She states she feels back to normal and ready to go. Skin cool, dry and less pink. Instructed if she begins to feel light headed while walking to stop and lay down with feet bent up, and if driving to pull over, call emergency services and lay down. Pt states she understands. 12:35 Pt walked out without difficulty.
35 2021-02-02 injection site pain 2 hours after vaccine I developed headache, burning/hot feeling in eyes and fatigue. That night I ha... Read more
2 hours after vaccine I developed headache, burning/hot feeling in eyes and fatigue. That night I had chills, fever, full body joint pain, nausea, heavy head feeling, muscle pain and left arm pain at injection site. The next day I had severe painful swollen lymph nodes to left clavicle and under left arm. Second night I had ongoing fever, chills, muscle pain, fatigue and overall feeling under the weather. 7 days after I had right leg pain from thigh to ankle. Till today I still have generalized fatigue and swollen lymph nodes (although they are smaller that before)
35 2021-02-02 injection site pain Right under arm/armpit lymphnode swelling and soreness: 12 hours post-vaccine, ongoing (currently at... Read more
Right under arm/armpit lymphnode swelling and soreness: 12 hours post-vaccine, ongoing (currently at 19 days post-vaccine). Soreness and swelling under arm have improved, but not resolved (previously 8/10 pain, currently 2/10). Starting ~5 days post-vaccine, appears to have triggered carpal tunnel syndrome in right arm/wrist/hand, which is unresolved for ~2 weeks now. Upper right arm soreness at injection site: 12 hours post-vaccine, lasted 3 days Headache starting 12 hours post-vaccine, lasted ~8 days Fever up to 102 degrees F (started using Tylenol after 24 hours to reduce fever), with total body aches (myalgia and arthralgia, and chills): 12 hours to 72 hours post-vaccine12 hours to 72 hours post-vaccine Mild nausea 12 hours post-vaccine, lasted ~4 days post-vaccine
35 2021-02-02 rash, hives, itchy skin This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female p... Read more
This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 14Jan2021 14:30 in left arm at single dose for covid-19 immunization. Medical history included known allergies: seasonal allergies-pollen/dust and other medical history was none. No other vaccine was received in four weeks. Concomitant medication in two weeks included cetirizine, quercetin, ascorbic acid, sodium ascorbate (LIPOSOMAL VITAMIN C). Facility type vaccine was public health clinic/veterans administration facility. 7 minutes post injection, patient had hives/severe itching about 1x1 inch patch above left elbow. 40 minutes post injection, patient experienced swelling of left arm and both calves and facial flushing, mild rash on day 3- 4 on both arms. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Patient received the treatment of oral diphenhydramine hydrochloride (BENADRYL) 50 MG; famoditine IV (intravenous) for events. Outcome of events were recovered with sequel in Jan2021.
35 2021-02-03 itchy skin, hives, rash 30 minutes after injection - muscle spasms in both arms from wrists to elbows 45 minutes after injec... Read more
30 minutes after injection - muscle spasms in both arms from wrists to elbows 45 minutes after injection - itching, warmth, rash, hives on face, neck, chest, arms, and legs 1 hour after injection - eyes watering and inner ears itching and stinging; itching all over body 4 to 5 hours after injection - tongue swelling and tingling
35 2021-02-03 injection site redness, injection site pain Fever (about 102*), major chills, major headache, fatigue, pain at injection site, redness at inject... Read more
Fever (about 102*), major chills, major headache, fatigue, pain at injection site, redness at injection site, minor nausea. Most of the symptoms were better by 2/4/2021 but still had a headache, redness at injection site, and fever the second day. Took acetaminophen the night of 2/3/2021 for fever and headache which helped a lot
35 2021-02-03 shingles I broke out in shingles; Relevant medical history: type 1 diabetes mellitus and lupus; Relevant medi... Read more
I broke out in shingles; Relevant medical history: type 1 diabetes mellitus and lupus; Relevant medical history: type 1 diabetes mellitus and lupus; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 08Jan2021 at 11:00 to 11:45 (as reported), at single dose, for COVID-19 immunization, in the hospital. Medical history included ongoing type 1 diabetes mellitus (diagnosed at 8 years old, maybe around 1993-1994), lupus from 2004 and ongoing, TTP (blood clotting disorder) from 2019 and ongoing and allergies to sulfa drugs. There were no concomitant medications. Historical vaccine included flu shot for immunization which she believes that was well before 4 weeks. The patient stated, 'My doctor wanted me to call and get information. I received my first vaccine but a week later I broke out in shingles and I'm due to get my second dose in a week or so. Any advice on that? My doctor suggesting putting the second dose off for a few weeks. Does it become ineffective? Is there a timeline? What is the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine, and can I receive it earlier or later than 3 weeks?". The patient reported that she received the first dose of the COVID vaccine. A week after, she came down with shingles. She was wondering if she could get the second dose after coming down with shingles. She clarified that on 15Jan2021 (Friday), she went with what she initially thought was a pinched nerve. She had radiating pain starting from her shoulder coming down into her hands and fingers. She had the rash probably on Friday (22Jan2021). She then started getting a small blister/rash on 23Jan2021. On 24Jan2021, she returned to the Urgent Care and the rash had spread at that point and they were pretty sure it was the shingles virus. She reported she had gone to Urgent Care over the weekend twice, they suspected that was what it was. She saw the doctor on 19Jan2021 (yesterday) and gave the official diagnosis of shingles. The outcome of the events was unknown.
35 2021-02-03 injection site pain I got the shot on a Friday night at 5pm. I experience the arm pain in my left arm through out the to... Read more
I got the shot on a Friday night at 5pm. I experience the arm pain in my left arm through out the top of my arm , by the end of that night. By Saturday evening most of the pain was gone from that site. Late Saturday night I started noticing some pain in the arm pit on the left arm, didn't think much about it. By Sunday mid morning the pain was just getting more severe. Started to pay close attention to the side effects of the vaccine to realize that I most likely had swollen lymph nodes. The pain continued through the following Wednesday, when the pain started to not be as bad. I still to this day have some pain in the lymph nodes. I have contacted my doctor and was told to just monitor the site to make sure nothing is worse. That these reactions are common. I also have some soreness in my upper arm under where the shot was given, that I'm not sure if it is from the shot or the muscle compensating from the soreness of the swollen lymph nodes.
35 2021-02-03 injection site swelling, injection site pain Mild headache, soreness and swelling of the injection site, fatigue for 24-48 hours.
35 2021-02-03 itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported that on 1/06/2021 they were admini... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported that on 1/06/2021 they were administered the vaccine and suddenly developed dry throat, itching at the roof of their mouth and a headache. Thought she needed a drink of water so she didn?t ask for help. She went home. Then her right eye began to itch. Then within the next 20 minutes she developed itchiness all over and her lips became tingly and slightly swollen. Vaccine recipient reported that they had a telehealth appointment occupational health and was prescribed prednisone. Then around 1115 am, she became dizzy and her heart rate increased to the 110s and developed chest tightness. By 1130 am she developed a scratchy throat and dry cough. They became dizzy after the phone call and told a family member to take them to the ED for worsening symptoms. While in the ED they received prednisone and Pepcid. During re-evaluation she improved and was discharge to home.
35 2021-02-03 hives Throat was itching and felt very full; Throat was itching and felt very full; hives on arm; hot swea... Read more
Throat was itching and felt very full; Throat was itching and felt very full; hives on arm; hot sweats; Extreme fatigue; lymphadenopathy in armpit and injection site; lymphadenopathy in armpit and injection site; headache; body aches; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 14Jan2021 09:45 at single dose for COVID-19 immunisation. Medical history included seasonal allergies and depression. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the left arm on 24Dec2020 12:00 at single dose for COVID-19 immunisation. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC) and a birth control pill (unspecified). It was reported that 10 minutes after the second dose, on 14Jan2021 09:55, the patient's throat was itching and felt very full, hives on arm, hot sweats, which went away with Benadryl. The patient also experienced extreme fatigue, lymphadenopathy in armpit and injection site, headache, body aches, and nausea. Therapeutice measures were taken as a result of the events. Clinical outcome of the events was recovering.
35 2021-02-03 itchy skin facial swelling; itching; blurred eye sight as times; This is a spontaneous report from a contactabl... Read more
facial swelling; itching; blurred eye sight as times; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (lot number: EL0140), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. Medical history included allergies to shellfish from an unknown date. The patient's concomitant medications were not reported. The patient previously took topamax and experienced allergies. On 01Jan2021, the patient experienced facial swelling, itching and blurred eyesight as times. The patient was not pregnant. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 01Jan2021. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of facial swelling, itching and blurred eyesight as times which includes steroids and antihistamines. The outcome of the events was recovering.
35 2021-02-04 injection site pain, injection site pruritus, injection site reaction, injection site swelling, injection site warmth 4.5 inch in diameter, swollen and red area around injection site.. tender, very itchy, and warm to t... Read more
4.5 inch in diameter, swollen and red area around injection site.. tender, very itchy, and warm to the touch.
35 2021-02-04 redness, hives Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes ... Read more
Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes after shot, neck became red, red welts appeared on bilateral upper arms. took 25mg of po benadryl at my desk. 25 minutes after shot felt hot, dizzy, arms and legs tingling, breathless, limbs went numb, rushed to ER via wheelchair. Treated in er for anaphylaxis. Arms and legs felt covered in "icy hot," tachycardia for several hours, numerous times felt impending doom. hospitalized overnight on cardiac monitor. ER gave steroids, benadryl, pepcid, 2L ivf. ativan given later in evening for nervousness.
35 2021-02-04 itchy skin Facial swelling. Itching. Throat tightness. Chest tightness
35 2021-02-04 itchy skin, redness Large (5x4cm ovoid) area of erythema and pruritus just below injection site on LUE. Lasted about one... Read more
Large (5x4cm ovoid) area of erythema and pruritus just below injection site on LUE. Lasted about one week and self resolved
35 2021-02-04 vaccination site pain Very Fatigued; Fevers; Chills; Headache; Pressure in head; Muscle aches; soreness in whole body; Wea... Read more
Very Fatigued; Fevers; Chills; Headache; Pressure in head; Muscle aches; soreness in whole body; Weakness; Stomach ache with diarrhea; Stomach ache with diarrhea; Injection site pain; Armpit pain & swelling; Armpit pain & swelling; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3246) solution for injection intramuscular in the left arm on 18Jan2021 at 03:30 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included chronic spontaneous urticaria. Concomitant medications included omalizumab (XOLAIR), lisdexamfetamine mesylate (VYVANSE), famotidine (PEPCID AC), fexofenadine hydrochloride (ALLEGRA), valacyclovir, fish oil, probiotic, medical marijuana. The patient had no known allergies. Historical vaccine included BNT162B2 (Pfizer, Lot EJ1685) in Dec2020 at 06:15 intramuscular in left arm for COVID-19 vaccination for 1st dose with no adverse event. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021 at 11:00, the patient experienced very fatigued, fevers, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. No treatment was provided for the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. The outcome of the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
35 2021-02-04 rash, itchy skin chest tightness, rash on neck/chest with itchiness
35 2021-02-04 injection site pain, injection site bruising injection site pain, tiredness, headache, muscle pain chills, joint pain, feeling unwell, bruising a... Read more
injection site pain, tiredness, headache, muscle pain chills, joint pain, feeling unwell, bruising at the site of injection
35 2021-02-04 vaccination site warmth, vaccination site swelling right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It a... Read more
right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It appears to be getting bigger everyday.; right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It appears to be getting bigger everyday.; right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It appears to be getting bigger everyday.; This is a spontaneous report from a contactable Nurse. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL0142, intramuscular on 18Jan2021 14:45 at SINGLE DOSE second dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The first dose of vaccine bnt162b2 was administered on 28Dec2020 lot number=EJ1685 vaccine location left arm. The patient reported that "right deltoid where the injection site has a local redness, it is warm touch and appears swollen and is getting bigger everyday" on 18Jan2021 16:00 with outcome of not recovered. The action taken was not applicable.
35 2021-02-05 itchy skin Patient experienced itchy palm and lightheadedness. She was treated with 25mg of Benedryl and observ... Read more
Patient experienced itchy palm and lightheadedness. She was treated with 25mg of Benedryl and observed for 30 minutes during which time symptoms resolved.
35 2021-02-07 injection site reaction, skin tightness, injection site numbness, injection site swelling 1258 C/O LEFT SIDE SURFACE NUMBNESS BELOW INJECTION SITE , UNABLE TO FEEL LIGHT TOUCH VSS 133/89; SA... Read more
1258 C/O LEFT SIDE SURFACE NUMBNESS BELOW INJECTION SITE , UNABLE TO FEEL LIGHT TOUCH VSS 133/89; SAT 98% HR 801310: C/O LEFT ARM HEAVINESS AND A "THICK" SENSATION; FROM DELTOID TO UPPER BICEPS1326: HEAVINESS AND TIGHTNESS DECREASING ;1338: HEAVINESS ALMOST RESOLVED.
35 2021-02-07 cellulitis After both injections I have experienced cellulitis in my eyes; first in my left eye developing less... Read more
After both injections I have experienced cellulitis in my eyes; first in my left eye developing less than 24 hours after the injection and then cellulitis in my right eye developing about 3 days after the 2nd injection
35 2021-02-07 rash, shingles Rash on upper left temple and swollen lymph nodes around left ear started on Friday. Headaches resem... Read more
Rash on upper left temple and swollen lymph nodes around left ear started on Friday. Headaches resembling a tension headache radiated up the left side of the face and skin is sensitive to the touch through the weekend. Diagnosed at shingles and antiviral medication prescribed on Monday. Visiting Opthalmologist as rash is near eye.
35 2021-02-07 itchy skin Started with itching and slight fever on Friday night, fever has been on and off for 3 days, itching... Read more
Started with itching and slight fever on Friday night, fever has been on and off for 3 days, itching continues, slight worsening in cough.
35 2021-02-08 injection site mass, itchy skin 20 minutes after receiving the vaccine I started to feel swelling in my throat and a hot, tingling f... Read more
20 minutes after receiving the vaccine I started to feel swelling in my throat and a hot, tingling feeling on the inside surfaces of my mouth and tongue, my arm was also very itchy and had a lump approximately the size of half a golf ball at the injection site. I developed a severe headache as well. 23 minutes after the vaccine, I took 25 mg of Benedryl PO, 38 minutes after the vaccine, I took an additional 25 mg of Benedryl PO and 10 mg Zyrtec PO because my symptoms had not yet resolved. Approximately 1.5 hours after the vaccine administration my symptoms resolved, except for the headache and the lump on my arm.
35 2021-02-08 redness, injection site pain, skin warm Approx. 5 hours after vaccine administered, bad headache and fatigue. Injection site and all upper a... Read more
Approx. 5 hours after vaccine administered, bad headache and fatigue. Injection site and all upper arm became very sore to the touch Approx. 6 hours after vaccine, face became very flushed, hot and inflamed. Lips began to slightly swell - both upper arms became red and hot, skin flushed - headache and fatigue persisted - fever of 99.9 Benadryl taken 8 hours after vaccine, which helped with hot feeling in face and hands, lip swelling went away
35 2021-02-09 vaccination site swelling, vaccination site pain after right above my clavicle on my right side was swollen and tender to touch. It took until day 8 ... Read more
after right above my clavicle on my right side was swollen and tender to touch. It took until day 8 or 9 to still be swollen and palpable but not tender.; about 9 hours after right above my clavicle on my right side was swollen and tender to touch. It took until day 8 or 9 to still be swollen and palpable but not tender.; This is a spontaneous report from a contactable Nurse reported for herself. A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Pfizer) second dose at right arm intramuscularly on 09Jan2021 07:30 AM at single dose for covid-19 immunisation. The historical vaccine include bnt162b2 on 19Dec2020 07:45 AM first dose at right arm intramuscularly at single dose for covid-19 immunisation in hospital. Medical history included ongoing covid-19. Prior to vaccination was the patient diagnosed with COVID-19. There was no allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included paracetamol (TYLENOL), ibuprofen, omeprazole (PRILOSEC) and gummy hair skin and nails vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second shot on 09Jan2021 about 9 hours (05:00 PM) after right above her clavicle on her right side was swollen and tender to touch. It took until day 8 or 9 to still be swollen and palpable but not tender. As of 30Jan2021, it's been 3 weeks and still there just as big but not tender. There was no seriousness criteria for the events results in death, life threatening, Disabling/Incapacitating and congenital anomaly/birth defect. Since the vaccination, has the patient not been tested for COVID-19. There was no events treatment for the events. The outcome of the events were not recovered. Information on the lot/batch number has been requested.
35 2021-02-09 vaccination site pain could not lift or move arm; Shoulder was hurting from the injection site; This is a spontaneous repo... Read more
could not lift or move arm; Shoulder was hurting from the injection site; This is a spontaneous report from a contactable consumer reported for herself. A 35-year-old female patient received first dose of bnt162b2 (report as PFIZER COVID-19 VACCINE, Lot number: E11284, Vaccine location: Left arm), via an unspecified route of administration on 08Jan2021 11:30 AM at single dose for COVID-19 immunization. The patient did not have allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included methylphenidate hydrochloride (CONCERTA) from an unspecified date to an unspecified date, influenza vaccine (FLU SHOT) on 18Dec2020 for immunization. The patient reported Friday evening (08Jan2021 06:00 PM) her shoulder was hurting from the injection site. When she woke up Saturday 09Jan2021, she could not lift or move her arm. This followed into Monday. It was now 25Jan2021 and she was still not able to life her arm all the way and she still had a constant pain in her shoulder. It was unknown if patient received treatment for the events. These events did not result in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, was not congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient did not have been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Facility. The outcome of the events was not resolved.
35 2021-02-11 itchy skin Itchy body
35 2021-02-11 hives Presented with lower lip swelling and hives to inside of cheek within a few minutes of receiving the... Read more
Presented with lower lip swelling and hives to inside of cheek within a few minutes of receiving the vaccine. No tongue swelling. No SOB or throat itchiness. Offered Benadryl and transport to ED but she declined and went home.
35 2021-02-14 injection site pain Day after: chills, fever not controlled by Tylenol and ibuprofen, body aches, lymph node area painfu... Read more
Day after: chills, fever not controlled by Tylenol and ibuprofen, body aches, lymph node area painful, painful at injection site, fatigue Ongoing (day 5 today): Severe pain in back and hips, shooting pain in lymph node areas, severe fatigue, low grade fever off and on
35 2021-02-14 injection site swelling, injection site pain Pain and swelling at the injection site
35 2021-02-15 hives, itchy skin Several minutes after receiving vaccine patient developed itching and hives and swelling. EMS and I... Read more
Several minutes after receiving vaccine patient developed itching and hives and swelling. EMS and I were on hand. Initially we were going to administer IV benadryl however the patient developed stated her throat was itchy and started clearing her throat. At that point it was decided to give Epi Pen. This provided relief to the patient. The patient was then transported to ER.
35 2021-02-15 injection site irritation Severe extremity pain down limb of injection site. Pain was not muscular, but ache and level of int... Read more
Severe extremity pain down limb of injection site. Pain was not muscular, but ache and level of intensity was most similar to my experiences with broken bones. Pain did not appear similar to neurological symptoms (no numbness or tingling). AE was noted after both vaccine doses, with an marked increase in severity after second dose. No symptoms immediately after dose or within same day (very minor irritation at injection site). Next day, severe pain developed down entire left arm. Pain started slowly, increased over ~2 hours, and lasted for ~24 hours. Pain was isolated down arm from shoulder to fingertips, with most of the pain felt slightly above and around the elbow, in wrist, and in fingers. During episode, the pain was so severe that the weight of any clothing was unbearable (pain was most similar to my past experiences with broken bones). Additionally, I was unable to rest my arm or hand on anything (the pressure from resting my arm on a pillow was too severe). Range of motion was limited, and I could not extend my fingers without pain.
35 2021-02-16 injection site pain, injection site bruising 6 days after arm was sore at injection site, felt as if I had an Internal bruise, lasted about one d... Read more
6 days after arm was sore at injection site, felt as if I had an Internal bruise, lasted about one day
35 2021-02-16 injection site pain Pfizer COVID-19 Vaccine When given vaccine, had initial burning in deltoid. Right after flushing a... Read more
Pfizer COVID-19 Vaccine When given vaccine, had initial burning in deltoid. Right after flushing and sweating palms, along with nausea. Lasted 5 minutes. Next day fatigue, nausea, and sweats/chills. 3rd day same. 1/27/21: Pt received 2nd dose of COVID vaccine with no issue.
35 2021-02-16 itchy skin, sensitive skin Top and right side of right breast began itching within 6 hours of the vaccine, with increased sens... Read more
Top and right side of right breast began itching within 6 hours of the vaccine, with increased sensitivity from nipple to ribs. The itching continues now, 6 days later, but 4 days after vaccine (2 days ago), the itching was compounded with pain (same area as itching) and lumps (some at the base of right breast, others even into right armpit). They are not visibly red nor are they warm to the touch, but I can feel them under the skin, unlike the same area on the left breast.
35 2021-02-17 rash Rash; blurred vision; loss of balance; headache; nausea; This is a spontaneous report from a contact... Read more
Rash; blurred vision; loss of balance; headache; nausea; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 27Jan2021 08:30 at single dose for Covid-19 immunization. The patient was not pregnant at time of vaccination. The Patient's medical history included Hbp (Blood pressure high). The Patient's concomitant medication included lisinopril, famotidine, and ferrous sulfate. The patient previously took Procardia and Amoxicillin; both experienced allergies. On 28Jan2021, the patient experienced rash, blurred vision, loss of balance, headache, and nausea. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not tested for covid since vaccination.
35 2021-02-17 rash, vaccination site swelling, vaccination site pain This is a spontaneous report from a contactable consumer (reporting for herself). A 35-year-old fema... Read more
This is a spontaneous report from a contactable consumer (reporting for herself). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (left arm) on 28Jan2021 18:30 (at the age of 35 years) at single dose for Covid-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam, and "omniprozol" (as reported); all taken from an unspecified date (reported as received within 2 weeks of vaccination) for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 18:30 (also reported as "24 hours after vaccine"), the patient experienced pain and swelling at injection site. The patient also experienced rash on leg and elbows starting day 3 (as reported) to present. There was no treatment received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. Information on the lot/batch number has been requested.
35 2021-02-21 injection site pain Fever, aches, headaches, fatigue, sore throat, arm pain at injection site, diarrhea, nausea Started... Read more
Fever, aches, headaches, fatigue, sore throat, arm pain at injection site, diarrhea, nausea Started same day and have lasted a week
35 2021-02-21 rash, itchy skin Rash and itchiness within 30 minute waiting period
35 2021-02-21 itchy skin ear pruritus in right ear, itchy skin just above affected ear on scalp, and skin behind affected ear... Read more
ear pruritus in right ear, itchy skin just above affected ear on scalp, and skin behind affected ear and just under ear on throat/neck. All related mild and just a little annoying but I was advised to report it all the same.
35 2021-02-21 hives large quarter sized hives all over; This is a spontaneous report from a contactable nurse (patient).... Read more
large quarter sized hives all over; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via unspecified route of administration on left arm on 05Feb2021 at 08:30 AM at single dose for COVID-19 immunization. The relevant medical history included known allergies: lyrica, possibly cilantro, pollens; insulin resistance; vitamin D def (Vitamin D deficiency); GERD (Gastrooesophageal reflux disease). Concomitant medications included metformin, famotidine (PEPCID), clarithromycin (CLARTIN), topirmate, diphenhydramine hydrochloride (BENEDRYL). The patient previously received first dose of BNT162B2 (lot number: EH9899) at the age of 35 years old, via unspecified route of administration on left arm on 11Jan2021 at 03:30 PM for COVID-19 immunization (first vaccine administered and was fine then had hives and swollen eye on the day the second was to be administered. Delayed shot- received solumedrol shot and prednisone oral with benedryl/pepcid/atarax). The patient took second shot 1 week later on Friday with prednisone on board - woke up on Sunday AM with large quarter sized hives all over. The event resulted in emergency room/department or urgent care. The event was reported serious due to hospitalization. Treatment received included urgent care- Solumedrol shot- RXs. No other vaccine in four weeks. The outcome of the event was recovering.; Sender's Comments: Based on available information and plausible temporal association, a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported event large quarter sized hives all over. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-02-22 injection site hives, injection site swelling, injection site pain, injection site pruritus Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also mor... Read more
Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also more tired than usual. Later that evening my injection site was sore, itchy, and raised, like a hive. On 2/23/21 I woke up at about 7:30AM and the injection site was the same as before, but I also had a sore/stiff neck and headache at the base of my skull. The reactions have not warranted a trip to the doctor, but I remember hearing somewhere that the CDC was interested to know about any side effects that may be related to the vaccine.
35 2021-02-22 hives Hives, Angioedema, slight cough and wheezing
35 2021-02-23 vaccination site pain maybe a little low iron but not too remarkable; swelling in middle finger of right hand/puffiness in... Read more
maybe a little low iron but not too remarkable; swelling in middle finger of right hand/puffiness in all of fingers and toes and around eyes; puffiness in all of fingers and toes and around eyes; she was not feeling great; fatigue; headache; soreness in her arm at the injection site; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her right arm, via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 23Dec2020, she was not feeling great, had fatigue and headache. On 25Dec2020, she had swelling in her right middle finger, states that has now progressed to swelling in all her fingers, toes and around her eyes. Also reported that on 21Dec2020, she had soreness in her arm at the injection site that went away the same day. The patient also mentioned that she tested negative for Covid. The patient is also a little low iron but not too remarkable. The outcome of the event vaccination site pain was recovered in 21Dec2020, not recovered for peripheral swelling and puffy eyes while unknown for the other events. Information on Lot/Batch has been requested.
35 2021-02-24 itchy rash, rash, pain of skin, skin burning sensation, blister, redness 3 days after the first dose was received, rashes developed under my chin and necks area with itching... Read more
3 days after the first dose was received, rashes developed under my chin and necks area with itching, and stinging sensation. The symptoms went away a couple days later. The same symptoms would appear a couple more times spacing out about 2- 3 weeks after the initial reaction. Then on 2/17/2021, the same symptoms appear again but this time it would spread out to my entire neck and also my face. Symptoms included facial swelling, redness, blisters, along with stinging, burning, and itching sensation. I did not crossed my mind that it was a reaction, but come to think of it, all of these happened after the vaccinations. I did seek medical treatment on 2/18/21 and was treated with steroid pack. Although the medication treatment regime had completed, I still have symptoms of itchiness under my chin and neck as well as the rashes are still visible.
35 2021-02-24 redness Joint pain, swelling, and redness of right middle knuckle starting three to four days post vaccinati... Read more
Joint pain, swelling, and redness of right middle knuckle starting three to four days post vaccination. Unable to grasp and tighten fist with grip weakness. Only on that hand and that specific knuckle. Treated with Tylenol 1000 mg, ibuprofen 400 to 600 mg, and benadryl 25 mg, and zyrtec 10 mg for 3 to 4 days after symptom onset. Returned to normal function in about 10 days. After second dose of Pfizer symptoms did not really develop immediately but noticed 3 weeks after symptoms returned. The symptoms seem to come and go and do not know if they have fully resolved yet.
35 2021-02-24 shingles Shingles
35 2021-02-24 injection site pain When given vaccine, had initial burning in deltoid. Right after flushing and sweating palms, along w... Read more
When given vaccine, had initial burning in deltoid. Right after flushing and sweating palms, along with nausea. Lasted 5 minutes. Next day fatigue, nausea, and sweats/chills. 3rd day same. 1/27/21: Pt received 2nd dose of COVID vaccine with no issue.
35 2021-02-25 injection site pain Injection site pain, stiffness, weakness in the right shoulder from 8 pm until 8 am following day. ... Read more
Injection site pain, stiffness, weakness in the right shoulder from 8 pm until 8 am following day. On 2/20/21 (2 days later), had sudden episode of body aching, weakness, tachycardia, extreme fatigue, nausea that lasts 1-2 hours . on 2/22/21 again had episode suddenly of shaking, aching, nausea, stomach pain, fatigue, chills, no fever, clammy skin that lasted 1-2 hours
35 2021-02-25 itchy skin Itching, SOB, cough, evaluated by EMS-cleared
35 2021-02-25 shingles Started with pain in left breast a couple days after vaccine given, then developed the Shingles rash... Read more
Started with pain in left breast a couple days after vaccine given, then developed the Shingles rash a week after vaccine was given.
35 2021-02-25 skin discolouration, itchy skin Within minutes after the vaccine I felt hot, removed my jacked but then I got chilled, my right hand... Read more
Within minutes after the vaccine I felt hot, removed my jacked but then I got chilled, my right hand begin itching which moved to the left hand. I was taken to the ER and was administed benedryl. I was transported to the hospital via ambulance because my mouth and throat was extremely dry and my voice got hardened. During the ride I regurgiatated because my stomach got queezy and was administered Zofran. My right hand turned completely white and I was administered another med to help turn my hand back right. My baby was checked and she was fine and was released after about 3 hrs. At that time I was 31 week gestation. Until about 3 days ago my body was still very very itchy all over which seemed to worsen when I was sleep.
35 2021-02-27 injection site pain Headache, chills, low grade fever, muscle aches, injection site pain, lymph node pain
35 2021-02-28 hives, itchy skin I got a really sweet 8 inch diameter hive on the injected arm. It is hot and very itchy. It's not wh... Read more
I got a really sweet 8 inch diameter hive on the injected arm. It is hot and very itchy. It's not where the injection was actually at, which is weird.
35 2021-02-28 shingles Shingles outbreak on scalp, ears and face. Taking valtrex, neurontin, and prednisone. Also may have... Read more
Shingles outbreak on scalp, ears and face. Taking valtrex, neurontin, and prednisone. Also may have some loss of vision in right eye and instructed to use prescription eye drops 4 times a day for 3 weeks.
35 2021-03-01 shingles On 2/26/21 my left eye started to itch, burn, and the eye felt drier than normal. On 2/27/21 there w... Read more
On 2/26/21 my left eye started to itch, burn, and the eye felt drier than normal. On 2/27/21 there was a noticeable red patch on the eyelid with small scaly looking spots, I assumed it to be a patch of dry skin. There was a 30 minute period of intense tingling pain and shooting/stabbing intermittent pain. There was also some numbness later on that day. Also on 2/27/21 I noticed a large lymphnode swelling on my jawline adjacent to my left ear. On 3/1/21 I saw my primary care provider and was diagnosed with shingles. After reviewing the preliminary symptoms of shingles, I had been experiencing abnormal fatigue and stomach upset for about 5 days prior to the eruption.
35 2021-03-01 hives, itchy skin Reported information from patient: I had a severe reaction to the COVID-19 vaccine. Met with Dr. an... Read more
Reported information from patient: I had a severe reaction to the COVID-19 vaccine. Met with Dr. and did a series of skin testing for PEG allergy. All were negative and progressed to a microdose of the vaccine. Continued to have no reaction so remaining dose was administered. I waited 2 hours in clinic and experienced some mild pruritic symptoms. Took 2 zytrtec and went home. the next day experienced some throat swelling with shortness of breath. Took additional allergy medication and contacted Dr. He prescribed prednisone and up to 4 allergy tabs a day. I developed increased shortness of breath, hives on my tongue which developed into ulcerations. The waves of throat swelling would come every 4 hours or so. Was able to manage with oral agents, did not administer the prescribed epi-pen. These symptoms started on that Tuesday and were severe enough to keep me home from work until Feb 15th (I work Monday/Wednesday). Throat swelling and coughing persists but it markedly improved. Now understand I have a non-IGE mediated allergy to PEG. Patient wanted to receive the COVID vaccine so was seen by an allergist given previous history of possible polyethylene glycol allergy. Following review and discussion of risks patient was scheduled to receive a test dose. Provider notes as follows: She has had several occasions where she has developed shortness of breath and "generally not feeling well," within 1 to 2 hours of taking MiraLAX. She has not had any reactions to any prior injectable medications or vaccinations. Due to this MiraLAX potential allergy there is a contraindication to receiving the Pfizer or my during a Covid vaccine. What I have recommended since she would like to be vaccinated is to have her to return to clinic at which time we will do skin testing with skin prick and intradermal to polyethylene glycol as well as polysorbate 20 and polysorbate 80. If the allergy testing to polyethylene clean glycol is negative we will then give her graded dosing of the COVID-19 vaccine and monitor her in clinic. If the polyethylene glycol is positive but the polysorbate testing are negative she may be a candidate for receiving one of the newer vaccines which are yet to be on the market. The patient was seen today for a new problem which is polyethylene glycol allergy and the need for COVID-19 vaccination. She will return for testing to the vaccine components and then intramuscular graded challenge if necessary. Prior to the graded challenge skin prick testing to MiraLAX was completed which was negative. Skin prick testing and intradermal testing was also completed for Solu-Medrol, Depo-Medrol and triamcinolone. The Depo-Medrol contains polyethylene glycol, the triamcinolone contains polysorbate 80 and the Solu-Medrol functions as a control without any polyethylene glycol or polysorbate. All skin prick and intradermal testing was negative. An ~10% dose of the COVID-19 vaccine was given and the patient was monitored for 30 minutes. The remaining ~90% of the COVID-19 vaccine was then given and the patient was monitored for an additional 90 minutes. The patient received pre-medications with: Zyrtec and Tylenol
35 2021-03-01 injection site mass, itchy skin developed a firm tender lump at injection site. The area is improving- mild itching and soreness. No... Read more
developed a firm tender lump at injection site. The area is improving- mild itching and soreness. No fever, chills, fatigue or malaise
35 2021-03-02 itchy skin Generalized itching; BP 103/66 (pulse 67).
35 2021-03-02 hives Hives all over my body; Severe abdominal pain; This is a spontaneous report from a contactable other... Read more
Hives all over my body; Severe abdominal pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot/batch number and expiry date unknown), intramuscular on 06Jan2021 13:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced hives all over her body and severe abdominal pain on 07Jan2021. The patient received treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The outcome of the events were recovered on an unspecified date. The events were reported as non-serious. No seriousness criteria provided. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Information on the lot/batch number has been requested.
35 2021-03-02 vaccination site pain Injection site pain; This is a spontaneous report from a contactable nurse (patient). A 35-year-old ... Read more
Injection site pain; This is a spontaneous report from a contactable nurse (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (brand=Pfizer), lot no. EK5730, intramuscular (right arm) on 07Jan2021 11:30 at a single dose for COVID-19 immunization at a hospital. The patient had no relevant medical history. She had no known allergies. Concomitant medication included colecalciferol (VITA D). No other vaccine in four weeks. No COVID prior vaccination. The patient experienced injection site pain on 07Jan2021 12:00 PM. No treatment received. No COVID test post vaccination. The patient recovered from injection site pain on an unspecified date.
35 2021-03-02 rash The morning after the vaccine, I woke up with a generalized rash across my abdomen, evenly dispersed... Read more
The morning after the vaccine, I woke up with a generalized rash across my abdomen, evenly dispersed across my torso. Nonpruritic.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL9261), intramuscular in the left arm on 25Jan2021 14:00 (at the age of 35-years-old) at single dose for COVID-19 immunization in a hospital. The patient had no medical history. The patient was not pregnant. The patient had no known allergies. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) and birth control pills. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination. On 26Jan2021 at 06:00 AM, the morning after the vaccine, the patient woke up with a generalized rash across her abdomen, evenly dispersed across her torso. It was nonpruritic. The patient received BENADRYL and CLARITIN as treatment for the event. The patient was not tested for COVID post vaccination. The outcome of the event was recovering.
35 2021-03-03 injection site redness, injection site hardening, injection site pain, injection site swelling Pain, swelling, hardness and red lesion at injection site. Also very itchy. Symptoms of "COVID Arm."
35 2021-03-03 itchy skin, hives, rash with redness, rash The following day, she complained of headache, fatigue, dizziness, and lightheadedness for 3 days. O... Read more
The following day, she complained of headache, fatigue, dizziness, and lightheadedness for 3 days. On 2/19/2021 she experienced hives on her abdomen and back that were itchy. No medicine was taken. On the 2/20/2021, she complained of further headache, fatigue, dizziness. She also had shortness of breath. The next day, she presented to the urgent care. She was given an intravenous fluid bolus for dehydration. She was given a "migraine cocktail." She was told that her D-dimer was positive. She had a CT scan that showed sinusitis and her chest was clear. The following day, she complained of progressively worsened ascending pain in her left arm. She had red patches of a rash in her left arm as well. One week later, she went back to the urgent care. An ultrasound was performed and a blood clot was found at. She is now taking Eliquis daily.
35 2021-03-04 redness At Approximately 1040, patient (Age 35,) received her 2nd dose of Pfizer vaccine (Lot# 6200 Exp. 06/... Read more
At Approximately 1040, patient (Age 35,) received her 2nd dose of Pfizer vaccine (Lot# 6200 Exp. 06/2021). At approximately 1055, EMT was alerted by patient that she felt her tongue somewhat swollen and itchiness in the back of tongue, patient was sitting in observation chair at this time, A&Ox4. At approximately 1100, pt was moved to zero gravity chair, water was given, pt remained A&Ox4 and pink in color. Pt reported allergy to Penicillin- reaction Hives and also has seasonal allergies, with no past history of anaphylaxis. At approximately 1112, RN Lead spoke with patient and EMT about how patient is feeling, patient declined to have EMS called, patient was offered Benadryl, patient agreed and took Benadryl 25mg in 10ml Oral Solution. Vital signs at 1117: HR 74, RR 14, BP 130/90, Vital Signs at 1123 HR 70, RR 14, BP 128/90. At 1125, Patient claims symptoms not worsening. At 1128, tongue did not swell up more than initial complaint. At 1128, Pt stated she ?felt better? and left the facility, Pt A&Ox4, pink in color, ambulating with steady gait, driving herself in her vehicle. Pt verbalized understanding to call her doctor or 911 if she felt anything worsening.
35 2021-03-04 dry skin Extremely dry scalp (spot at top right side of head and behind left ear)
35 2021-03-04 vaccination site warmth, bruising, vaccination site itchiness, vaccination site redness Pale; Sweaty; her left arm was extremely sore; elevated heart rate/heart rate was in the 120s, and s... Read more
Pale; Sweaty; her left arm was extremely sore; elevated heart rate/heart rate was in the 120s, and she usually has a heart rate in the 80s; shortness of breath; approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; Blood pressure increased; Clammy/cold sweat; muscle tenderness/all the muscles in her left arm were tender/aching; bruising near the injection site; she had bruising (more than usual) throughout the rest of her body; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; anxiety; This is a spontaneous report from a contactable consumer (patient/Registered Medical Assistant). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0142), via an unspecified route of administration on 12Jan2021 14:30 (2:30 PM) at single dose on left deltoid for COVID-19 immunization. Vaccination facility type is hospital. No history of previous immunization and no additional vaccines administered on same date of Pfizer suspect, also reported as "Prior Vaccinations (within 4 weeks): None". Medical history included ongoing Vitamin D deficiency for quite a few years. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) from Oct2020 and ongoing at 50000 IU gel cap, once weekly for Vitamin D deficiency. Patient is scheduled to receive the second dose of Pfizer vaccine on 02Feb2021 but reported side effects from her first shot including bruising near the injection site, shortness of breath, muscle tenderness and elevated heart rate (main concern). Upon contacting her HCP, she mentioned that this may be a side effect of her anxiety medications and asked "Should she take the second dose?". Approximately 22hours (13Jan2021) after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site. COVID-19 vaccine injection site became red, warm, and itchy, also experienced blood pressure increased, shortness of breath and Clammy, all on 13Jan2021. The patient was pale on 13Dec2020. Patient noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) that the lymph nodes in her left axillary (or armpit area) were swollen, and super tender (onset reported as "Jan2021"). Patient became sweaty on 14Jan2021. It was further reported that patient received her first COVID-19 Vaccine dose on 12Jan2021 2:30PM . She said after receiving the first COVID-19 Vaccine, she has had multiple symptoms. Patient is now due for her second COVID-19 Vaccine dose today 02Feb2021. Patient did not know if she should get the second COVID-19 Vaccine dose, and if her side effects were from the first COVID-19 Vaccine. Patient works in a doctor's office where there is a medical doctor, nurse practitioner, and several other registered medical assistants. Approximately 12 hours later after vaccine, at 2:30AM (13Jan2021), her left arm was extremely sore. She said she went to work on Wednesday, 13Jan2021, and her left arm was still really sore, but she was fine, otherwise. She said approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID- 19 Vaccine injection site. She said her COVID-19 Vaccine was given a lot higher than she thinks the vaccine should have been given. She said the COVID-19 Vaccine injection site became red, warm, and itchy. Her heart rate and blood pressure shot up, and she had pretty bad shortness of breath. Patient said that the medical doctor and nurse practitioner (where she works) told her she gave herself a panic attack. She said that the medical doctor, who she works for, told her to go home, and to contact her primary care doctor if she doesn't feel better. Patient left work and went home. Patient clarified her heart rate was in the 120s, and she usually has a heart rate in the 80s. She said she was pale and clammy, too. Patient stated that she went to bed when she got home from work on 13Jan2021, and woke up the next morning (Thursday, 14Jan2021), and got ready for work. She said as she was getting dressed for work, she felt her pulse rate go up, and she became sweaty, and clammy. She said she called her work, and her boss (medical doctor) told her to take some Tylenol and rest, and to call her primary care doctor if she was not feeling better. Patient said that her primary care doctor said she was having anxiety, and started her on medicine. She said the medicine helped, but her heart rate was still 112-115. She said she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender. She said all the muscles in her left arm were tender, as well. She said her left arm muscles were still aching. She said she had bruising on her left arm, and noticed she had bruising (more than usual) throughout the rest of her body. She said she has no idea if the bruising is a coincidence, or if the bruising is related to receiving the COVID-19 Vaccine. Patient mentioned that her left axillary lymph nodes were swollen for a good week and a half, but the swelling improved and was gone now. She said her heart rate was still elevated at 106-110 when she last checked her heart rate an hour and half ago. She said her heart rate was elevated, even though she was sitting down doing tele-work, and she has been taking anxiety medicine. She said she was still having breathing discomfort, clarifying she could not take a big enough breath. Patient will take a big breath, and will be good for a while, but then she needs to take another big breath. She said her doctor has checked her lungs, and her lungs were clear. She said she has to take multiple, deep breaths throughout the day. Patient's last blood work was in Oct2020. She said everything was good with her blood work. She said her hormones were good, but she had a Vitamin D deficiency. For treatment, patient stated that her primary care doctor prescribed Buspar 7.5mg, twice a day. She said the Buspar 7.5mg was dispensed in a pharmacy bottle and did not have the NCD, Lot, and Expiration Date. She said it will be 3 weeks from tomorrow (03Feb2021) she has been taking the Buspar 7.5mg and reported everyone seems to think she has anxiety, or she was crazy. Events did not require emergency room visit but patient visited physician office. There were no relevant tests. Outcome of muscles in her left arm were tender/aching, was not recovered, for axillary lymph nodes swelling and tender was recovered in 2021, for heart rate was elevated, Shortness of breath/breathing discomfort was recovering while for other events was unknown.
35 2021-03-06 hives Hives. Benadryl po x 3 days now
35 2021-03-06 hives, itchy skin hives, significant itching, body aches, pain in arm
35 2021-03-08 injection site pruritus, injection site redness, injection site rash ?COVID Arm?: Itching at vaccination site followed by red rash. Symptoms began on evening of the 9th ... Read more
?COVID Arm?: Itching at vaccination site followed by red rash. Symptoms began on evening of the 9th day following first dose of Pfizer vaccine. This report is being submitted on the 10th day following vaccine as symptoms have continued.
35 2021-03-08 rash with redness, hives, skin warm, skin irritation, itchy rash, rash papular, rash macular, rash Beginning the day after my injection (2/27), I experienced soreness in my left shoulder above inject... Read more
Beginning the day after my injection (2/27), I experienced soreness in my left shoulder above injection site. The following day, the soreness migrated to my neck on the left side. It felt like a kink in my neck. As the day went on, the stiffness spread through my entire neck and back. Tylenol and ibuprofen did not help to reduce any pain I was feeling. This stiffness and pain lasted 9 days. On the 10th day after my injection (3/8/21), I experienced a sudden full-body welting rash that spread very quickly. I tool zyrtec and allegra to try to stop it, but the rash is still present today (3/9/21). I had a rapid test done today for confirmation that it was not a sign of the actual covid-19 virus because it looks like several reported images, but the test came back negative. Initially, the rash was very uncomfortable. It felt like a stinging itch, and my skin was hot to the touch. It was red, splotchy, raised, and felt like a sun burn. Today, the rash is still visible, not as raised or red, but can still be felt and is a lighter shade of red. My skin is not as hot to the touch, but still warmer over the raised parts of the rash. It does not hurt, but if loose clothing rubs on it, or I accidentally scratch it, it does start to itch and get irritated. I do have pictures of the different stages in progression if needed.
35 2021-03-09 shingles Shingles
35 2021-03-09 hives swollen eye; hives; This is a spontaneous report from a contactable Nurse, the patient. A 35-year-ol... Read more
swollen eye; hives; This is a spontaneous report from a contactable Nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 11Jan2021 at 15:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included insulin resistance, vitamin D deficiency, GERD (Gastrooesophageal reflux disease) and allergy to pollen and possible allergy to cilantro. Prior to the vaccination, it was unknown if the patient was not diagnosed with COVID-19. Concomitant medications included metformin, famotidine (PEPCID [FAMOTIDINE]), clarithromycin (CLARITIN [CLARITHROMYCIN]), topirmate, and diphenhydramine hydrochloride (BENADRYL); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took pregabalin (LYRICA) from an unknown date for an unknown indication and experienced allergy. On 01Feb2021 at 06:00, the patient experienced hives and swollen eye. The patient reported that the first vaccine was administered and the patient was fine then the patient had hives and swollen eye on the day the second dose was to be administered. The second dose of the vaccine was delayed. The events resulted in an emergency room/urgent care visit and the patient received treatment for the events with solumedrol shot and prednisone oral with benadryl/pepcid/atarax. The patient received the second dose one week later, on Friday 05Feb2021, with prednisone on board. The clinical outcomes of the hives and swollen eye were recovering. It was also reported that since the vaccination, it was unknown if the patient had been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Hives cannot be totally excluded. The case will be reassessed if additional information becomes available.
35 2021-03-10 rash papular, itchy skin, rash, skin swelling, hives Hives Rash all over body Itch all over body bumps raised skin swelling
35 2021-03-11 hives after 30 minute wait Pt left clinic only to return with SOB, hives, stridor and itchy throat. Dry co... Read more
after 30 minute wait Pt left clinic only to return with SOB, hives, stridor and itchy throat. Dry cough Given epi 0.3 mg with resolution transferred to ED via EMS
35 2021-03-12 injection site pain Fever, very sore joints, aches and pain, fatigue, extremely sore arm at injection site
35 2021-03-12 itchy skin I was fine until exactly a week later. I started having itchiness and swelling in my ears, face and... Read more
I was fine until exactly a week later. I started having itchiness and swelling in my ears, face and throat. I took Albuterol and Benadryl at home. Then I went to the ER and they have me a steroid and Pepcid. I went home, and I was still very itchy. Then I went to urgent care and they repeated the treatment and I was fine by the 3rd day. I went to see my allergist and he wasn't sure if it was due to the vaccine. I was instructed to take the 2nd dose, but to take meds first. I took antihistamines before 2nd dose and I was fine.
35 2021-03-13 injection site pain, injection site redness, injection site swelling Headache, dizziness, lightheadedness. Diarrhea, stomach pain. Pain, swelling, and redness at injecti... Read more
Headache, dizziness, lightheadedness. Diarrhea, stomach pain. Pain, swelling, and redness at injection site
35 2021-03-14 itchy skin, rash Abdominal and back rash - have tried creams to resolve itching and appearance. Still some on my back... Read more
Abdominal and back rash - have tried creams to resolve itching and appearance. Still some on my back. Abdomen rash has cleared. Chest pain, right sided. Pain through jaw and shoulder. Felt as if I pulled a muscle. Slept a few hours and it was gone; had it not been gone when I woke up, I would?ve went to the ER.
35 2021-03-14 injection site tingling Arm which the shot was given, patient felt a tingle within seconds after receiving shot. Patient sai... Read more
Arm which the shot was given, patient felt a tingle within seconds after receiving shot. Patient said her arm started swelling minutes after the shot. No other side effects were experience. Patient did not have any pain, redness, warmth in the arm. Patient was given 25mg of liquid benadryl. She was monitored for almost 30 minutes after given benadryl. Patient said the tingling went away and the swelling was getting better.
35 2021-03-14 injection site pain Around 1030 PM on 3/12/2021 I woke up dry heaving. I then spent the night alternating between a cold... Read more
Around 1030 PM on 3/12/2021 I woke up dry heaving. I then spent the night alternating between a cold sweat and a hot sweat. When I woke up on the morning of 3/13/2021 my whole body hurt. I felt as if I had been run over by a truck. My left arm was very sore from the injection. My left underarm hurt. Across my upper back was sore and tender. My chest felt tight. I was nauseous all day. I took benedryl and Advil and slept most of the day. By 5:00 PM on 3/13/2021 I was feeling better but still hurting. By 3/14/2021 the pain had mostly gone away, but my left underarm is still sore and I am still very tired
35 2021-03-14 injection site hardening, injection site warmth, injection site swelling, injection site pruritus, injection site pain, injection site redness Body aches and fever and fatigue one day post vax. 2-5 days post vax injection site became red, swo... Read more
Body aches and fever and fatigue one day post vax. 2-5 days post vax injection site became red, swollen, painful, itching, hard and hot to the touch. On 3/13 spoke with a teladoc and stated it was infected and prescribed antibiotics stated if it wasn't better by the evening I needed to be seen at an urgent care or ER. 3/13 6:00pm - injection site was worse. Went to urgent care was prescribed steroid shot, oral steroids, topical cream and ibuprofen. Provider stated it may be an allergic reaction to something in the COVID vax
35 2021-03-14 injection site pain, injection site swelling Headache, vomiting, fatigue, injection site pain and swelling, cold symptoms
35 2021-03-14 injection site pain Pain at injection site as well as GI Issues such as intense cramping and diarrhea.
35 2021-03-14 hives Swollen, Tender Armpit lymph node on the same arm as injection site; Hives; This is a spontaneous re... Read more
Swollen, Tender Armpit lymph node on the same arm as injection site; Hives; This is a spontaneous report from a contactable other hcp (patient). This 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL1283), intramuscular at single dose in the left arm on 20Jan2021 09:45 for COVID-19 immunisation. Medical history included Penicillin allergy. Concomitant medications were not reported. On 01Feb2021, the patient experienced swollen, tender armpit lymph node on the same arm as injection site with outcome of not recovered (as reported), hives with outcome of not recovered (as reported). Treatment was required and included Benadryl and Cortisone cream for hives. The events were described as follows: "Swollen, tender armpit lymph node on the same arm as injection site, noticed a week after injection and resolved 10 days post injection. Hives reaction approx 2 weeks post injection, has continued 3 days". The events required a visit to the physician's office. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.
35 2021-03-15 itchy skin, hives At 3:47 pm (36 minutes after receiving shot) tongue swelled lips tingled, increased heart rate, and ... Read more
At 3:47 pm (36 minutes after receiving shot) tongue swelled lips tingled, increased heart rate, and extremities shook. Called 911 at 3:50 pm. Fire department came and blood pressure was high, heart rate was high, blood sugar was low. Fire fighter noticed hives on right shoulder (shot was administered in left arm) and they could see hives spreading across chest and neck. Hives covered upper torso but did not spread to abdomen or legs. Tongue swelled more making speech difficult. Breathing was easy, no constriction or wheezing heard through stethoscope. Vitals taken 2 or 3 more times, becoming more regular each time. Fire fighters provided Gatorade and discussed options. Fire department left at 4:10. I took Benadryl and Pepcid at 4:15. Tongue swelling decreased around 6 pm, but remained slightly swollen until 3/14/21. Hives visible and itchy until 3/15/21. Other symptoms included fatigue, dizziness, body aches. Triamcinolone was used topically on hives twice daily on 3/13/21 and 3/14/21.
35 2021-03-15 rash Rash began in left wrist. Now has started on neck and other wrist.
35 2021-03-15 injection site pain Shot received @ 9:45 am, normal arm tenderness started around 8 pm and continued through to the next... Read more
Shot received @ 9:45 am, normal arm tenderness started around 8 pm and continued through to the next day. The next day around 3 pm I started having pain in my left arm pit and the underneath of my arm in the injection area, by 9pm that night (day after receiving shot) the pain in my arm pit was so bad it hurt to lift my arm or lay one it. the following day Friday the 12th the pain continued in my left armpit and underneath of my arm. It was extremely painful to touch. My Saturday March 13th the pain had started to shift to the lower part of my arm pit and into the side of my left breast. On Sunday the 14th the pain in my breast was gone and I finally felt like I could lift my arm and sleep on it, It was just tender to the touch. Now it is tender to touch in the center of my armpit and the underneath of my arm from arm pit to elbow.
35 2021-03-15 bruising Sore big toes on both feet; bruising under toenails; poor circulation on both big toes; This is a sp... Read more
Sore big toes on both feet; bruising under toenails; poor circulation on both big toes; This is a spontaneous report from a contactable Other Health Professional. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 03Jan2021 at 09:30am (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. The patient had none medical history. The patients Concomitant medication included buprenorphine hydrochloride (SUBUTEX) taken for an unspecified indication, start and stop date were not reported. The patients past drug included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 administered in Arm Left arm on 23Dec2020 at 09:30am(Batch/Lot Number: EK5730) as single dose for covid-19 immunisation. The patient experienced sore big toes on both feet, bruising under toenails and poor circulation on both big toes on 15Jan2021 at 20:00. The outcome of the events was not recovered.
35 2021-03-16 itchy skin Vaccine given 3/17 @ 1150am. Started itching on hands and feeling SOB and CP 3/17 @ 1220. Brought t... Read more
Vaccine given 3/17 @ 1150am. Started itching on hands and feeling SOB and CP 3/17 @ 1220. Brought to ER by EMS 3/17 @ 1255. ER did not note a rash but patient was scratching when arrived and examed no angioedema/wheezing/or strider. Was given po diphenhydramine 25mg x 1 and famotidine 20mg po x 1. Sx resolved.
35 2021-03-17 itchy skin 3/18/21-0750 AM received vaccine, patient then experienced extreme itching throughout body and fatig... Read more
3/18/21-0750 AM received vaccine, patient then experienced extreme itching throughout body and fatigue. Patient states that she was having itching to throat and sneezing. Pt. took claritin around 10 am. Then around 1045 patient states that she started having headache and feels like she is coming down with a cold as well. Patient states that she is still itching from scalp all the way down to her knees. Pt. states that itching is tolerable. Denies hives, denies trouble breathing, denies shortness of breath.
35 2021-03-17 rash, itchy skin Employee received 2nd dose of Pfizer COVID19 vaccine at 1:00 pm on 3/17/2021 and 10 minutes after r... Read more
Employee received 2nd dose of Pfizer COVID19 vaccine at 1:00 pm on 3/17/2021 and 10 minutes after receiving the vaccine she developed skin rashes to her right forearm, left lower neck and left hand. She complained of itching to her left hand. She was escorted to the ER where she received treatment.
35 2021-03-17 injection site redness, injection site swelling Swelling and redness at injection site, such as in an allergic reaction, 3-4 in diameter.
35 2021-03-17 itchy skin itching in whole body specially in nose
35 2021-03-18 rash, itchy skin, blister, shingles, itchy rash A few hours after the vaccine on 3/17 , developed itching right lower abdomen/side. Within 5 hours ... Read more
A few hours after the vaccine on 3/17 , developed itching right lower abdomen/side. Within 5 hours of receiving vaccine, developed a rash that itches and hurts. On 3/19 came back to the clinic for evaluation, diagnosed with shingles. Has a cluster of erythematous vesicles on an erythematous base. Started on Valacyclovir 1gm every 8 hours x 7 days.
35 2021-03-18 hives Allergic response to Pfizer Covid Vaccine #1, resulting in immediate numbness and tingling in face a... Read more
Allergic response to Pfizer Covid Vaccine #1, resulting in immediate numbness and tingling in face and mouth, dry cough and tightness in throat. Hives present after 6 hours. Symptoms were controllable with benadryl for the first 6 hours, but became uncontrollable 6 hours after the vaccine. Patient went to Emergency Room to control symptoms.
35 2021-03-18 injection site pain Muscle pain along hip and back, injection site pain Fever spiked to 100.5 (current) about 39 hours ... Read more
Muscle pain along hip and back, injection site pain Fever spiked to 100.5 (current) about 39 hours after vaccine received.
35 2021-03-18 itchy skin Within about two minutes my head started feeling "off", my mouth started to go numb, my heart starte... Read more
Within about two minutes my head started feeling "off", my mouth started to go numb, my heart started to race, my face started itching/sweating and I could feel a headache coming on. I had a headache, chills, fatigue, increased body temperature (2+ degrees) and a sore arm for the rest of the day. I woke up this morning with a really sore arm. I could only lift my arm halfway up, due to the deep muscle pain.
35 2021-03-18 itchy skin itching all over. Evaluated by EMS-Cleared
35 2021-03-19 injection site pain Nausea/upset stomach Sore arm at site of injection
35 2021-03-19 hives Patient received ?rst in series covid vaccine at approximately 915... she breastfed her 12 month-old... Read more
Patient received ?rst in series covid vaccine at approximately 915... she breastfed her 12 month-old infant shortly thereafter without problem. around 1215 baby was getting fussy and breastfed for about 5 minutes before baby broke out in hives. EMS was called and epinephrine/diphenhydramine administered for course cough/wheezing, presumably anaphylaxis. Other foods consumed by baby on same day included banana, kids ?g newton bar, dried apples, meat from frozen meal, and two piece of cereal (new to baby). ER course required 4 hours of monitoring but no other medical interventions.
35 2021-03-20 injection site pain, injection site tingling Day of vaccine: fatigue, sore arm at injection site, at 10pm: metallic taste Day after vaccine: Feve... Read more
Day of vaccine: fatigue, sore arm at injection site, at 10pm: metallic taste Day after vaccine: Fever 99.5 for ~2 hours, extreme clumsiness/lack of full control of appendages, muscle aches, and fatigue all day. Sore arm (injected arm), intermittent headaches. At 10pm: swollen lymph node (size of cherry tomato of injected arm). For the next 9 days: arm tingling, as if nerve(s) were pinched, when trying to extend or stretch straight (injected arm) Symptoms caused fair/tolerable discomfort, but not severe.
35 2021-03-20 itchy skin Itching/burning/tingling/numbness in left arm -- pinky and ring finger especially affected. Itchines... Read more
Itching/burning/tingling/numbness in left arm -- pinky and ring finger especially affected. Itchiness spread to neck, chest, other arm, and head. Dissipated after about 30 minutes.
35 2021-03-21 rash with redness 1st injection (2/26): no symptoms 2nd injection (3/19): 24 hours after = headache, lethargic, achy,... Read more
1st injection (2/26): no symptoms 2nd injection (3/19): 24 hours after = headache, lethargic, achy, 100+ fever (lasted about 8-10 hours). 30 hours after = pink rash began to form all around upper arm. became darker pink the following day. currently still have rash 3 full days after 2nd injection.
35 2021-03-21 rash, shingles 72 hours after shot had horrible chest pain on left side of body, same side of the shot. Took Advil ... Read more
72 hours after shot had horrible chest pain on left side of body, same side of the shot. Took Advil and went away, occurred for two days. On Wednesday a rash started showing up and Friday unable to sleep due to rash under left breast to armpit to back following the bra line. Went to the doctor and diagnosed with shingles.
35 2021-03-21 itchy skin, hives I had itching on my neck at the base of my hairline and then behind my ears; hives on torso that spr... Read more
I had itching on my neck at the base of my hairline and then behind my ears; hives on torso that spread to my wrist, then inner elbow, inner thigh and eyelids; This is a spontaneous report from a contactable consumer reporting for herself. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM9810/expiration date: not provided), via an unspecified route of administration, on 13Feb2021 at 13:00 (at the age of 35 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: FL3246/expiration date: not provided), via an unspecified route of administration, on 23Jan2021 at 13:00 (at the age of 35 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was not reported. It was unknown if the patient had any allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021 at 12:45, the patient experienced itching and hives. The clinical course was as follows: "I had itching on my neck at the base of my hairline and then behind my ears and then noticed hives on torso that spread to my wrist, then inner elbow, inner thigh and eyelid". It was reported whether treatment was received for the events was unknown. The outcome of the events itching and hives was recovering. Since the vaccination, the patient had not been tested for COVID-19.
35 2021-03-22 skin warm, redness Second dose, ~ 15 minutes post vaccine...left the building . She experienced redness, warmth & weak... Read more
Second dose, ~ 15 minutes post vaccine...left the building . She experienced redness, warmth & weakness. She was given oral benadryl at her clinic and administered 0.3mg epi x 1 en route by EMS.
35 2021-03-23 skin warm, itchy rash Rash on arm warm to touch very itchy
35 2021-03-24 injection site redness Redness of injection site. It started out small, the size of a quarter and has grown to the size of ... Read more
Redness of injection site. It started out small, the size of a quarter and has grown to the size of softball over the last 4 days. My Mom says its cellulitis and I don't want to die so please call me asap!
35 2021-03-24 injection site swelling, injection site pain, injection site pruritus Swelling, pain at injection site, itching, stiff neck
35 2021-03-25 rash Body rash (not at injection site) 2 days after injection. Trying Benadryl to relieve. Injection date... Read more
Body rash (not at injection site) 2 days after injection. Trying Benadryl to relieve. Injection date 3/24/21, rash appeared 3/26/21
35 2021-03-25 skin warm PFIZER COVID-19 VACCINE EAU. FIVE MINUTED AFTER HER DOSE WAS ADMINISTERED, PATIENT EXPERIENCED DIZZI... Read more
PFIZER COVID-19 VACCINE EAU. FIVE MINUTED AFTER HER DOSE WAS ADMINISTERED, PATIENT EXPERIENCED DIZZINESS, LIGHTHEADEDNESS, AND WARMTH. SHE WAS GIVEN A WATER AND ICEPACK AND FELT BETTER AFTER WAITING ABOUT 15 MINUTES. SHE WAITED AROUND 15 MINUTED LONGER AND SYMPTOMS RESOLVED.
35 2021-03-25 injection site pain Pt. developed reactive supraclavicular lymphadenopathy on 3/23/2021 following her first COVID 19 Pfi... Read more
Pt. developed reactive supraclavicular lymphadenopathy on 3/23/2021 following her first COVID 19 Pfizer vaccination on 3/21/2021 in the ipsilateral arm. Details: Sunday 3/21/21 she received her first dose of the Pfizer COVID 19 vaccine to her left deltoid and the following day on Monday felt tired and a sore left deltoid. On Tuesday her soreness in her left deltoid improved but she still felt exhausted and before going to bed noted a tender bump just above her left clavicle which was tender to touch. Pt. States that it feels like a "jelly bean" size and is mobile, tender and soft to touch. Pt. States that it is much smaller on 3/25/21 than when she first noted it on 3/23/21 and appears to be improving but got concerned. Pt. States that the deltoid soreness resolved but the lump above her left clavicle persisted but she also had a headache all day and still felt tired but also nauseated but denies any vomiting, abdominal pain, changes in bowels, fevers or chills, rashes. Pt. states that3/25/21 she is feeling much better and has more energy and her headache and nausea resolved and that the lump above her left clavicle is still there but smaller in size. Pt. with no hx of lymphadenopathy after any other vaccines in the past. No hx of severe or unusual adverse reactions following immunization in past. Denies any breast or armpit complaints, fever, chills, wt loss, left arm pain or arm swelling at or around the injection site, rashes, sore throat, nasal or sinus symptoms, cough, difficulty swallowing or breathing. Of note pt. states she was ill with COVID 19 like s/s back in April 2020 but at that time testing was not available unless your were hospitalized and her s/s were mild and she self treated at home with supportive care. Pt. States that she got an antibody test 3 months later and had + COVID 19 antibodies and was recently retested for antibodies on 2/27/2021 and they were still positive.
35 2021-03-25 injection site pain Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
35 2021-03-25 redness patient reported blurred vision, and facial redness and swelling around the cheeks. Blood pressure w... Read more
patient reported blurred vision, and facial redness and swelling around the cheeks. Blood pressure was also found to be elevated.
35 2021-03-26 hives Flu like symptoms including fever, chills, fatigue, body aches started after 12 hours and lasted for... Read more
Flu like symptoms including fever, chills, fatigue, body aches started after 12 hours and lasted for 36 hours. Then hives and flushing on day 2-3, intermittently. Swollen lymph nodes in armpit, neck, groin, jaw and tooth pain. Continuous headaches, congestion, and worsening fatigue for weeks. At week 3, started having increased shortness of breath, nocturnal hypoxemia, cough, chest tightness, fatigue, increased heart rate with exertion. These symptoms worsened over the next three weeks.
35 2021-03-26 injection site pain Low grade fever, body chills, headache, injection site pain
35 2021-03-27 redness, injection site pain, itchy skin, rash, hives It did not manifest in a normal way- I started coughing and needed my inhaler, proceeded to feel as ... Read more
It did not manifest in a normal way- I started coughing and needed my inhaler, proceeded to feel as if my legs were covered in fire ant bites and swollen, the skin all over my body itched to the point that I broke the skin, my face became bright red and hivey, and my throat began to tighten as if someone were choking me. The only reason I did not use my Epipen was the fact that I could still breathe through this, even if it was a bit labored. I should add that my reaction began 1.5 hours after I was vaccinated. I?ve been managing having life threatening allergies since I was a child, but this reaction resembled nothing I?ve ever experienced. After using 50 mg of Benadryl, my symptoms were manageable. The pain at the injection site lasted for five days and caused intermittent numbness to my pinky finger and up my neck.
35 2021-04-05 itchy skin, rash Had difficulty breathing and swelling of the back of her throat as well as a skin rash and itching o... Read more
Had difficulty breathing and swelling of the back of her throat as well as a skin rash and itching on her chest. She was given Epi, benadryl, and steroid inhaler by EMS. In ED was started on an epi drip, when the was dced after a few hours patient's symptoms returned. Epinephrine was then restarted and patient was admitted to the hospital.
35 2021-04-14 rash with redness, injection site pain, itchy skin, rash I had pain at the injection site and a headache the following day after the shot then I thought I wa... Read more
I had pain at the injection site and a headache the following day after the shot then I thought I was back to normal. The following Saturday I started to feel itchy and I have a measles or chickenpox looking rash on both arms. Some of the small bumps are red.
35 2021-04-14 injection site pain, injection site tingling Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ARM NUMB ... Read more
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ARM NUMB AND TINGLING FROM SITE OF INJ TO FINGERTIPS-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
35 2021-04-16 rash, hives sinus infection; very uncomfortable; delayed reaction after 38-42 hours or after 48 hours; rash and ... Read more
sinus infection; very uncomfortable; delayed reaction after 38-42 hours or after 48 hours; rash and hives all over her body, not only on the injection site/all over her torso, legs, thighs and looks like hives; rash and hives all over her body, not only on the injection site/all over her torso, legs, thighs and looks like hives; This is a spontaneous report from a contactable nurse (patient herself) via medical information team. A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 intramuscular, administered in left deltoid at age 35 years on 23Mar2021 16:30 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunization (prevention). Medical history included none. Family history of sister that had COVID and then got vaccine. She did not get a rash but is prone to allergies and things like that. Her sister has very sensitive skin and she does get rashes. Her sister got really sick but did not have the things she had. Her sister had COVID pretty bad for a week or 2. Once her sister was COVID negative, she got the first COVID vaccine and did ok. her sister got the second vaccine and got pretty sick like she had COVID again. Patient did not ever get COVID though. There were no concomitant medications. No vaccines administered on same date of the Pfizer suspect and no vaccines administered within 4 weeks. Patient historically took first dose of Pfizer COVID vaccine given on 28Feb2021 at age 35 years, Injected intramuscularly in left deltoid, Lot number: EN6205, expiration date unknown and just had a sore arm after injection, mild discomfort in arm. Patient would like to report an adverse reaction that may be related. Patient got the second vaccine on 23Mar2021 16:30 (Tuesday), and on Thursday afternoon (25Mar2021), she broke out in a rash like hives, pretty much all over her body. Rash and hives all over body was reported as worsened. There was no prescriber for vaccine. She just received it as a part of an initiative. This is a delayed reaction after 38-42 hours or after 48 hours. It was not near the vaccination site. It is all over her torso, legs, thighs and looks like hives. She said "hives in general if in an immuno response to BENADRYL or steroid cream". Patient stated event was medically significant. It is very uncomfortable. She doesn't normally get rashes and this was a new experience for her. Patient had labs done on an unspecified date for a physical and they were all within normal limits, such as her CBC, and CMP. She even got a C-Reactive protein and it was within normal limits. She has not left the house and has not changed detergents and has not done anything different that would cause this reaction. She wanted to know if there have been other delayed reactions like this. She also mentioned taking amoxicillin antibiotics (Lot SM8720051-A, Expiration Mar2022. Dose was 875/125 1 tablet by mouth twice daily) for a sinus infection on unspecified date, and was on the last day and does not know if it would be clinically significant. Outcome of the events 'rash and hives all over her body, not only on the injection site/all over her torso, legs, thighs and looks like hives' and 'delayed reaction after 38-42 hours or after 48 hours' was not recovered, for the other events, it was unknown. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Rash and hives all over body, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Reporter seriousness for Rash and hives all over body: Medically significant.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-04-18 itchy skin Monday had Shortness of breath throat tightness about 20min after inj, tongue felt thick and body wa... Read more
Monday had Shortness of breath throat tightness about 20min after inj, tongue felt thick and body was itchy. 911 had to be called at pharmacy I was taken by ambulance to ER. I was given 2 Epi, 1 solumedrol, 1 albuterol treatment and 02. Then tuesday around 1300 I started to itch. I was driving to get medrol dose back. My became short of breath throat became tight, tongue numb and tingling. I had to call 911 and was taken by ambulance to ER. I was given 2 EPI, solumedrol, 02, 3 IV Benadryl. Thursday around 11am became itchy throat tight and shortness.of breath was driven to ER. I was given EPI, solumedrol, Benadry, and Pepcid. Labs were drawn, Xray, Ct, and ultrasound. I was admitted over night at a different local hospital and taken by ambulance. Monday still slightly itchy and muscular chest pain
35 2021-04-19 injection site pain Extreme 12/10 pain at site as well as complete lack of motion. Pain started before the needle was e... Read more
Extreme 12/10 pain at site as well as complete lack of motion. Pain started before the needle was even removed from arm. This extreme pain and loss of motion lasted 3-4 days and then started to diminish. Pain still persists at a level of 4/10 as of today 4/20, 9 days after shot. Currently have range of motion back but at some spots, pain is evident.
35 2021-04-20 shingles, itchy skin, skin burning sensation I started with a fever, chills and just general flu like symptoms that started the day of my 2nd vac... Read more
I started with a fever, chills and just general flu like symptoms that started the day of my 2nd vaccination(3/25/21) all which I knew I may experience. These started around 9pm on Thursday evening, and subsided by 6pm on Friday 3/26/21. On Saturday 3/27/21 I started to feel pain in my lower back. It wasn?t pain in the muscles it was itching of the skin that turned into a piercing pain that covered my lower back. I contacted my primary care and she said it sounded like shingles and asked if I had a rash. I did not. She started me on Gabapentin 300mg 1 capsule by mouth 3x a day as needed for pain. The symptoms lasted until approximately the evening of Tuesday 3/30/21. No rash ever appeared but the burning/itching/piercing pain is what stayed with me for those 3 days.
35 2021-04-22 hives Severe allergic reaction with hives that started on my face and moved down to my neck and body also ... Read more
Severe allergic reaction with hives that started on my face and moved down to my neck and body also with a cough. Went to Er bc my face felt like it was on fire and they gave me meds and a steroid shot and I know have to take steroids for 3 days along with Benadryl every 6 hours as well.
35 2021-04-24 hives felt a little tingly; Sat down for 15 mins and could not stand up because I was too dizzy; was break... Read more
felt a little tingly; Sat down for 15 mins and could not stand up because I was too dizzy; was breaking out in hives on my face and chest; my throat started closing; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8734) at single dose on 06Apr2021 12:00 in left arm for COVID-19 immunisation. Medical history included fibromyalgia; asthma (controlled). Patient had known allergies to CT contrast and codeine (when taken with albuterol). Concomitant medications in two weeks included pregabalin (LYRICA), baclofen, nortriptyline, vitamin D3. There was no other vaccine in four weeks. Patient got the shot and felt a little tingly and sat down for 15 mins and could not stand up because she was too dizzy. Her daughter (also there receiving the shot) grabbed paramedics to check if this was common. The paramedics helped walk her to their triage room set up maybe 50 yards away. By the time they got there, patient was breaking out in hives on her face and chest. The paramedics started setting up an IV and that was when her throat started closing. Patient was given a shot of EPI while they finished the IV and gave her a bunch of other things in the IV. Patient got another shot of EPI in the ambulance on the way to the hospital and was put on an EPI drip while admitted. Patient stayed in the hospital while they tried several times to take her off EPI, but was not successful until the end of the third day (Thursday night) when she was sent home. Patient returned to hospital Monday and currently still under medical care at home. All adverse events start date was 06Apr2021 12:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The seriousness criteria was hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized 3 days for the events, treatment included medication intervention. There was no covid prior vaccination, covid was tested post vaccination. Novel corona virus test via nasal swab on 13Jun2020 and 22Jun2020 were both negative; COVID-19 RT PCR via nasal swab on 21Jan2021 was negative. The outcome of events was recovering.
35 2021-04-27 injection site hardening, injection site warmth, injection site mass, injection site pain, injection site redness Experiencing what is being described as ?Covid Arm?. Redness at injection site, hard lump, feverish ... Read more
Experiencing what is being described as ?Covid Arm?. Redness at injection site, hard lump, feverish to touch, painful. My arm feels like dead weight and there?s a white hot burning sensation in my shoulder joint. Nausea, dizziness and light headed feeling that comes and goes.
35 2021-04-27 injection site pain Site: Pain at Injection Site-Medium
35 2021-04-28 injection site pain Fever, chills, pain at injection site, tired, nausea, tightness of throat, ear pain
35 2021-05-02 rash, itchy rash After shot one on 4/11 I developed an allergic reaction skin rash on both arms and the thighs of bot... Read more
After shot one on 4/11 I developed an allergic reaction skin rash on both arms and the thighs of both legs. I saw the doctor on 4/29 and was prescribed a steroid cream to help my body get rid of the rash. After my vaccine on 5/2, the rash flared hours after injection and became more prevalent and itchier.
35 2021-05-03 rash, rash with redness Red rash on the tops of both of thighs; the pattern resembled a net or web. It did not hurt or itch ... Read more
Red rash on the tops of both of thighs; the pattern resembled a net or web. It did not hurt or itch or burn, and no other symptoms. Occurred after sitting outside for 2 hours for lunch in the sun (but legs were covered by pants, so not a sunburn). The rash faded slightly and then intensified again over the course of the day/night. The next day it was gone and it has not yet returned. Appeared 8 days after my 2nd vaccine shot (Pfizer).
35 2021-05-03 itchy skin Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generali... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: Patient reported itching all over her body, we gave patient 2 tablets of Benadryl and 2 bottles of water and monitored patient for an additional hour. Patient reported that her symptoms subsided after taking the Benadryl and she was comfortable leaving the pharmacy. She reported that she will be staying at her mom's house in case she required additional assistance.
35 2021-05-04 hives Latent hives; flashing; vertigo; This is a spontaneous report from a non-contactable Other HCP. This... Read more
Latent hives; flashing; vertigo; This is a spontaneous report from a non-contactable Other HCP. This 35-year-old non-pregnant female Other HCP reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on left arm on 27Jan2021 12:00 PM at single dose for COVID-19 Immunization. The patient's medical history and Concomitant medication were not reported. Historical vaccine included first dose of COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. On 29Jan2021, the patient experienced Latent hives, flashing, vertigo. The patient did not receive any treatment but resulted in doctor or other healthcare professional office/clinic visit. The outcome for the event was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
35 2021-05-13 vaccination site pain, redness, itchy skin, rash its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its ki... Read more
its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its kind of itches; lip swelled up on left side; really tired; Dry mouth; soreness at injection site; still had not had periods/ had not yet started her cycle; anaphylactic reaction; rash so it is on her left armpit kind of going towards her chest; swelling; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8736), via unspecified route of administration in left arm on 24Apr2021 at single dose for COVID-19 immunisation. The relevant medical history included react like that normally is it eat bananas or sweet potato, asthmatic. Concomitant medications included vitamins nos. The patient previously took Wellbutrin, Methocarbamol and both experienced drug allergy. The patient previously received first dose of BNT162B2 (Lot number: ER8735) on 02Apr2021 at the age of 35 years old for COVID-19 immunisation and had menstruation irregular. The patient got her 2nd Vaccine that past Saturday and she got it on her left side of her body and her lip swelled up on left side and then she got a rash but the rash was going away and swelling going down but she thought she needed to report that. The patient still had not had periods which was very unusual for her and she tested the pregnancy test and she was not pregnant. Anatomical site of swelling was stated as left side of her lip on her face it looked like she got stung by a bee and then the swelling had been going down on that, the rash was going away as well. When confirmed the event start date, 25Apr2021 was stated for the swelling and rash. For causality the patient stated that she thought so because she was allergic and she avoided she had not got a rash like that from eating them. She also got like swelled lips or hives and she did not get hives and in this period that was the only thing and she had couple of other friends that had biological symptoms too, so that was the reason she was pretty sure it was connected. The patient stated that the swelling and the rash was still there, the swollen lip was going down and she had not yet started her cycle. She also stated that swelling was improved, rash was better but she could still see it. After her vaccine she was really tired and she was sure a lot of people were so she just fall asleep for 12 hours. When she woke up it was a little better. So she did not take anything specifically for that. When described the signs and symptoms of the anaphylactic reaction, the patient stated that it looked kind of well she mean let her look at the rash so its on her left armpit kind of going towards her chest and its kind of scratchy and red in rays its kind of itches over then but its not writhing or sheathing. She was asleep for 12hrs she thought it came up some time either late Saturday night or early Sunday morning. She didn't had any problem in breathing, she didn't have tightness in her chest no racing heartrate nothing like that. No medical intervention required. No Emergency Department and no hospitalization. The patient got dry mouth but again she didn't like super weird, she didn't had any racing heart rate, she did not had any respiratory symptoms, obviously dermatologically did. She would say as reaction go well significantly minor she had soreness at injection site but she didn't had any raised she wasn't raised can't even tell now for that well that fine. No initiation of new medication or other treatment or procedure required. Her husband was positive back in the fall. She was tested but she quarantined from him and she never got it. She tested 4 times negative. The outcome of the event rash, lip swelling and swelling was recovering, while other events were unknown.
36 2020-12-31 injection site reaction, injection site pain, rash papular, rash Skin rash and hyper-pigmentation in the area of the band-aide. Basically a band-aid imprinted rash t... Read more
Skin rash and hyper-pigmentation in the area of the band-aide. Basically a band-aid imprinted rash that burns, very dry. The imprint has not resolved, only increased hyper-pigmentation and raised skin rash.
36 2021-01-01 itchy skin, hives, skin warm Tennis ball size hive that was itching and warm to the touch. This hive came and went 2-3 times over... Read more
Tennis ball size hive that was itching and warm to the touch. This hive came and went 2-3 times over the course of 1 week, each time it got bigger and hotter and more itchy.
36 2021-01-03 skin warm Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issu... Read more
Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issues with armpit or breast tissue. Needed to take Motrin/Tylenol for pain and swelling for two days after vaccination.
36 2021-01-03 hives Hives to opposite arm starting the same day of vaccine, hives continuing to spread over arms, back, ... Read more
Hives to opposite arm starting the same day of vaccine, hives continuing to spread over arms, back, and buttocks 2 weeks from injection date. Currently controlled with benedryl
36 2021-01-03 hives, injection site pain, itchy skin, injection site redness, injection site pruritus, injection site inflammation Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was f... Read more
Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was flushed. At 0930, I developed hives on my neck, chest and arms. I immediately went back to the vaccination site (I was still in the hospital at work) and was administered 25mg oral Benadryl and monitored for 30 minutes. The hives resolved, but I still felt unwell. At 1600 I noticed a swelling in my right upper thigh about the size of my hand. It was about 2 inches inferior to my inguinal crease and was the width of my thigh. It was mildly painful to the touch. My injection site was red, inflamed and itchy. I continued taking 25-50mg Benadryl Q4 and took 100 mg at night due to itchiness on my eyes, face, neck, chest and arms. This is still present, although less each day, as of Monday 1/4/21 morning. I have felt feverish but have not had a recorded fever. I took some Ibuprofen for the pain in my arm at the injection site. The redness, swelling and itchiness has decreased each day at the injection site, but is also still present as of Monday 1/4/21 morning. I still feel unwell and have continued diarrhea throughout the weekend.
36 2021-01-04 injection site pain 12/23/2021 VACCINATION. ACHEY JOINTS, SORE AT INJECTION SITE, FEVER AND CHILLS AT 7PM. CONTACTED PC... Read more
12/23/2021 VACCINATION. ACHEY JOINTS, SORE AT INJECTION SITE, FEVER AND CHILLS AT 7PM. CONTACTED PCP TO SEE IF CAN TAKE IBUPROFREN. CALLED COVID HOTLINE AND THEY REFERRED ME TO CALL MY PCP. 12/24/20210INJECTION SITE SEVERE PAIN, COULDN'T MOVE ARM. 'FELT LIKE STABBING WITH A KNIFE', SOB, AND FEVER AND CHILLS 12/25/2020 COLD SYMPTOMS AND FEVER 12/26/ COLD SYMPTOMS, RUNNY NOSE, FEVER, FATIGUE 12/27/2020 FEVER, SOB, ACHY JOINTS; MILDER SYMPTOMS 12/28/2020 STARTED TO FEEL BETTER
36 2021-01-04 injection site pain Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, los... Read more
Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, loss of strength, tenderness and inability to move arm.
36 2021-01-04 vaccination site swelling, vaccination site pain Injection site is moderately swollen and moderately painful; Injection site is moderately swollen an... Read more
Injection site is moderately swollen and moderately painful; Injection site is moderately swollen and moderately painful; Range of motion is affected; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (Lot Number: EK5730), via an unspecified route of administration in right arm, on 28Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included seasonal allergies, and allergies to sulfa, kiwi, sunflower seeds, and herbal tea. The patient's concomitant medications included paracetamol (TYLENOL), loratadine (CLARITINE), ibuprofen (ADVIL), famotidine (PEPCID), ergocalciferol (VIT D), and ascorbic acid (VIT C). The patient previously took oseltamivir phosphate (TAMIFLU) and nickel and experienced allergies to both. No other vaccine was administered in four weeks. On 29Dec2020 at 11:00 AM, the injection site was moderately swollen and moderately painful and the patient's range of motion was affected (pending clarification). The patient was reporting this because she had never in her life had injection site swelling. The site was not itchy or red. There was no rash. It's just markedly swollen and painful. No treatment was given for the adverse events. The patient did not have COVID-19 prior to vaccination and the patient did not test for COVID-19 post-vaccination. The patient had not recovered from the events.
36 2021-01-04 vaccination site pain Left Red eye; Sore right arm; This is a spontaneous report from a contactable nurse. This 36-year-ol... Read more
Left Red eye; Sore right arm; This is a spontaneous report from a contactable nurse. This 36-year-old female nurse reported for herself that a 36-years-old female patient started to receive bnt162b2 (BNT162B2; Brand: Pfizer; Dose number: 1), intramuscular on 24Dec2020 15:45 at SINGLE DOSE at Vaccine location of Right arm for covid-19 immunisation. Patient was not Pregnant at the time of vaccination. Medical history included Graves disease. Patient had none Known allergies. The patient had no Allergies to medications, food, or other products. Concomitant medication included spironolactone (ALDACTONE), methimazole (METHIMAZOLE) within 2 weeks of vaccination. The patient experienced left red eye and sore right arm, both on 25Dec2020 with outcome of not recovered. No treatment received. The events reported as non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient hasn't been tested for COVID-19. Information on the lot/batch number has been requested.
36 2021-01-04 hives Patient reported breaking out with hives, scattered on trunk and arms, continuing 5 days post vaccin... Read more
Patient reported breaking out with hives, scattered on trunk and arms, continuing 5 days post vaccination. No difficulty breathing or any other symptoms reported.
36 2021-01-04 vaccination site swelling, vaccination site pain Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swel... Read more
Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; This is a spontaneous report from a contactable other HCP. This 36-year-old female other HCP reported for herself that that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular at right arm at single dose for COVID-19 immunisation on 22Dec202008:00 AM. Relevant history included Endometriosis and allergies with Keflex, Levsin. Concomitant drug included bupropion SR which received within 2 weeks of vaccination. The patient experienced shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of neck 4 days after vaccine. Tightness on chest was gradually improving but comes and goes daily for the past week. The events was considered as non-serious. No treatment was received. The outcome of events was reported as recovered with lasting effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 with negative result per Nasal Swab on 23Dec2020. Information on the lot/batch number has been requested.
36 2021-01-04 itchy skin, hives single hive on abdomen (itchy)/full body hives and itching; single hive on abdomen (itchy)/full body... Read more
single hive on abdomen (itchy)/full body hives and itching; single hive on abdomen (itchy)/full body hives and itching; This is a spontaneous report from a contactable Physician. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140, expiry date unknown) intramuscular at left arm on 24Dec2020 at single dose for Covid-19 immunization in a hospital facility. Medical history included Anxiety, Hypertension, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 08Dec2020 for immunization; bupropion hydrochloride (WELLBUTRIN), amlodipine, omeprazole; from unspecified date for unspecified indication. On 25Dec2020, the patient developed a single hive on abdomen (itchy), and on 26Dec2020 the patient developed full body hives and itching but spared the face and mucosal surfaces. The patient has no swelling, no respiratory symptoms. The patient has not been tested for Covid-19 since the vaccination. The patient received treatment of antihistamines (steroids if no improvement) on unspecified date. The hives responded to antihistamines temporarily. The outcome of the event single hive on abdomen (itchy)/full body hives and itching was not recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event hives and itching due to temporal association.
36 2021-01-04 skin spots starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have b... Read more
starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have blood work done to see if I was experiencing anemia. Blood work complete on 12/31/2020. On 1/3/2021, I woke up with blood blisters all over the inside of my mouth and petechia on my trunk and bilateral upper and lower extremities. I called my primary physician to report the symptoms. He suggested to go to the ER if my symptoms worsened. Later that evening I started with a nose bleed and did go to the ER. Upon arrival to the ER, my platelet count was 9. I was admitted to the hospital and diagnosed with ITP.
36 2021-01-04 vaccination site pain woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection si... Read more
woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection site; felt some warmness right after the vaccine, like she felt kind of high; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular at deltoid left on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history included ongoing high blood pressure. Concomitant medication included hydrochlorothiazide/losartan (strength: 25mg/320mg, formulation: tablet), oral one dose form from an unknown date and ongoing, once a day for blood pressure high. The patient previously took flu vaccine for immunization and experienced soreness in her arm and generally felt tired throughout that week. The patient reported that on 23Dec2020 she felt some warmness right after the vaccine, like she felt kind of high (she doesn't know if it was just nerves with this being a new vaccine) and slight soreness at the injection site, on 23Dec2020 at 19:00 she felt her whole arm was sore and on 24Dec2020 she woke up with headache. The patient outcome of the events was unknown.
36 2021-01-05 injection site pain, itchy skin 40 seconds after shot: tingling in left arm and left hand with then wooziness. Tingling itching s... Read more
40 seconds after shot: tingling in left arm and left hand with then wooziness. Tingling itching sensation and mind pain in left arm and hand continued for a few hours then spread into left leg which continued into the next day. Moderate left shoulder tenderness 6 hours after shot lasting 2 days. 6 days after shot severe lethargy, body aches and brain fog which is current on 01/06/21.
36 2021-01-05 hives Facial hives: resolved with PO Benadryl Right eye/cheek muscle twitching (ongoing for 1 week and c... Read more
Facial hives: resolved with PO Benadryl Right eye/cheek muscle twitching (ongoing for 1 week and continuously occurring).
36 2021-01-05 vaccination site pain Fever; Injection site pain; Heart rate up; Body aches; Headache/Head face pounding; Chills; Tired; T... Read more
Fever; Injection site pain; Heart rate up; Body aches; Headache/Head face pounding; Chills; Tired; This is a spontaneous report from a contactable other HCP (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) intramuscularly at left arm on 30Dec2020 at 12:15 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included environmental allergies only. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced fever, head face pounding, heart rate up, body aches, headache, chills, tired, injection site pain; on 30Dec2020 at 06:00 PM. The events were non-serious. No treatment received for events. The outcome of events was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
36 2021-01-05 hives, itchy skin, rash macular No symptoms within 15 minutes of monitoring post vaccination. Reported 1/6/2021. Went home and noti... Read more
No symptoms within 15 minutes of monitoring post vaccination. Reported 1/6/2021. Went home and noticed LEFT arm was itchy. Woke up in the morning with hives running along her left arm. Took an antihistamine and hives reduced to red dots with some residual itching. no other symptoms. no respiratory issues.
36 2021-01-05 injection site pain On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness i... Read more
On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness in my upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. It is now 3pm, about 21 hours since vaccination-fever has broken once (I took ibuprofen at 2pm) but returned but not as high, and severe headache with light sensitivity. The joint pain and numbness has faded but I am left with severe muscle soreness, like I was in a car accident. Oh and I lost taste sometime today. Also I had injection site pain for both doses, starting the morning after.
36 2021-01-05 rash macular, rash Per patient: "I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash fr... Read more
Per patient: "I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash from chest down it was a burning and itching and red spots. They took me to ER and gave me medicine. Within 40 mins I felt better so I left to go home. I have been feeling really tired and weak. I went home on the 4th with weakness and I did vomit 1 time. I felt sick to my stomach all day. I came back to work today still feeling nausiated."
36 2021-01-05 rash Usual sore arm and headache right after the vaccine, followed by body aches, fevers, chills, joint p... Read more
Usual sore arm and headache right after the vaccine, followed by body aches, fevers, chills, joint pains, sore throat, cough, swollen lymph nodes, and now a facial rash.
36 2021-01-06 injection site redness, injection site pain Got vaccine at 1100am Starting at about 1100pm, I developed shaking chills, myalgia, Frontal Headac... Read more
Got vaccine at 1100am Starting at about 1100pm, I developed shaking chills, myalgia, Frontal Headache, nausea. I had redness and soreness at site of injection. Symptoms resolved within 24hrs with help from Tylenol.
36 2021-01-06 itchy skin, hives Hives, itching, wheezing, tachycardia, high b/p, difficulty breathing
36 2021-01-06 injection site reaction, injection site pain Immediately after injection, I felt a warm feeling flow from the injection site and across my chest.... Read more
Immediately after injection, I felt a warm feeling flow from the injection site and across my chest. No shortness of breath or chest pain. Felt slightly light-headed. Drank water and ate some food to closely monitor. Very sore Left deltoid starting about 8 PM on 12/31/20 (same day as the vaccine administration). It was so sore that it woke me up a few times at night and 1/1/21 I had to take Ibuprofen 400 mg to alleviate the pain. Had a dull headache all day 1/1/21 and very tired. Slept that night from 9 pm - 8 am next day. No symptoms since 1/3/21.
36 2021-01-06 rash Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE. Taken to ED from v... Read more
Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE. Taken to ED from vax site. Improved but still with lightheadedness and rash of upper chest. Given IVF and benadryl injx. Observation x 3 hours.
36 2021-01-06 hives, rash SkinRash History of allergy to Fluarix (SOB and hives, treated with Benadryl and recovered); latex a... Read more
SkinRash History of allergy to Fluarix (SOB and hives, treated with Benadryl and recovered); latex and seafood Narrative: Dr. present assessed employee. Mild localized uticaria left upper arm. Resolved after observation 40 min.
36 2021-01-06 hives mucosal erosions and hives
36 2021-01-07 itchy skin, hives, rash 1/4/21: Severe headache, not relieved with OTC meds or prescription migraine meds. 1/7/21: itchy ras... Read more
1/4/21: Severe headache, not relieved with OTC meds or prescription migraine meds. 1/7/21: itchy rash/hives on arm, legs, back and under chin. One dose of Benadryl at that time with no relief.
36 2021-01-07 injection site pain Fatigue, tired, muscle weakness, trouble breathing, pain in site of injection, clouded mind
36 2021-01-07 injection site pain Fever, chills, body aches and pain at the injection. Treatment is Tylenol. Patient will continue to... Read more
Fever, chills, body aches and pain at the injection. Treatment is Tylenol. Patient will continue to monitor
36 2021-01-07 hives Hives everywhere, further described as on the torso; arms; neck; chest; feet; and just the chin area... Read more
Hives everywhere, further described as on the torso; arms; neck; chest; feet; and just the chin area of her face; This is a spontaneous report from a contactable nurse. A 36-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) injection, lot number EL0140, expiration date Mar2021, unspecified route of administration, on 29DEC2020 10:00 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. There were no concomitant medications. nurse reported that they had their Pfizer Clinic on 29Dec2020 and she had a nurse that started having hives on 02Jan2020 after having received the Pfizer COVID- 19 Vaccine on 29Dec2020. The patient reported as everywhere, further described as on the torso; arms; neck; chest; feet; and just the chin area of her face. It was bothersome. Her second dose is scheduled to be administered on 19Jan2021, but she was not sure if she will or will not continue with therapy and receive the second dose. The patient was thinking it could be related but was unsure. Outcome of the event was unknown (reported as unknown but ongoing, hives come and go).
36 2021-01-07 skin discolouration Patient had her first dose of the COVID vaccine and was waiting in the lobby when she asked another ... Read more
Patient had her first dose of the COVID vaccine and was waiting in the lobby when she asked another patient to get help. When staff arrived she was grey, dizzy, having difficulty breathing with rapid respirations and overall not feeling well. Pulse Ox was 88 on room air so she was placed on oxygen and the EpiPen was used. EMS was called. She began improving with the oxygen and after the 0.3mg of Epi. EMS transported her to the ER and at her request her boyfriend was notified.
36 2021-01-07 itchy skin Patient had numbness, itching, tingling in left face. Given Benadryl 25mg, Pepcid 40mg po. symptom... Read more
Patient had numbness, itching, tingling in left face. Given Benadryl 25mg, Pepcid 40mg po. symptoms responded rapidly. No complaints of GI, respiratory, cardiovascular symptoms. Observed almost an hour and a half.
36 2021-01-07 injection site reaction Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ... Read more
Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ice pack and cold cloths. BP was slightly elevated. Pulse initially was about 112. Had patient lay down and she felt better. Thought to be vasovagal response. Starting at 01:30 on 1/7/21 she had a severe headaches, eyes watering, runny nose, dry throat. Injection site reaction
36 2021-01-07 itchy skin Pfizer-BioNTech COVID-19Vaccine EUA I received my shot on 01/06/2021 at 0830 a few minutes after rec... Read more
Pfizer-BioNTech COVID-19Vaccine EUA I received my shot on 01/06/2021 at 0830 a few minutes after receiving the vaccine I became dizzy and lightheaded. I let the nurse in the observation area know and honestly didn't think much of it. It lasted about a minute or two. I was fine for several hours after just experienced the normal soreness and kind of achy tired feeling. Around 1700 I began to itch, my whole right arm and upper torso area was itchy. I did not take any medications for this and it subsided around 2000.
36 2021-01-07 itchy rash moderately itchy rash on chest and burning ears about 1 hour after the vaccine. progressed to mild d... Read more
moderately itchy rash on chest and burning ears about 1 hour after the vaccine. progressed to mild diffuse itching which slowly subsided over the few hours; moderately itchy rash on chest and burning ears about 1 hour after the vaccine. progressed to mild diffuse itching which slowly subsided over the few hours; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) on 05Jan2021 06:15 PM, Intramuscularly at single dose (vaccine location: Left arm) (first dose) for COVID-19 immunization. Medical history included cellulitis of lips due to use of 5 fu (stopped 1 week prior) for actinic keratosis. Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM) from 05Jan2021; amoxicillin, clavulanic acid (AUGMENTIN) from 05Jan2021; bupropion hydrochloride (WELLBUTRIN); escitalopram oxalate (LEXAPRO); magnesium; famotidine (PEPCID); ergocalciferol (VIT D); ascorbic acid (VIT C). There were no Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced moderately itchy rash on chest and burning ears about 1 hour after the vaccine on 05Jan2021 07:30 PM, progressed to mild diffuse itching which slowly subsided over the few hours. Patient did not receive any treatment. The outcome of the events was recovering. This case was assessed non-serious by reporter. The events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
36 2021-01-07 injection site pain soreness at injection site, fatigue, chills, body aches, joint pain
36 2021-01-07 skin discolouration, skin peeling, dry skin vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; ... Read more
vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; It appears I have eye shadow; peeling/dryness of skin around lips; peeling/dryness of skin around lips/It appears I have eye shadow but peeling is not visible; burning and itch of lip region; burning and itch of lip region; muscle spasm; Neuralgia; medium-severe headache; nausea; sensitive to light; mild confusion; lack of concentration; This is a spontaneous report from a contactable nurse (patient herself). A 36-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 28Dec2020 08:30 at a single dose in the left arm as COVID vaccine. Medical history included history of Grave's disease at age 19 which has resolved without medication for many years. The patient had no known allergies: no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient had no other vaccine in four weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not taking any daily medications. On 28Dec2020 (day 1), patient had no significant symptoms. On 29Dec2020 (day 2), patient had medium-severe headache, nausea, sensitive to light, mild confusion and lack of concentration. On 30Dec2020 (day 3), patient had muscle spasm that wake from a sound sleep in biceps tendon region, and neuralgia in left upper and lower extremities. On 31Dec2020 (day 4), patient had peeling/dryness of skin around lips, burning and itch of lip region. On 01Jan2021 (day 5), patient had post vaccination burning, itching redness to eye lids. Patient realized patient should photo her journey. It appeared patient have eye shadow but peeling was not visible due to moisturizer and bacitracin "ito" try and sooth the pain. Patient can send at additional request since patient can't upload. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible". No treatment received in response to the other events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events medium-severe headache, nausea, sensitive to light, mild confusion, lack of concentration, muscle spasm, neuralgia in left upper and lower extremities, dryness of skin around lips, "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible", burning and itch of lip region, post vaccination burning, itching redness to eye lids, and "it appeared patient have eye shadow" was not recovered. Information on the lot/ batch number has been requested.
36 2021-01-08 hives, injection site swelling Developed acute onset eyelid swelling, lip swelling, dyspnea with wheezing and hive like swelling at... Read more
Developed acute onset eyelid swelling, lip swelling, dyspnea with wheezing and hive like swelling at vaccine site. I self administered 8 puffs of albuterol (my prescription) and took 50 mg of oral Benadryl with improvement in wheezing and swelling at injection site. I continue with some mild unilateral right upper eyelid swelling but much improved.
36 2021-01-08 hives Episodic uriticaria started 6 hours after 2nd dose and continue through the 36th hour post vaccinati... Read more
Episodic uriticaria started 6 hours after 2nd dose and continue through the 36th hour post vaccination. Hives occur with very little palpation of skin. Benadryl has been used for symptomatic relief. Chills, low grade fever, and myalgias occurred at 20 hours post 2nd dose and resolved within 8 hours.
36 2021-01-08 rash Mild fatigue and body aches x 1 day, fever started up to 103 and then full body rash. More severe s... Read more
Mild fatigue and body aches x 1 day, fever started up to 103 and then full body rash. More severe symptoms started 1/7-1/8, worsened 1/9. Had close contact with two children and husband, but none have any symptoms.
36 2021-01-09 rash, itchy rash, rash papular Itchy raised rash all over hands and most of legs with rapid heart rate
36 2021-01-09 injection site pain Pain at site of injection, extreme headache, extreme body pain
36 2021-01-10 rash, rash macular Blotchy oddly shaped rash. Not itchy.
36 2021-01-10 injection site bruising Bruise on Injection site
36 2021-01-10 injection site pain I would say the day after mild injection site pain, then at 10 days after mild fatigue and at 14 day... Read more
I would say the day after mild injection site pain, then at 10 days after mild fatigue and at 14 days after a migraine.
36 2021-01-10 hives, itchy skin Over first 15 min after vaccine, face started itching. While in the 30 min observation room, realiz... Read more
Over first 15 min after vaccine, face started itching. While in the 30 min observation room, realized that hives had started on her face, itching on arms but no hives anywhere other than her face She reports that she had the same reaction following the first dose. Reported it to the CDC but not to VAERS. Hives developed 1 hour after vaccine following the first dose Hives started improving
36 2021-01-10 itchy skin, rash Rash that appeared to be urticaria on arms/legs and trunk that appeared around 50hrs post injection ... Read more
Rash that appeared to be urticaria on arms/legs and trunk that appeared around 50hrs post injection and worsened at 72hrs. I am a physician and have seen similar rashes in kids and mine appeared to be consistent with urticaria multiforme. Responsive to Benadryl. I am now day #5 with itching of my palms and faint rash on arms and legs.
36 2021-01-10 injection site pain eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; ... Read more
eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1685) intramuscular at arm left, on 19Dec2020 06:45 at single dose for covid-19 immunisation. Medical history included ongoing acne. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included isotretinoin (ACCUTANE). On 19Dec2020 11:30, approximate 5 hours after vaccine, the patient experienced pain, joint pain and tenderness at injection site, progressively loss of strength and eventually inability to move arm. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was recovered.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-10 injection site pain, injection site redness tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt st... Read more
tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/Her tongue felt strange; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/felt hard to swallow; hot flash; flush feeling all over her face/flush all over her face/she felt flush; arm was sore; arm was sore and heavy; drowsiness; pain and redness at injection site; pain and redness at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 36-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not provided) on 23Dec2020 09:15 intramuscularly in the left arm for COVID-19 immunisation (reported as preventive). There was no relevant medical history and no concomitant medications. The nurse (patient) received her first dose of the vaccine on 23Dec2020 at the hospital that she worked at. She was kept there for 15 min for monitoring and she felt fine. About 30 minutes post vaccination she got a hot flash, a flush over her face, she does not know if she was red but she felt flush. Her tongue felt strange, nothing swelled that she could tell, it felt hard to swallow, to make the motion to swallow it felt kind of sluggish. She felt weird swallowing which lasted for only a few minutes. She never struggled to breathe. She went back to park in the hospital parking lot since she was not sure if she was experiencing a anaphylactic reaction and then after a few minutes it went away. Her arm was sore and heavy feeling for that day. She had drowsiness for a couple of hours and pain and redness at the injection site for a couple of days that was not bothersome, it was mild. No relevant test. She wanted to know if she should get the second dose of the vaccine due to the symptoms she had after the first dose. The pain and redness at injection site was resolved on an unspecified date in Dec2020, while the other events were resolved on 23Dec2020. The reporting nurse considered the events hot flash, flush all over her face, arm was sore and heavy, drowsiness, pain and redness at injection site were non-serious, while the events "tongue felt strange, it was sluggish to swallow" were serious that she drove back to the hospital (no emergency room/phycian office visit). She considered the events were related to the vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162Bw on the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
36 2021-01-11 itchy skin, hives Began itching about 1/2 hour afterwards; Woke up next morning with hives on left forearm and up left... Read more
Began itching about 1/2 hour afterwards; Woke up next morning with hives on left forearm and up left arm; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration on 05Jan2021 12:15 at a single dose on right arm for COVID-19 immunization at workplace clinic. Medical history included anxiety, attention deficit hyperactivity disorder (ADHD), and seasonal allergy from unknown dates. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient reported that she began itching about 1/2 hour afterwards on 05Jan2021 13:00 and she woke up next morning with hives on left forearm and up left arm. The events were non-serious. Antihistamine was given as treatment for the events. Outcome of the events was recovering. Since the vaccination, the patient has not been tested for COVID-19.
36 2021-01-11 injection site redness, injection site pain, injection site hardening Day of shot: she reported "tingling fingers" and "mild fogginess - like I took Benadryl" - declined ... Read more
Day of shot: she reported "tingling fingers" and "mild fogginess - like I took Benadryl" - declined MD assessment (and states this resolved within hours. Day after shot (1/9), she states she noted redness/tenderness at site, fatigue, body aches, fever to 103 (responsive to tylenol; reduced to 99.4 after 8hrs). She presents to AOH 01/12/21 for assessment of L deltoid: 8x8.5cm injection site erythema/tenderness/very mild induration. States fever has resolved; neck/back aches continue; tenderness at site continues. Possible cellulitis? Advised to seek PCP counsel as soon as possible.
36 2021-01-11 injection site warmth, injection site redness, injection site swelling, injection site pruritus Developed severe redness in bullseye formation around the injection site. Peaked in severity 1/10 A... Read more
Developed severe redness in bullseye formation around the injection site. Peaked in severity 1/10 AM with swollen and raised redness, hot to touch, itchy, spreading down the upper arm. Took PO Benadryl and Motrin throughout 1/10-1/11 with improvement. Now mostly resolved.
36 2021-01-11 injection site redness Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the ... Read more
Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the vaccine, she sees gray cloud-like vision, intermittently, usually gets worse during the afternoon.
36 2021-01-11 injection site pain Injection site soreness, axillary lymphadenopathy proximal to injection site, fever (max 102 - tympa... Read more
Injection site soreness, axillary lymphadenopathy proximal to injection site, fever (max 102 - tympanic) lasting for > 4 days poorly responsive to antipyretics, headache, arthralgias, myalgias, neck stiffness/pain, hip pain, low back pain, nausea, anorexia, extreme fatigue, severe chills.
36 2021-01-11 rash Myalgia after vaccine Then rash under (L) arm Appears like Zoster with lesion on back and underarm. ... Read more
Myalgia after vaccine Then rash under (L) arm Appears like Zoster with lesion on back and underarm. TXT with Acyclovir (Herpes Zoster)
36 2021-01-11 rash, injection site hives, redness, injection site rash Patient reported 2 hours after receiving the vaccine that she had a red spot on chest, took benadryl... Read more
Patient reported 2 hours after receiving the vaccine that she had a red spot on chest, took benadryl and zyrtec. Patient reported 30 hours after vaccine that rash had spread to whole chest, back, arms, and injection site and was hive like. Reports also having vivid and crazy dreams, feeling restless the night before.
36 2021-01-11 injection site pain Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and sore... Read more
Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and soreness around injection site. On 1/9- had a severe migraine was unable to get out of bed due to migraine and extreme light sensitivity. Experienced severe muscle aches and chills. 1/10- started experiencing facial swelling especially of the left side. Extreme left eye swelling. With headache. Went to ER. Was given Benadryl to reduce swelling fluids and Prilosec for throat irritation. 1/11-started experiencing left arm numbness and tingling radiating down to fingertips. Experience left side facial numbness and tingling. 1/12- symptoms have begun to improve.
36 2021-01-11 injection site pain Right arm pain (injection site), nausea, chills
36 2021-01-11 vaccination site pain Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering... Read more
Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering if being on Stelera made the symptoms from the COVID Vaccine worse; extreme/ severe fatigue; lightheaded; soreness around injection/Sore arm; felt run down; chills; This is a spontaneous report from a contactable nurse (patient). This 36-years-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via unspecified route at left arm on 21Dec2020 14:00 at single dose for COVID-19 immunization; she also started to receive ustekinumab (STELERA injection), via subcutaneous from 2017 (last injection on 04Nov2020) at unspecified dose every 12 weeks for psoriasis. Medical history was none. Concomitant medications were not reported. No additional vaccines administered on same date of Pfizer vaccine. Historical vaccine included influenza vaccine on Nov2020 for immunization, which was 5 weeks prior to COVID vaccine. Vaccination facility type was hospital. At night of vaccination on 21Dec2020, patient felt run down, thought she had chills. She did not have fever. She woke up next day 22Dec2020 with sore arm/ soreness around injection, was otherwise fine. Day 2, 3, and 4 post vaccine was sick (23Dec2020). She had a sore throat, headache, and extreme/ severe fatigue on 23Dec2020. She was not feeling well/ felt out of sorts on 23Dec2020. She expected to wake up feeling unwell. On 23Dec2020 and 24Dec2020 she felt really bad. Could have been in bed all day. She still did not have fever. She was lightheaded and had a bizarre feeling on 23Dec2020. She woke up 26Dec2020 and felt completely fine. Patient was wondering if being on ustekinumab made the symptoms from the COVID Vaccine worse. Action taken for ustekinumab was unknown. Outcome of events was recovered on 26Dec2020.
36 2021-01-11 injection site pain Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up arou... Read more
Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
36 2021-01-11 injection site pain it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized w... Read more
it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized weakness; temp was 38.1 Celsius; head feels weird; can't sleep; decreased appetite; pain at the injection site; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from Mar2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced body aches, dry mouth, can't sleep, generalized weakness, decreased appetite, and pain at the injection site, temp was 38.1 Celsius, head feels weird in Jan2021. The patient got her first dose and was looking online to see the symptoms. She said that she saw that during the trials, people were experiencing the symptoms she was experiencing after the second dose and she was concerned. She said that she wanted to make sure her symptoms are ok and to make sure that the symptoms are not just caused from the booster, but also from the first dose. The caller said that her mom told her that someone died from the Pfizer vaccine. No further details provided. The patient was having body aches, could not sleep, her mouth is really dry, her temp was 38.1 Celsius, her head feels weird, she has generalized weakness, pain at the injection site, and decreased appetite. She said that it was like having Covid again. She said that she had Covid back in Mar2020. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade. The outcome of all the events was unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the suspected COVID likely represents a pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test is needed for full medical assessment.
36 2021-01-11 vaccination site pain patient complained of severe arm burning upon vaccine administration
36 2021-01-12 itchy skin, redness, rash Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness... Read more
Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness; light-headedness, migraines, irregular heartbeat. She has also noted episodic throat tightness and SOB in the 10 days since the vaccine. She has a history of anaphylaxis w/ morphine. She has an autoimmune condition currently being evaluated by rheumatology. Has Von Willibrands and Hx stroke due to BCP. Will need Allergy Consultation with MD prior to 2nd dose.
36 2021-01-12 redness, hives, rash Received the 2nd Covid-19 vaccine approx 10am, approx 7 hours later she became red, lethargic, felt ... Read more
Received the 2nd Covid-19 vaccine approx 10am, approx 7 hours later she became red, lethargic, felt like she had resistance against her movements, and was "going through jello". She went home, took Benadryl 25 mg, now with rash/hives along various areas, behind her ears. Has an epipen at home but has never had to use. Denies any throat swelling or scratching, no shortness of breath.
36 2021-01-12 injection site pain SOB: 25 min post injection, lasted 1 min then resolved. Nausea 1 hr post dose, intermittent, sever ... Read more
SOB: 25 min post injection, lasted 1 min then resolved. Nausea 1 hr post dose, intermittent, sever x12 hours, then intermittent and mild x1 additional day. Fatigue & pain at injection site.
36 2021-01-12 injection site pain SOB: ~25 min post injection, lasted ~1 min then resolved. Nausea 1 hour post dose, intermittent, sev... Read more
SOB: ~25 min post injection, lasted ~1 min then resolved. Nausea 1 hour post dose, intermittent, sever x12 hours, then intermittent and mild x1 additional day. Fatigue & pain at injection site
36 2021-01-12 injection site pain, injection site pain Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Headache-Mild, Systemic: Eleva... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Headache-Mild, Systemic: Elevated blood pressure. Rose to 140/110. No history of HTN. Returned to patient's normal blood pressure measure of 130/90 30-45 minutes after receiving the vaccine.
36 2021-01-12 hives broke out into hives in my face and neck; short of breath; Exhaustion; This is a spontaneous report ... Read more
broke out into hives in my face and neck; short of breath; Exhaustion; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old female patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 EUA30, lot# EL1284), via an unspecified route of administration in left arm on 28Dec2020 08:45 at single dose for covid-19 immunization. Medical history included Allergies: Penicillin, Bactrim (sulfamethoxazole, trimethoprim), tomatoes. The patient's concomitant medications were not reported. After 25 minutes of getting the first dose of the vaccine, the patient broke out into hives in face and neck. Hives continued for days. By day 3, the patient was checked into the hospital for short of breath, hives and exhaustion. A week after dose 1, the patient still had hives and slight shortness of breath. Pregnant at the time of vaccination: No. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment: COVID test and steroids. If COVID prior vaccination: No. If COVID tested post vaccination: Yes. Covid test post vaccination: Nasal Swab on 01Jan2021, Negative result. Facility where the most recent COVID-19 vaccine was administered: Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: NO. The outcome of all the events was not recovered. Serious: no. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: no. Seriousness criteria-Caused/prolonged hospitalization: no. Seriousness criteria-Disabling/Incapacitating: no. Seriousness criteria-Congenital anomaly/birth defect: no.
36 2021-01-12 redness, itchy skin, hives hives, ears red and swollen, itchy all over
36 2021-01-12 rash papular, rash with redness, rash, itchy rash itchy, fine, erythematous papular rash to face, scalp, chest and back 24 hours after vaccine treate... Read more
itchy, fine, erythematous papular rash to face, scalp, chest and back 24 hours after vaccine treated with benadryl and H2 blocker
36 2021-01-12 vaccination site pain once by injection in the left shoulder/Shoulder pain; Whole body was hurting; Nausea; This is a spon... Read more
once by injection in the left shoulder/Shoulder pain; Whole body was hurting; Nausea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, Batch/lot number: EL3246, expiry: unknown), via an unspecified route of administration on 30Dec2020 at single dose (once by injection in the left shoulder) for COVID-19 immunization (Healthcare worker). Medical history was reported as none. There were no concomitant medications. On 01Jan2021, it was reported that the patient experienced shoulder pain, whole body was hurting, and nausea. Patient asked, after getting the vaccine, if one was able to get COVID, she clarified that she meant after the first dose of the vaccine. She got the typical symptoms and side effects after she got the first dose, like shoulder pain. She is curious if you can still get COVID after the first dose. She is sure you are better off after the second one, but was curious about after the first one. The patient was taking COVID Vaccine because she is a Healthcare worker. Patient is a medical assistant. It was also reported that her shoulder pain was more prominent than her body. She works in the field and people are getting COVID after the first dose of the vaccine. She is concerned on if she could still get it or not. She gets the second dose on 20Jan2021. The outcome of the event once by injection in the left shoulder/Shoulder pain was recovered on 04Jan2021, whole body was hurting was recovered on 02Jan2021, and nausea was recovered on 01Jan2021.
36 2021-01-13 bruising After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection ... Read more
After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection site pain for two weeks. After second Vaccine given at 9:55am. tingling of feet for about 20 mins, 30 mins after the vaccine. Two hours later fatigue, body aches, headache and nausea began. At 0030 1/12/2021 I woke up with severe chills and left chest pain, temp was 101.6 and heart rate was 160. I began to see black and chest pain was severe feeling like i was having a heart atack and was going to pass out so i called 911. I then began to get short of breath and got numbess on my legs, left arm and left side of neck. Chest pressure/pain radiated to left arm and neck. I was taken by the ambulance to hospital. Arrived around 0130. My heart rate sustained at 140s in the ER so I was admitted at 0530 am. My D Dimer was a bit elevated as well as my lactic so I was given a bolus of fluids plus maintenance. I had a CXR done, CTA chest(negative for PE), UA, Labs, entire cardiac workup including an ECHO during my admission. I also began to have loose stools and wrist joint pain. MY heart rate sustained at 125-147 for about 30 hours. Fevers on and off. After everthing was negative we determined this was secondary to the covid 19 vaccine. I was discharged 1/13/2021 at around 1:30 pm. My heart rate is still not at baseline which is 87-90. I'm 100-130 and still get very fatigued with a simple slow walking. Still having tachycardia, fevers, body aches, joint wrist pain, chest discomfort and headaches. My potassium was 3.0 at discharge so will be needing labs in a week. Also bruised a little different than I usually do with lab draws so keeping an eye on them and will be checking my platelets again in a week. Ive been taking tylenol for my fever and pain and ativan for any anxiety when my heart rate goes up. (treatment during hospital stay was normal saline bolus, nomal saline maintenance fluids at 150 cc/hr, tylenol, ativan, ice packs, rest)
36 2021-01-13 rash Body aches, joint pain, malaise, viral rash extending from trunk up my neck and into my scalp, start... Read more
Body aches, joint pain, malaise, viral rash extending from trunk up my neck and into my scalp, started the night of the vaccine and continuing today, two days post.
36 2021-01-13 rash, rash macular Employee received vaccine. Within minutes she had red blotches and a rash on neck and down trunk are... Read more
Employee received vaccine. Within minutes she had red blotches and a rash on neck and down trunk area and coughing/shortness of breath. Employee was administered liquid benedryl for the minor allergic reaction.
36 2021-01-13 hives First 24-48 hours: Riggers, 102 temp, myalgias, fatigue, tachycardia 2-4 days: Diarrhea, low grade t... Read more
First 24-48 hours: Riggers, 102 temp, myalgias, fatigue, tachycardia 2-4 days: Diarrhea, low grade temps, myalgias, fatigue and tachycardia Day 6: new onset of hives all over body, in addition to fatigue and diarrhea
36 2021-01-13 itchy skin Itchy on her right arm and upper right torso area; Dizzy and lightheaded; This is a spontaneous repo... Read more
Itchy on her right arm and upper right torso area; Dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 36-year-old-female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO140), via an unspecified route of administration in right arm, on 06Jan2021 at 08:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to gluten and penicillin (PCN). There were no concomitant medications. The patient previously took cefaclor (CECLOR) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in the patient's workplace clinic. The first dose was given at 08:30 on 06Jan2021. A few minutes after, the patient became dizzy and lightheaded for what seemed like a minute or two and then she was fine for the remainder of her 15-minute observation. Around 17:00 that day, the patient became itchy on her right arm and upper right torso area, no rash or swelling was noted. Itching subsided around 20:00 - almost 12 hours post-vaccine. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 06Jan2021 ("Itchy on her right arm and upper right torso area" at 20:00).
36 2021-01-13 injection site swelling, injection site pain My first dose of COVID vaccine I didn't have any symptoms (1st dose: 12/23/20). Received 2nd dose at... Read more
My first dose of COVID vaccine I didn't have any symptoms (1st dose: 12/23/20). Received 2nd dose at 0800 on 1/12/21. First symptom was on 1/12 at 2000 when I had a headache and malaise so I went to bed early. Woke up at 0200 on 1/13 with nausea, body aches and chills. My temp felt fever-ish (100.4 via temporal scan). So I took Tylenol and Pepto to go back to sleep. Same symptoms carried throughout the morning of 1/13. By noon 1/13 = my L arm where the injection had occurred was swollen, painful and hard to move. That evening I had a presyncopal event where I felt flushed and nearly passed out. My L arm continued to hurt but the swelling moved down into my lymph nodes where lymphadenopathy continues to be a problem until now.
36 2021-01-13 rash, redness, hives Pfizer Vaccine First dose - 12/19/2020 Mild soreness to arm, fatigue Second dose - 1/8/2021 AM of 1... Read more
Pfizer Vaccine First dose - 12/19/2020 Mild soreness to arm, fatigue Second dose - 1/8/2021 AM of 1/10/2021 had small patch of hives on ankle, took zyrtec resolved 1/11/2021 felt ok no symptoms 1/11 to 1/12 night "woke up and had massive allergic reaction everywhere - patches of redness on leg, arms, belly, back, face-sparing" -- took zyrtec and the reaction improved somewhat. Was in clinic so went up stairs and spoke to our dermatologist who thought this was likely reaction to vaccine. Prednisone RX given but has not taken. Takes 1-2 zyrtec daily. Spoke to me on the phone 1/12 at night, increased zyrtec to 4 pills daily, added pepcid and decided to speak today. Did not take atarax or benadryl bc she was on call. Improves with triamcinolone Presents today with worsening rash, she will upload pics in Epic. Areas of urticarial patches from yesterday now have left non blanching purple rash/bruising. More urticarial plaques today. No angioedema. Feels hot has not take temperature. No joint pain or swelling. No oral or vaginal mucosal involvement. No issues with respiration generally but maybe a little tight. >75% BSA involved Allergy history - chronic rhinitis, no known triggers or patterns No history of asthma, eczema, food allergy or drug allergies
36 2021-01-13 hives Scattered hives on torso, bilateral arms/hands, neck and legs
36 2021-01-13 injection site swelling Swollen injection site with higher temperature and swollen surrounding lymph nodes in arm and undera... Read more
Swollen injection site with higher temperature and swollen surrounding lymph nodes in arm and underarm
36 2021-01-13 injection site pain Symptoms - ? EE reports around 5:00 PM began with arm soreness near injection site, at 8:00 PM +lowe... Read more
Symptoms - ? EE reports around 5:00 PM began with arm soreness near injection site, at 8:00 PM +lower back pain, 10:00 PM + body aches and chills, midnight: temp 99.6. Last day of work and shift - ? unsure, EE reported did not work yesterday or today; next scheduled shift tmw Home remedies? - Tylenol 500 mg at midnight and 0600 on 1/14/21 Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE encouraged to rotate Tylenol 500 mg and motrin 400 mg q3h for body aches, EE verbalized back understanding. EE educated to continue to manage per TCH Illness in the Workplace Policy. EE verbalized back understanding and denied further questions at this time.
36 2021-01-13 skin warm Symptoms started approximately 16 hours after receiving the vaccine. Body aches all over including b... Read more
Symptoms started approximately 16 hours after receiving the vaccine. Body aches all over including breast, under arms, legs, feet stomach. Horrible headache that did improve with tylenol and ibuprofen taken at the same time. Body shakes and can't control body temperature. Felt freezing cold but skin was very hot to the touch (according to my husband). Then, I started sweating and felt really hot and couldn't cool down. Felt nauseous but no vomiting. Could not sleep but felt very tired. Today is now 48 hours after vaccine and body aches are gone but I am still extremely fatigued.
36 2021-01-13 hives Tingling to top lip, urticaria which was systemic
36 2021-01-13 itchy rash Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unch... Read more
Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unchanged with use of benadryl.; Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unchanged with use of benadryl.; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunisation. Medical history included depression and celiac disease. Concomitant medications included sertraline hydrochloride (ZOLOFT), omeprazole, calcium, and lactobacillus acidophilus (ACIDOPHILUS). The patient previously took amoxicillin, gluten and experienced allergies. It was reported that the patient had a vaccine received on Monday 04Jan2021, and experienced severe headache afterwards. On Tuesday 05Jan2021, the patient experienced full body itchy rash. These were unchanged with the use of Benadryl. Clinical outcome of the events was not recovered.
36 2021-01-14 injection site pain 13 hours after the injection developed chills, myalgia, fever, rigors. Also local muscle pain at in... Read more
13 hours after the injection developed chills, myalgia, fever, rigors. Also local muscle pain at injection site. Systemic symptoms of fever (up to 101.4F), and myalgia resolved within 24 hours (about 36 hours since the injection). Also developed left axillary lymphadenopathy within 24 hours, which is improving but still some lymph node ttp present after 7 days
36 2021-01-14 injection site pain First approximately 5 hours after receiving vaccine, patient experienced headache and moderate to se... Read more
First approximately 5 hours after receiving vaccine, patient experienced headache and moderate to severe site pain. approximately 12 hours post vaccine, patient experienced nausea, dizziness, fatigue, headache. 3 hours following, patient continued to have the same symptoms along with mild shortness of breath and tachycardia with mild to moderate exertion, such as walking up a flight of stairs.
36 2021-01-14 injection site pain Headache within 15 minutes; fatigue 2-3 hours later, soreness at injection site for 2-3 days
36 2021-01-14 vaccination site pain Headache; muscle pain; fatigue; pain at injection site; This is a spontaneous report from a contacta... Read more
Headache; muscle pain; fatigue; pain at injection site; This is a spontaneous report from a contactable nurse. A 36-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19. Vaccine location was left arm. Concomitant medication included topiramate (TOPAMAX), bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), escitalopram oxalate (LEXAPRO), clonazepam (KLONOPIN). The patient experienced headache, muscle pain, fatigue, pain at injection site all on 09Jan2021. The events outcome was recovering Information on the lot/batch number has been requested.
36 2021-01-14 itchy skin Minor itching of face and neck; This is a spontaneous report from a non-contactable healthcare profe... Read more
Minor itching of face and neck; This is a spontaneous report from a non-contactable healthcare professional (patient). A 36-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, expiry date EL1284), intramuscular on left arm at 07Jan2020 07:30, intramuscular at a single dose for Covid-19 immunization. The patient has no medical history. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously took bnt162b2 as first dose for Covid-19 immunization and experienced severe headache and body ache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 7:45, the patient experienced minor itching of face and neck during the second dose. The patient underwent lab tests and procedures which included nasal swab with negative result on 21Dec2020. There was no treatment received for the adverse events. Outcome of the events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.
36 2021-01-14 itchy skin My face went numb, that was the first symptom 10/15 min after immunization. I got tachycardia (I ten... Read more
My face went numb, that was the first symptom 10/15 min after immunization. I got tachycardia (I tend to have a rapid hart beat but this was pumping pretty good). I also had some GI distress (watery diarrhea) and that lasted for a while. Later I got really weak and shaky, fatigued, that night I woke up with night sweats, and chills, woke up completely drenched, I had to change the sheets and pajamas. 5 days after the vaccine I was really exhausted, the fatigue was awful. There was also an itching sensation but no hives.
36 2021-01-14 rash Symptoms started around 2300 on 01/14/2021. I experienced SOB; sharp and shooting pain throughout m... Read more
Symptoms started around 2300 on 01/14/2021. I experienced SOB; sharp and shooting pain throughout my extremities; dull body aches; nausea induced vomiting; dizziness; weakness. I was unable to sleep throughout most of the night. I used tylenol and ibuprofen for my symptoms which didnt seem to alleviate any of the symptoms during the night. Woke up on 01/15/2021 with a rash on my face.
36 2021-01-15 injection site pain Soreness at injection site, fatigue, body aches and tenderness/swelling at lymph node near collar bo... Read more
Soreness at injection site, fatigue, body aches and tenderness/swelling at lymph node near collar bone on same side as injection site.
36 2021-01-17 hives, redness 1 hour post injection patient returned with redness and borderline hives in her left arm, chest, nec... Read more
1 hour post injection patient returned with redness and borderline hives in her left arm, chest, neck and face. She complained of feeling very hot and with mental confusion. We administered 50 mg of diphenhydramine, and 15 minutes later sent her to the ED. At the ED they diagnosed her with a minor anaphylaxis reaction, gave her methylprednisolone and epinephrine.
36 2021-01-17 sensitive skin, injection site swelling, pain of skin, injection site redness 12-13 hours post second COVID vaccine shot (~2100) started to feel full body pains, lightheadedness ... Read more
12-13 hours post second COVID vaccine shot (~2100) started to feel full body pains, lightheadedness and nausea. Then throughout the night symptoms worsened with significant body chills despite multiple layers, severe body pain and migraine trigger. In the morning felt like full-blown flu with fever of > 100 F, sensitive skin painful to the touch, cold sweats, full body pains, heart palpitations (pounding heart beats and ave 100-120 bpm), and migraine level 8/10. Medication required to try to treat symptoms (metoclopramide, claritin, excedrin). Symptoms continued and did not start to lessen until approximately 30 hours post vaccine dose (18 hours post severe symptom initiation) and two doses of medication regimens. Arm around injection site also showed raised, red irritation local to the site, however, was not exacerbated throughout the symptom course. COVID call center recommended for me to see emergency care facility due to symptoms which I waited to see if symptoms worsened before deciding to not go to the urgent care center.
36 2021-01-17 skin warm, itchy skin, pain of skin, injection site swelling, injection site redness, redness, bruising Friday Jan 15th - arm pain. Saturday Jan 16th - fever of 99.5, chills, no appetite, dehyrdration, sw... Read more
Friday Jan 15th - arm pain. Saturday Jan 16th - fever of 99.5, chills, no appetite, dehyrdration, swelling and redness around injection site, progressed throughout day. Sunday Jan 17th - further swelling and arm pain, lymphnods in underarm area painful and swollen, bruising Monday Jan 18th - Swelling and redness size of palm, warm to touch, painful, itchy
36 2021-01-17 injection site pain Tenderness at the location of injection. Saturday, was soreness under arm (armpit area plus side of ... Read more
Tenderness at the location of injection. Saturday, was soreness under arm (armpit area plus side of body). Sunday started to get soreness in neck on that side of the body.
36 2021-01-17 rash Throat tightening, visible rash, difficulty breathing, changes in phonation, hypotension approximat... Read more
Throat tightening, visible rash, difficulty breathing, changes in phonation, hypotension approximately 10 minutes after receiving vaccination. Given Epi 0.3mg IM X 2 doses, PO Benadryl and transported via ambulance to ED. Left facility with stable vital signs and improvement of symptoms.
36 2021-01-18 injection site swelling, injection site pain, injection site redness Fever; Chills; Body ache; Headache; She had allergic reactions in the area where she took the vaccin... Read more
Fever; Chills; Body ache; Headache; She had allergic reactions in the area where she took the vaccine and today it turned red, hard and really painful. It was swollen; She had allergic reactions in the area where she took the vaccine and today it turned red, hard and really painful. It was swollen; She had allergic reactions in the area where she took the vaccine and today it turned red, hard and really painful. It was swollen; she had allergy reactions; Some spasm in my neck; This is a spontaneous report from a contactable nurse. A 36-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), intramuscular from 05Jan2021 to 05Jan2021 at a single dose for an unspecified indication. Medical history included Hypertension. Concomitant medication included lisinopril. It was reported by the patient that she had side effects of fever, chills, body ache, headache within 24 hours. I received my second dose. She had allergic reactions in the area where she took the vaccine and today it turned red, hard and really painful. It was swollen. She also reported that she had some spasm in my neck and that she had allergy reactions. The patient reported that she took Tylenol as treatment for the events. The outcome of the events was unknown.
36 2021-01-18 injection site pain, injection site redness, injection site swelling Injection site pain, Injection site swelling, Injection site redness, tiredness after injection
36 2021-01-18 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA? Soreness at site of injection Significant muscle aches, chill... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA? Soreness at site of injection Significant muscle aches, chills Moderate fever Minor fatigue Symptoms increased gradually until approximately 8pm Moderate symptoms lasted from 8pm until approximately 12am when fever broke
36 2021-01-18 itchy skin Pre-dosed benedryl 25mg po at 7:00am, due to the previous reaction to covid vaccine number 1, where ... Read more
Pre-dosed benedryl 25mg po at 7:00am, due to the previous reaction to covid vaccine number 1, where she stated she developed hives. Received second vaccine dose at 07:30. Around 7:45 co itchiness, no hives. At 0800, throat itchy, c/o not feeling well, dizzy, b/p144/96, hr88. taken to ER.
36 2021-01-19 injection site pain, injection site swelling, injection site redness Red, swollen, painful, injection site beginning the evening after the second dose. Fatigue a few hou... Read more
Red, swollen, painful, injection site beginning the evening after the second dose. Fatigue a few hours after the second dose. The fatigue continued through the second day after the dose. Headache the day after the second dose. All symptoms were treated with ibuprofen.
36 2021-01-19 redness, itchy skin Symptoms include flushed/itchy face, red patches on face, numb tongue, no fever
36 2021-01-20 injection site pain 1/11@2200 soreness at injection site. 1/12@2045 aching in both feet, left ankle, joints of right fin... Read more
1/11@2200 soreness at injection site. 1/12@2045 aching in both feet, left ankle, joints of right fingers, mod back and thigh pain - all resolved with acetaminophen. 1/17@0100 severe lower back pain. 1/17@1300 pins and needles in bilateral feet that were progressively uncomfortable. 1/18-1/19 severe bilateral foot pain, burning, pins and needles. painful ambulation. Not relieved with any over the counter medications. nausea and retching noted that day. Mild dizziness. Pins and needles progressed up to thighs. 1/20 seen in Emergency Department, neurology consulted. Question of vs vaccine reaction. However discharged home. Symptoms started to decline on 1/21 with less pain and pins and needles. 1/21 minimal pins and needles but muscle cramps in right lower leg and foot more than left leg.
36 2021-01-20 injection site pain Dose #1: Day 1 (after receiving)-fatigue, day 2 & day 3-headache and low grade nausea Dose #2: Day ... Read more
Dose #1: Day 1 (after receiving)-fatigue, day 2 & day 3-headache and low grade nausea Dose #2: Day 1 & 2 (after receiving)-injected arm painful to movement.
36 2021-01-20 rash, itchy skin I had a fever, chills, headache, joint pain in my hands, rash, itching, SOB and a cough two days lat... Read more
I had a fever, chills, headache, joint pain in my hands, rash, itching, SOB and a cough two days later. I did go to the doctor, she did an xray to check for pneumonia.
36 2021-01-21 injection site swelling, injection site pain, injection site hardening, injection site redness As happened with first dose, site of injection got red, hard to touch and painful. Also a small pal... Read more
As happened with first dose, site of injection got red, hard to touch and painful. Also a small palpable bump developed at the site. Symptoms lasted for 5 days approximately.
36 2021-01-21 injection site pain Body aches, fatigue, injection site pain, headache. Improved.
36 2021-01-21 injection site tingling, injection site numbness I received the Covid-19 vaccine on 01/20/2021 and had tingling/slight numbness in my left arm (injec... Read more
I received the Covid-19 vaccine on 01/20/2021 and had tingling/slight numbness in my left arm (injection arm). Later in the evening I had the same feeling in my left leg and in my cheeks, lips, tongue and teeth. I felt like I had been numbed at the dentist, but was coming out of the numbness. It was like when the numbness is mostly gone and you're left with that tingling sensation, and your face feels puffy. It was basically that feeling in my face, left leg, and left arm. Those sensations are mostly gone today (the second day following), but not quite.
36 2021-01-21 injection site swelling Nausea Vomiting Fatigue Muscle aches Joint aches Swollen Lymph nodes in both armpits; more severe sw... Read more
Nausea Vomiting Fatigue Muscle aches Joint aches Swollen Lymph nodes in both armpits; more severe swelling on injection side.
36 2021-01-21 rash, itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA: Patient reported vomiting, nausea, and dizziness soon after va... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient reported vomiting, nausea, and dizziness soon after vaccination. The following day patient developed rash across chest and torso, "slight" itching, fever, and headache and took diphenhydramine. Two days after vaccination patient woke up with swollen armpits bilaterally. Non-steroidal anti-inflammatory drugs improved armpit symptoms. Patient had telehealth visit for symptoms and prescribed Epi-Pen to use when needed.
36 2021-01-21 rash, hives, injection site swelling, injection site redness Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left ... Read more
Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left arm swelling, tingling and discomfort. Pt alert, oriented and denies any respiratory symptoms. Gave Benadryl 25 mg po at 1758 and pt states "50 mg makes me tired and I live out of town". Gave second dose of Benadryl 25 mg po at 1800 when pt began feeling "like my tongue is swelling". Contacted Med ER team to assist with monitoring. Removed pt rings and bracelets on left wrist/hand as pt states "feel like my whole arm is swelling". BP: 122/78 Rt. Arm with apical HR: 60/min and regular. Injection site Left deltoid is not red but swelling noted and spreading. Area is normal temp to touch. Tried ice bag to injection site left deltoid which made it feel worse per pt. The ice made the arm area red. 1818 BP: 136/90. Med team arrived and decision made to transport pt to ED for observation. Pt assisted to wheelchair for transport. Report given to RN from ED. Pt remained alert and oriented throughout. Pt contacted her family herself to notify. Pt received Solumedrol and Famotidine in the ED. Pt was observed and discharged within an hour. Pt follow up with Employee Health provider 1/22/21. Pt continues to experience intermittent rash/hives on chest/neck relieved by Benadryl, Headache, and entire left side feeling tingling and "weird".
36 2021-01-21 shingles Severe headache and neck pain for two weeks. Tired and body ache Shingles on third week
36 2021-01-22 rash papular, itchy skin At hour 12 post vaccination, chills, low grade temp of 99.0, mild headache, body aches, slight fatig... Read more
At hour 12 post vaccination, chills, low grade temp of 99.0, mild headache, body aches, slight fatigue. By hour 21 post vaccination, mild body aches and mild headache, slight fatigue. Noticed a red, non raised rash that mildly itched on my abdomen and outer chest just before my armpits at hour 37 and 45min post vaccination.
36 2021-01-22 injection site pain Warm sensation started from the neck up approximately 30 min after vaccination. Arm soar was began ... Read more
Warm sensation started from the neck up approximately 30 min after vaccination. Arm soar was began about two hours after vaccination, and was felt from the vaccination site to the wrist. This lasted throughout the night. Later in evening stomach cramps , nausea and and migraines began. They next day my shoulder bald and neck muscle were stiff and I was unable to move them. This lasted until day three where no symptoms were present.
36 2021-01-23 injection site pain Body chills, weak, tiredness, headache, joint pain, fever, muscle pain, injection site pain
36 2021-01-23 rash, itchy skin Ichy and rash after seven days of shot
36 2021-01-24 vaccination site pain Arm pain at injection site; Runny nose; Lightheaded; This is a spontaneous report from a non-contact... Read more
Arm pain at injection site; Runny nose; Lightheaded; This is a spontaneous report from a non-contactable physician, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced arm pain at injection site, runny nose, and lightheaded. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of arm pain at injection site, runny nose, and lightheaded were unknown. No follow-up attempts are possible; information about lot number cannot be obtained.
36 2021-01-24 injection site pruritus At 0930 1-21-2021 at the site of her injection on her left deltoid her arm began to itch. Between 1... Read more
At 0930 1-21-2021 at the site of her injection on her left deltoid her arm began to itch. Between 1100-1130 the left side of her jaw began to hurt. She rates that pain 4-7/10. Five minutes later the left side of her lips began to tingle and became numb. She looked in the mirror and saw her face drooping. The Occupational Health Call Center advised her to go the ED. The ED physician told her she did not have Bell's Palsy due to the fact that her eyebrow and cheek were not involved. She was give Toradol and later took Benadryl at home. The ED physician reported to her she had a severe reaction and to monitor for symptoms.
36 2021-01-24 injection site pain Headache, muscle aches, fever of 100F, pain in injection site, nausea, fatigue
36 2021-01-24 injection site pain Injection site pain, headache, nausea, chills, fatigue and fever
36 2021-01-24 rash, injection site rash Rash at injection arm and trunk on that side of body, congestion and fatigue, chills and headaches
36 2021-01-24 rash macular, hives her spot on chest is now hives on chest, back, arms, and at injection site.; her spot on chest is no... Read more
her spot on chest is now hives on chest, back, arms, and at injection site.; her spot on chest is now hives on chest, back, arms, and at injection site.; her chest had a red spot; vivid dreams; restlessness; This is a spontaneous report from a contactable Nurse. A 36-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot# EK9231) vaccine , intramuscular in the left arm on 11Jan2021 08:00 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to azithromycin, morphine and sulfa. Concomitant medication included levothyroxine (LEVOTHYROXINE), liothyronine (LIOTHYRONINE), abaloparatide (TYMLOS). The patient received the first dose of bnt162b2 vaccine on 21Dec2020 . The patient experienced her chest had a red spot on 11Jan2021 10:00 with outcome of unknown , vivid dreams on 11Jan2021 with outcome of unknown , restlessness on 11Jan2021 with outcome of unknown , her spot on chest is now hives on chest, back, arms, and at injection site on 12Jan2021 14:00 with outcome of unknown. The patient received cetirizine (ZYRTEC) and acetaminophen (TYLENOL) as treatment of rash. Further information has been requested.
36 2021-01-25 injection site redness, injection site swelling, injection site pruritus 1530 - receive vaccine 1540-c/o itching at site and hot flashes. Site was red and raised. Sbp 118/... Read more
1530 - receive vaccine 1540-c/o itching at site and hot flashes. Site was red and raised. Sbp 118/75, hr 68, rr 20, sats 97. 25 mg of bendaryl given po. 1344 - hr 69. HR ranged from 68-70 1550-walked in hallway. 1550 - hot flashes ended. Injection site remained red and itchy 1600-pt dcd home
36 2021-01-25 vaccination site pain fatigue; headache; injection site soreness; This is a spontaneous report from a contactable other he... Read more
fatigue; headache; injection site soreness; This is a spontaneous report from a contactable other health care professional. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 12Jan2021 16:00 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included Idiopathic intracranial hypertension. On 12Jan2021 20:00, the patient experienced Fatigue, Headache, Injection site soreness. The patient did not receive treatment for the events. The outcome of the events was recovering.
36 2021-01-25 itchy skin, redness, vaccination site redness minor allergic reaction in forearms; they were red; my body was a little bit itchy; left forearm was... Read more
minor allergic reaction in forearms; they were red; my body was a little bit itchy; left forearm was more redder than the right because that's where I received that vaccination; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in left arm on 08Jan2021 11:00 at single dose for COVID-19 immunization. No medical history and concomitant medications reported. The facility where the most recent COVID-19 vaccine was administered was in the Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, Nasal Swab: negative on 09Jan2021. The patient stated, "I received the shot at 11 am and broke out in a minor allergic reaction in my forearms around 4pm, they were red and my body was a little bit itchy. The left forearm was more redder than the right because that's where I received that vaccination" in Jan2021. The outcome of the events was recovered on unspecified date. The patient took Benadryl as treatment for the events. Information on the Lot/Batch number has been requested.
36 2021-01-25 vaccination site warmth, vaccination site pain, vaccination site redness, vaccination site mass, itchy skin warm to touch; Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on s... Read more
warm to touch; Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on same day as injection; Severe burning with injection followed by mild soreness at arm; Severe burning with injection followed by mild soreness at arm; redness; moderate soreness; Itchy; This is a spontaneous report from a contactable Other HCP (patient). This 36-year-old female (not pregnant) patient received 2nd dose of BNT162B2 (Covid vaccine, lot number=EK4176 on 09Jan2021 09:30 AM on Left arm for covid-19 immunization. Medical history was migraines. Concomitant drug was sumatriptan succinate (IMITREX) for migraines, ethinylestradiol norgestimate (SPRINTEC). Historical Vaccine was 1st dose of BNT162B2 on 19Dec2020 08:15 AM (lot number=EK 5730, vaccine location=Left arm) and experienced moderate soreness at injection site only x2 days. It was reported that patient experienced Severe burning with injection followed by mild soreness at arm. Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on same day as injection. 10Jan2021 - moderate soreness. Area remains bright red, raised, warm to touch increased in size to 1"x1" 24 hours after vaccine. 11Jan2021 - 48 hours post vaccine area further enlarged to 2"x2". Moderate soreness. Itchy. Warm to touch. Palpable area extending to edge of redness. 12Jan2021 - 72 hours. No soreness except when touching injection site. Redness less in color and size. No longer itchy. Palpable lump smaller. Quarter size. Treatment was Tylenol. Outcome of the event palpable lump, Redness was recovering, for itchy was recovered, for other events was Not recovered. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are needed. No further information is expected.
36 2021-01-26 itchy skin, injection site pain 1/18/2021- injection right arm 1/19/2021- mild pain at injection sight. Body aches. 1/20/2021- mild... Read more
1/18/2021- injection right arm 1/19/2021- mild pain at injection sight. Body aches. 1/20/2021- mild pain and muscle stiffness at injection sight. Chills and body aches. 1/21/2021woke up with itching on left side of face a scalp. 1/22/2021 itching subsided 1/23/2021- left side face drooping started.
36 2021-01-26 injection site pain 12 hrs post injection: stiff shoulders/neck/arm (at injection site) and headache 18 hrs: migraine, ... Read more
12 hrs post injection: stiff shoulders/neck/arm (at injection site) and headache 18 hrs: migraine, muscle pain, chills 24-36 hrs: fever (100-102 Fahrenheit), migraine, muscle pain/fatigue, joint pain, increased skin sensitivity/pain to the touch, chills/sweats, shortness of breath, nausea 37-48 hrs: fever broke, continued headache/muscle pain and fatigue, exhaustion at 51 hrs: headache, muscle stiffness, pain at injection site
36 2021-01-26 skin discolouration All over the left side of my chest and down my left arm, you can now see a lot of my veins (dark blu... Read more
All over the left side of my chest and down my left arm, you can now see a lot of my veins (dark blue). You couldn?t see them before injection and you can?t see them at all on my right side. The area, including my underarm and chest are sore.
36 2021-01-26 injection site warmth, injection site swelling, injection site redness Chills on the evening of injection. The next day 1/26/21 - 100.2 fever, headache, body aches- 600mg... Read more
Chills on the evening of injection. The next day 1/26/21 - 100.2 fever, headache, body aches- 600mg of ibuprofen taken once around 8 AM. Fever and body aches improved post ibuprofen, headache persisted. Evening of 1/26/21 fever seemed to return at 99.1 but resolved the morning of 1/27/21. Injection site reaction of warm, red, slightly raised bump noted on the AM of 1/27/21- no action taken at this time
36 2021-01-26 injection site pain, injection site redness, injection site pruritus Fever, body aches, headache, red/itchy/sore knot at injection site
36 2021-01-26 hives Hives Dizziness Nausea
36 2021-01-26 itchy skin, injection site redness Itching of chest and arms, Redness at injection site, Lightheaded 15min after vaccine
36 2021-01-26 redness, skin warm, hardening Red hot half dollar size painful lump, went away came back as red itch half dollar size lump.
36 2021-01-26 rash Small rash to left arm; This is a spontaneous report from a contactable nurse (patient). A 36-year-o... Read more
Small rash to left arm; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number Eks730, expiration date unspecified), via an unspecified route of administration on 23Dec2020, at 08:00 at single dose (left arm) for COVID-19 immunization. Medical history included COVID-19. The patient had no known allergies. The patient's concomitant medications were not reported. On 24Dec2020, at 07:00, the patient experienced small rash to left arm. There was no treatment for the event. The patient had no other medications in 2 weeks. It was reported that the patient had Covid prior vaccination and patient was not Covid tested post vaccination. Outcome of event was recovered on an unspecified date.
36 2021-01-26 rash right armpit and axilla swelling, pain in lymphnodes; right armpit and axilla swelling, pain in lymp... Read more
right armpit and axilla swelling, pain in lymphnodes; right armpit and axilla swelling, pain in lymphnodes; headache; fever; fatigue; Vomit; Dizzy; rash not sure first time but within first 12 hours over chest and trunk; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 36-year-old female patient received second dose (lot number: Ek9231) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 36-years, on 08Jan2021 19:00 (07:00 PM) at single dose in right arm; first dose (lot number: Eh9899) on 18Dec2020 07:00 PM at single dose; both via unspecified route of administration for COVID-19 immunisation in hospital. Medical history included thyroid issues; allergies to latex and adhesives. No COVID prior vaccination. No other vaccine in four weeks. Patient is not pregnant. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA). The patient previously took thimerosal and experienced allergy to it. On 08Jan2021, the patient experienced vomit and dizzy within 1 hour of vaccine. Rash not sure first time but within first 12 hours over chest and trunk. On 09Jan2021 (next day) headache, dizzy, fever, fatigue. On 11Jan2021 (after 2 days), right armpit and axilla swelling, pain in lymphnodes. It was unknown if treatment was received or not. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. No COVID-19 tested post vaccination.
36 2021-01-27 redness Client felt her heart was "Racing" and felt dizzy and light headed. Vital signs were elevated but ... Read more
Client felt her heart was "Racing" and felt dizzy and light headed. Vital signs were elevated but no anaphylaxis or stridor. Client lowered to the floor and cooling measures initiated as face and neck reddened. Controlled breathing initiated with client responding positively with Blood pressure lowering along with pulse. Client did re enter the facility after leaving briefly following resting for a while. On re-entering stated she felt the same as before. Recovered quickly and was able to leave feeling better, but not quite back to baseline. Client had a light sugary breakfast before a work out then came to get her second shot. Advised to follow up with her physician if she became symptomatic again, Also advised to eat on leaving. Instructions understood by client.
36 2021-01-27 rash Rash began day 1 and resolved by day 2. Joint pain day 1-3. Fatigue and diarrhea.
36 2021-01-27 itchy skin Sore arm, itchy arm, headache, sneezing, runny nose, fatigue. Started approximately two hours after ... Read more
Sore arm, itchy arm, headache, sneezing, runny nose, fatigue. Started approximately two hours after administration.
36 2021-01-28 hives, redness, itchy skin Directly after, bright red/ hot ears, itchy face, tingling face and lips Some hives later Severe hea... Read more
Directly after, bright red/ hot ears, itchy face, tingling face and lips Some hives later Severe headache and nausea the next day
36 2021-01-28 vaccination site pain Numbness and tingling in left arm; Numbness and tingling in left arm; Strong pain in left forearm; F... Read more
Numbness and tingling in left arm; Numbness and tingling in left arm; Strong pain in left forearm; Feels like she had hit her funny-bone and the effect was lasting quite a while.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) via an unspecified route of administration on the left arm on 14Jan2021 15:30 at single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. There were no concomitant medications. No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had not COVID tested post vaccination. The patient experienced numbness and tingling in left arm, strong pain in left forearm, feels like she had hit her funny-bone and the effect was lasting quite a while, all on 14Jan2021 17:00. Next day, still tingling and numbness in left arm. No treatment received for the events. The outcome of the events was not recovered.
36 2021-01-28 rash Watery diarrhea and rash
36 2021-01-28 itchy skin reports being vaccinated on 1/22/2021. on 1/26/2021 patient reports having itching that occurred. ... Read more
reports being vaccinated on 1/22/2021. on 1/26/2021 patient reports having itching that occurred. unsure if related to pfizer vaccine or from eating out on 1/26/2021.
36 2021-01-29 injection site pain I received the Pfizer COVID vaccine on Wednesday, January 20th at 1:15 PM. After I got the vaccine, ... Read more
I received the Pfizer COVID vaccine on Wednesday, January 20th at 1:15 PM. After I got the vaccine, I went in to the observation tent for observation. I sat down and immediately felt a tingle sensation in my fingers on my left hand and my arm hurt at the injection site on my left arm. After I left the observation and returned home, the rest of the day/night, my left arm hurt where I received the shot, I had a headache, my neck hurt, and I felt a little nauseous. The next day, January 21st, I felt a slight tingle sensation in both my hands and feet on my left and right side. January 22nd, the slight tingle sensation in both hands and feet on my left and right side continued, and I had a very bad headache. The slight tingle sensation has continued along with some muscle soreness in my arms and legs. The tingle sensation is intermittent throughout the day in my fingers and toes. I have no numbness and it is not painful. It is just a slight minor tingle sensation. I messaged my doctor on January 25th and was advised to monitor it and contact back if it doesn't go away. Present day January 30th, I still have slight tingling sensation in my fingers and toes on my left and right side, the muscle soreness has since subsided.
36 2021-01-29 itchy skin, redness swelling Increasing Redness Itching
36 2021-01-30 injection site redness, injection site pain, injection site swelling 1/22: dizziness, chills, hot flashes, diarrhea, nausea for 6 hours. Exhaustion rest of night 1/23: e... Read more
1/22: dizziness, chills, hot flashes, diarrhea, nausea for 6 hours. Exhaustion rest of night 1/23: exhaustion, anxiety 1/24: spotting- beginning of period (have not had a period since august 2020) tires, lack of appetite 1/25: period, hot flashes, tired, lack of appetite 1/26: felt better in terms of energy, had period 1/27,28: diarrhea each morning 1/28: swollen, painful lymph node under right arm 1/29: pain at injection site, small red bump, slightly swollen arm 1/30 1/31: diarrhea in the morning Continued lack of app since vaccine
36 2021-01-30 injection site tingling, injection site pruritus, skin warm, injection site rash, redness, injection site redness Pfizer COVID-19 Vaccine EUA Event Description: Patient at hospital to receive her first dose of Pfiz... Read more
Pfizer COVID-19 Vaccine EUA Event Description: Patient at hospital to receive her first dose of Pfizer Covid vaccine in left deltoid at ~1105. ~15 minutes after administration c/o leftl arm feeling hot and appearing red. Patient was observed for 45 minutes and given Benadryl 25 mg IM, Solumedrol 125 mg IM, and Pepcid 20 mg po. The redness on her arm increased and her BP and pulse continued to be elevated. She was transferred to ED for further evaluation a 1148. patient walked to ED to be evaluated for allergic reaction. Pt. reports having an 1100 vaccine appointment. Pt. received vaccine, then c/o left arm redness/swelling. HISTORY OF PRESENT ILLNESS: patient is a 36y female who presents to the ED with an allergic reaction. Pt reports she received the Pfizer COVID-19 vaccine this morning at 1100, first dose, and noted a rash along the left arm where the injection site was. Pt notes she received the first dose of the Pfizer vaccine. Pt documents a rash along the left arm which she described as "itchy and tingling." Patient initially had an area of redness following the injection site and then it extended down her entire arm to the wrist. She states that she was wearing a tighter shirt and they had her change into a loose scribed top. Patient denies any tongue swelling, throat swelling, itching, sneezing, syncope, presyncope, chest pain, shortness of breath double cough, nausea, or vomiting. No prior history of allergic/anaphylactic reactions. Patient was monitored for 1 hr and had significant improvement of symptoms. She was discharged in good condition and to return with any new, concerning, worsening symptoms. Advised to follow up with PCP in 2-3 days. Dx: acute allergic reaction to COVID-19 Vaccine Provided Rx for Benadryl and Pepcid Seen by PCP 1/22/2021 and internal reported filed, prompting VAERS report
36 2021-01-31 rash with redness, rash, skin irritation, itchy skin Nausea Flu like symptoms- aches, chills, fatigue SEVERE RASH- all over body- red and inflamed ITCH... Read more
Nausea Flu like symptoms- aches, chills, fatigue SEVERE RASH- all over body- red and inflamed ITCHY- uncomfortable ER VISIT - Hospitalized Medicine- Prednisone, Zyrtec, Pepcid
36 2021-01-31 injection site pruritus, rash, injection site redness Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other th... Read more
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild
36 2021-02-01 itchy skin, redness Agitation, anger, sore arm, lump on arm, redness, extreme itchiness.
36 2021-02-01 injection site mass Flu like symptoms approximately 8 hours following. Chills, headache, body aches. Large, hard lump at... Read more
Flu like symptoms approximately 8 hours following. Chills, headache, body aches. Large, hard lump at injection site. 12 hours following vaccine, severe edema in Left Axilla. Multiple swollen lymph nodes and general edema. Unable to put arm down. Symptoms subsided after 48 hours, but are pain and mild swelling are still present.
36 2021-02-01 rash I have tiny little bumps all over my face, chest, hands and arms. I am not sure that is is related b... Read more
I have tiny little bumps all over my face, chest, hands and arms. I am not sure that is is related by the vaccine is the only thing different I have done/had over the last 10 days.
36 2021-02-01 redness, skin spots Vaccine administered by RN on 2/02/2021 at 11:50am. Location was at Nursing Home. Coordinating fac... Read more
Vaccine administered by RN on 2/02/2021 at 11:50am. Location was at Nursing Home. Coordinating facility for vaccines is the Health District. Within five minutes after vaccine administration, the patient's co-worker informed the patient that she had some redness on her neck. Patient left dining hall where vaccines were being administered and upon return, RN with HD asked patient how she was feeling. The patient was noted to have a red neck and chest with some petechiae on neck and chest. Patient c/o headeache and numb right arm, same arm used for vaccine. At 12pm, 25mg PO of Diphenhydramine was given by RN. The patient c/o nausea and started to vomit. HR was assessed by RN at a radial rate of 106 BPM. Patient stated her head was hurting worse and continued to vomit. RN, called EMS. Cold compress given to patient and patient was assisted to restroom by RN. Upon exiting the restroom, patient started vomiting again and stated her throat was itching and tongue felt swollen. She stated she was allergic to vanilla and her throat felt the same as when she reacts to vanilla. RN, attempted to visually inspect the patient's throat/tongue/mouth and noted that back of the mouth was edematous and unable to visually see the throat. 12:11 pm, 0.3 mg of epinephrine administed by EPIPEN into right lateral thigh. EMS arrived at 12:15pm. Patient assessed by EMS and agreed to transport to Hospital for evaluation. EMS and RN assisted patient to stretcher for transport. Nursing Supervisor, with Health District notified by phone by RN.
36 2021-02-01 hives, redness Welts / redness on face 11:55pm 2-1 benadryl Weak 2 -1 Welts/ redness on face 8pm 2-2 benadryl Sore... Read more
Welts / redness on face 11:55pm 2-1 benadryl Weak 2 -1 Welts/ redness on face 8pm 2-2 benadryl Sore neck, stiff Weak
36 2021-02-01 itchy skin, redness, sensitive skin pt stated that she had an overall itchiness on both feet that were swollen and red like a neuropathy... Read more
pt stated that she had an overall itchiness on both feet that were swollen and red like a neuropathy effect. Pt states it is better now but still has some tingling and sensitivity on both feet. Pt has not contacted PCP at this time.
36 2021-02-01 skin warm swollen arm with heat , for 2 days ,nausea 5 days, fever to 100.1 1 day broke with med-advil muscle ... Read more
swollen arm with heat , for 2 days ,nausea 5 days, fever to 100.1 1 day broke with med-advil muscle aches from neck down 5 days, fatigue 5 days, severe abdominal pain stabbing for 5 days went to ED and IBS flare up also
36 2021-02-02 hives Breastfed son have severe hives x5days
36 2021-02-02 injection site pain Chills, sweats, vertigo, joint pain (particularly in my knees) , muscle pain, extreme exhaustion, li... Read more
Chills, sweats, vertigo, joint pain (particularly in my knees) , muscle pain, extreme exhaustion, lightheadedness, swelling of my extremities, injection site soreness felt like my heart was beating irregularly, cotton mouth, decreased appetite, mental fog. These all started about 12 hours after vaccination and lasted for 2 whole days. Additionally, on Jan 31st, I experienced numerous occasions of "pins and needles" in my feet. This went away and came back over several hours of time throughout the day on Jan 31st. Exhaustion and mental fog have continued through 2/3, but all other symptoms have resolved.
36 2021-02-02 injection site pain Immediate upper pain at injection site. Approximately 3 hours later, feeling of dizziness and feelin... Read more
Immediate upper pain at injection site. Approximately 3 hours later, feeling of dizziness and feeling lightheaded. 12 hours later, extreme fatigue, increased dizziness and feeling lightheaded. 24 hours later, feeling normal again.
36 2021-02-02 injection site pain NauseaVomiting Pain at injection site radiating to elbow
36 2021-02-02 injection site pain Within 24 hours I felt flu like symptoms. Complete body aches, chills, fever of 102.8 (highest), swe... Read more
Within 24 hours I felt flu like symptoms. Complete body aches, chills, fever of 102.8 (highest), sweeting and fatigue. Site soreness was present. Severe headache for 2 days.
36 2021-02-02 rash pt may have allergic reaction to COVID injection, pt had second injection this past friday. rash to ... Read more
pt may have allergic reaction to COVID injection, pt had second injection this past friday. rash to arms, swelling/tenderness to lt arm. pt on routine allergy medicine at home.
36 2021-02-03 itchy skin I received my vaccine at 1:10pm. As I was waiting afterwards, I started getting really itchy around ... Read more
I received my vaccine at 1:10pm. As I was waiting afterwards, I started getting really itchy around 1:25pm. I have a lot of medicinal allergies and this is my normal response when I have a reaction. The itching gradually got worse and some swelling started as well. Around 1:45pm my throat started swelling and I was having trouble swallowing. This continued to get worse, so I stopped at the ER on my way home. I was given Benadryl in an IV and observed for 2 hours. The swelling in my throat went down by 2:45, but the itchiness continued until around 5pm. That evening, the only symptom left was fatigue.
36 2021-02-03 rash with redness, rash Patient developed a rash on both arms, neck and chest after vaccination. Rash was erythematous but ... Read more
Patient developed a rash on both arms, neck and chest after vaccination. Rash was erythematous but not hives. Patient received benadryl, pepcid, and transported by EMS to nearest ED.
36 2021-02-03 redness, hives hives from the neck to legs; Face redness; tightness in the chest; unable to take a deep breathe; Th... Read more
hives from the neck to legs; Face redness; tightness in the chest; unable to take a deep breathe; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscular in left arm on 12Jan2021 11:00 to at a single dose for COVID-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On 12Jan2021 11:00, hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe. The outcome of the events was recovered with sequelae. The events resulted in an emergency room/department or urgent care. Treatment for the events included Benadryl, Ativan, Pepcid, NS Bolus and EpiPen. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested with COVID-19 post vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including physical examination with vitals and chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-02-04 injection site pain 1st dose: intense but bearable pain at the injection site 2nd dose: 2/3/2021 10:05am: similar pain ... Read more
1st dose: intense but bearable pain at the injection site 2nd dose: 2/3/2021 10:05am: similar pain at injection site, left neck stiffness and bearable palpitations (thought to be due to nervousness)immediately following shot, by 10:30pm fatigue and headache(took Tylenol) woke up at 2:00am next day with similar pain, re-dosed Tylenol at 5:50am on 2/4/2021. Slept entire day. Appetite normal. Next day 2/5/2021 12:30p left house to travel to market and couldn?t remember how to get there, had to slowly return home. Called family member to make them aware as I tried to safely return home. Couldn?t immediately recount events or where exactly I was or where I had been. Writing this is increasingly confusing and taking longer than usual.
36 2021-02-04 hives, injection site reaction Fever 103.5, whelp on injection site , migraine, muscle tightness in neck and back, soar throat, dr... Read more
Fever 103.5, whelp on injection site , migraine, muscle tightness in neck and back, soar throat, dry cough
36 2021-02-04 vaccination site pain Sore and swollen lymph node in neck; Sore and swollen lymph node in neck; Tired; Arm I was injected ... Read more
Sore and swollen lymph node in neck; Sore and swollen lymph node in neck; Tired; Arm I was injected is sore; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on 20Jan2021 (14:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient had no relevant medical history and concomitant medications. The patient was not pregnant at the time of vaccination. On 20Jan2021 (17:30), at night on the day of vaccination, the patient had sore and swollen lymph node in the neck; was tired; and the arm she was injected in was sore. The patient did not receive any treatment for the reported events. The outcome of the events, 'sore and swollen lymph node in the neck', 'tired' and 'arm she was injected in was sore', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
36 2021-02-04 injection site pain, hives hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; diffi... Read more
hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; difficulty breathing (wheezing); difficulty breathing (wheezing); injection site soreness; She was hot, flush; difficulty swallowing; the tongue started swelling/Swollen tongue; Anaphylactic reaction/anaphylaxis; This is a spontaneous report from a contactable consumer reported for self. This 36-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 12:52 left arm at single dose (Lot: EL3247) for covid-19 immunisation. Medical history included ongoing Anaphylaxis to Walnuts, Oranges, and morphine, ongoing allergy to a steroid cream Kenalog, and a steroid powder which she broke out immediately and ongoing Colitis. Concomitant therapy was none. She received the first dose of the vaccine yesterday on 20Jan2021 12:52 and 10 minutes later (20Jan2021 13:02) the tongue started swelling/Swollen tongue so they gave her Benadryl to try to stop it but it didn't help enough, hives started to appear on her body so they gave her a dose of epinephrine in the right arm and put on an IV, because she was feeling nauseous and dizzy. She started to feel better and was transferred to the hospital, when she was in the hall of the hospital she started having difficulty breathing (wheezing) and difficulty swallowing so she received another dose of Epinephrine (EpiPen) and also Benadryl, Prednisone and Pepcid. She went home and was taking Prednisone (1 daily), Benadryl and salbutamol (twice daily). She went into anaphylaxis within 15 minutes of receiving it on 20Jan2021. She brought 2 Epi injections with her. They monitored at the hospital for a few hours. She knows exactly how it happened. She was sitting in the observation room. She had told them multiple times that she had allergies before. She came in with two Epi pens and Benadryl. She let them know that as well. She was very verbal that she has history of anaphylaxis. They gave it to her. They said they were going to monitor her for 30 minutes. Her tongue started to swell 10 minutes after. She was sent to the paramedic tent. She took liquid children's Benadryl to try to stop the reaction. It did not help. She clarified it just didn't work enough to delay it. She doesn't have UPC, but provided the following information from the bottle: PLD-H242C LB004314 Lot WJ00896 Expiration Feb2023. She then started getting hives on her neck. She was hot, flush, and dizzy. She felt like she was going to throw up. That passed. They then gave her Epi in the opposite arm, her right arm. She got the COVID vaccine in her left arm. Then, they got her ready to go to the hospital. The transfer was smooth. She was waiting for intake when she started to not be able to swallow. She complained quickly. The nurses ran to get Epi, but the paramedic grabbed the patient's Epi pen and injected it in her thigh. She was IVed up at the vaccine center before transfer. They gave her Benadryl, Pepcid, and methyl prednisone. The Epi pen they gave her was her own shot. They monitored her a few hours. Then sent her home with Pepcid, more Epi pens, and Prednisone for 4 days. She has had normal soreness in her arm at the injection site. It has been status quo, it feels like a tetanus shot. She still has swelling in tongue, but they told her that might take a day or two to go away. She is supposed to also take Benadryl for the next 2 days. She was given the vaccine at the (Place name). Events visit to Emergency Room. They did a CBC and she was in normal range for everything. Lab data included on 20Jan2021: CBC normal. Outcome of the event Swollen tongue was recovering. Outcome of the event Anaphylactic reaction/anaphylaxis was recovered. Outcome of the event injection site soreness was not recovered. Outcome of the events was unknown.
36 2021-02-06 skin irritation Severe photo dermatitis on sun exposed skin.
36 2021-02-06 shingles Shingles
36 2021-02-06 skin discolouration bottoms of both feet turned dark brown third day (normal reactions first and second day like low fe... Read more
bottoms of both feet turned dark brown third day (normal reactions first and second day like low fevers and fatigue)
36 2021-02-07 injection site pain Diarrhea, Nausea, Headache, Bodyache, and pain at the site of the injection. All symptoms are still ... Read more
Diarrhea, Nausea, Headache, Bodyache, and pain at the site of the injection. All symptoms are still present 4 days post injection with the exception of the pain at eh injection site.
36 2021-02-07 injection site pain PAIN ON INJECTION SITE,MUSCULAR PAIN,JOINT PAIN,PAIN ON EAR AND JAWS.
36 2021-02-07 injection site redness, injection site swelling Patient complained of mild headache and was experiencing erythema and mild edema of the left arm
36 2021-02-07 sensitive skin, injection site pain She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to tou... Read more
She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to touch. She was sensitive all over.; Chest burning and hurting; Joint pain; extremely dizzy; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; arm was sore/soreness where they gave the vaccine on her arm all the sudden came back very suddenly; The lady that gave it was not gentle. She screamed.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL1284) via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient had headaches in the past. The patient's concomitant medications were none. The patient got vaccine on the 03Jan2021 and her arm was sore, but she felt like this was normal, just like it would feel after a flu shot. Throughout the next week, she was extremely stressed for work. By Friday, which would have been 6 days later. She was feeling really off wellness wise. She was very fatigued, and extremely dizzy on 07Jan2021. On Saturday night 09Jan2021, she felt very bad. She had a sore throat, she was coughing, her chest was burning and hurting. She had severe chills and aches. She thought maybe she needed more sleep because she works out 6 days a week. She felt like she was in over drive like she was killing herself. Sunday morning 10Jan2021, she felt bad. She has so much adrenaline. She was always on the go. She decided to take a nap before the gym Sunday, and she woke up with a huge migraine. She had headaches in the past, but never a migraine. Her head was hurting so bad it woke her up. It hurt all over. She also felt like she had taken a hammer to her joints and bones. Her joints and bones were hurting. She has never felt that before. Her muscles were so achy. Her skin even hurt to touch. She was sensitive all over. She had severe chills. The soreness where they gave the vaccine on her arm all the sudden came back very suddenly. It came back the same day as the other symptoms started. They mostly started on the 09Jan2021, and then on the 10Jan2021 they were worse while migraine and bone hurting were occurred on 10Jan2021. She assumed there were subtle symptoms leading up to the 09Jan2021, but she just didn't realize it. That was a Saturday and Sunday. The lady that gave it was not gentle. She screamed. The side effects lasted at least 5 days after the 10Jan2021. On the 10Jan2021, she did not feel well so she got tested for COVID because her boss told her to. They tested her Flu, COVID, and strep. She only tested positive for COVID on 10Jan2021. She felt like she wouldn't be able to drive. She couldn't walk for 4 days. She felt most of the symptoms had gone away around 5 days after the 10th except fatigue, feeling dizzy, and headaches here and there. She also had a little coughing here and there. That started 09Jan2021 and was ongoing but improved. She got the vaccine because the doctor at her practice really encouraged her to get it done. She also thought if she ever wanted to travel that she might need it. She thought in the long run she might benefit from having the vaccine. She felt peer pressured honestly to get it because she was sketched out to get it at all. She wants to know the rate of people testing positive for COVID after getting the vaccine. The outcome of the events sore arm, chest burning, joint and bone pain, skin even hurt to touch and sensitive was recovered on 15Jan2021, the outcome of the events screamed and couldn't walk was unknown and the outcome of the other events was recovering.
36 2021-02-07 skin warm States she feels burning in lips. Ears felt flushed @ 10AM. At 10:18AM States lips improved, no lo... Read more
States she feels burning in lips. Ears felt flushed @ 10AM. At 10:18AM States lips improved, no longer tingling only ears feeling hot. nurse supervisor spoke with Dr. who request to call PCP. Pt called PCP . 10:08AM BP 162/104, HR 84. 10:18AM BP 153/110, 10:36AM BP 158/100
36 2021-02-08 hardening 5 hours after receiving my second dose of Pfizer vaccine, my left shoulder and neck was severely swo... Read more
5 hours after receiving my second dose of Pfizer vaccine, my left shoulder and neck was severely swollen. I had many swollen lymph nodes and 1 in my neck was hard as a rock. It was painful to the touch. I also had a swollen lymph node under my left armpit.
36 2021-02-09 injection site pain 1/13/21-felt feverish (T=99.0), moderate HA, moderate arthralgias, moderate fatigue, mild BA, mild i... Read more
1/13/21-felt feverish (T=99.0), moderate HA, moderate arthralgias, moderate fatigue, mild BA, mild intermittent nausea. 1/14/21-moderate right axillary lymphadenopathy, mild right arm injection site pain, mild BA, mild nausea-lymphadenopathy impacted daily activities. Treated pain with Tylenol 1G, took twice over the course of the day. 1/15/21-felt feverish (T=98.8), moderate right axillary lymphadenopathy, little impact on daily activities. Took Tylenol 1G once. 1/16/21-symptoms resolved.
36 2021-02-09 vaccination site pain Headache; neck pain; numbness into extremities; extreme pain in left arm; Extreme muscle pain in nec... Read more
Headache; neck pain; numbness into extremities; extreme pain in left arm; Extreme muscle pain in neck caused me to go to ER; Significant bilateral shoulder pain; Weakness; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 20Jan2021 16:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient is not pregnant at the time of report and at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose on 31Dec2020 on the left arm. On 20Jan2021 21:00, the patient's extreme muscle pain in neck caused her to go to the ER and tramadol and Norflex were administered. The patient had significant bilateral shoulder pain and weakness. The head and muscle pain in neck persisted. Events resulted in emergency room/department or urgent care. Treatment received were tramadol and Norflex. On 20Jan2021 22:00, the patient experienced headache, neck pain, numbness into extremities, and extreme pain in left arm. The events resulted in emergency room/department or urgent care. Tramadol was received as treatment but it worsened the symptoms. The tramadol was administered on the left arm at the hospital. Outcome of the events "extreme muscle pain in neck", "significant bilateral shoulder pain", and "weakness" was unknown and of the other events was not recovered. Information about lot/batch number has been requested.
36 2021-02-09 vaccination site pain Initially had left arm pain post vaccine. I thought that this was normal vaccine site pain. The pain... Read more
Initially had left arm pain post vaccine. I thought that this was normal vaccine site pain. The pain has subsided but I now have left arm weakness and an inability to lift arm to previous height.
36 2021-02-09 rash, injection site rash Pfizer-BioNTech COVID-19 Vaccine Anaphylaxis reaction Background -I have had one other anaphylaxi... Read more
Pfizer-BioNTech COVID-19 Vaccine Anaphylaxis reaction Background -I have had one other anaphylaxis event in my history in reaction to horse dander many years ago. As such per the guidance I remained in the waiting room for 30 minutes. After 30 minutes I had a light rash on both forearms and near the injection site on my left upper arm. I felt fine otherwise. I went up to the nurse in the monitoring room and showed her the rash. She asked if I was having trouble breathing. At the time I was not. She said I could take Benadryl for the rash as long as I had no allergy to Benadryl. I started driving home. During my drive my throat started to feel itchy and irritated. It proceeded to get worse and when I looked at my throat in the mirror it was very red and starting to be visibly swollen. I drove to the nearest hospital and checked myself in to the emergency room.
36 2021-02-09 skin irritation never had high blood pressure, she is normally 105/60, and in the ER she was 170/101; chills; fever;... Read more
never had high blood pressure, she is normally 105/60, and in the ER she was 170/101; chills; fever; skin irritation, like achiness from wearing clothes; neck is very stiff; headache; general malaise; numbness in hand and arm; muscle pain; muscle spasms; exhausted; pain; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1283), via an unspecified route of administration in the left deltoid on 20Jan2021 16:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (lot EH9899) on unspecified date for COVID-19 immunisation. On 20Jan2021 the patient had headache with outcome of recovering, general malaise, muscle pain and muscle spasms in neck with outcome of not recovered, numbness in hand and arm with outcome of unknown. On 21Jan2021 the patient experienced chills with outcome of recovered in Jan2021 and fever with outcome of recovered on 21Jan2021, neck was very stiff, skin irritation, like achiness from wearing clothes with outcome of unknown. The patient experienced also exhausted, pain, on Jan2021 with outcome of unknown and high blood pressure (she was normally 105/60, and in the ER she was 170/101) on 23Jan2021 with outcome of unknown. Clinical course was as follows. The patient began to develop the following symptoms: headache, numbness in hand and arm, and muscle spasm in neck. The patient was working and had some patients the day following vaccination, and her headache got much worse, the muscle spasms and pain were worse, and all of a sudden she got skin irritation, like achiness from wearing clothes, and she realized she had a bit of a fever. Chills have gone away, she did not feel those. Muscle aches, especially the muscle spasms on her neck into the shoulder have not. Fever went away that day, she took Tylenol, and after she took it, she got home from work, and was better that evening from chills and fever, she has recovered completely from fever. She was in so much pain, she was feeling overall exhausted. She had headaches the day of the injection. She thought she had slept wrong, possibly the night before, so she didn't think of it, until symptoms worsened. She went to emergency room on 23Jan2021 due to severity of the muscle spasms in neck, so the doctor was worried about stenosis, or like impingement of spinal cord, but the CT scan on 23Jan2021 was negative for structural reasons, so she was prescribed a muscle relaxer and one for pain and inflammation. The patient was given Tramadol and Norophlex at the ER via injection in each arm. After receiving injections she reported that she developed a severe reaction in both arms, she cannot move her arms, it was extremely painful, like she had surgery on both sides and her neck was very stiff. Her arms were now weak, very painful, and she could not lift her arms. She has had Tramadol in the past, never had pain, but this was worse than labor. Her left arm felt like it would explode when he injected it, and now she can barely move both arms, she has not been able to move her arms, and the hospital doesn't know why, this is not a response from those medications. Headaches were the same intensity, but better from when she went to the ER. They were now a 7 out of 10 and in the ER were a 10 out of 10. When she got chills, she had an intense stiffness in her neck, muscle pain across shoulders to upper back, and it varies in intensity, she's been laying down the last day and a half, today was tolerable, but when she went to the ER on Saturday, it was so extreme she thought she had a nervous breakdown, it was a lot of pain, she didn't know if that contributed to her elevated blood pressure, or was something separate.
36 2021-02-10 rash, itchy skin, injection site pain 1/6/21 - left underarm soreness, 1/7/21 - body aches, fatigue, headache, felt cold, took ibuprofen a... Read more
1/6/21 - left underarm soreness, 1/7/21 - body aches, fatigue, headache, felt cold, took ibuprofen and felt better, fever started, 1/8/21 - fever, malaise, body aches, rash started on arms and worsened until it covered entire body surface head to toe, went to urgent care for testing, flu and COVID negative, fever came down and tachycardia persisted when afebrile (160's finally coming down to 130ish when lying down deep breathing), urgent care physician wanted an EKG due to tachycardia, drinking plenty of water, not dehydrated, 1/9/21 - fever and entire body rash persisted, taking acetaminophen, ibuprofen, and diphenhydramine, 1/10 - rash improved and intense itching started, had to take 75mg diphenhydramine every 3 hours and stay in the bathtub to tolerate itching, still had fever on and off but was responsive to medication, 1/11/21 - intense itching continued, same therapy as previous day, 1/12/21 - itching improved, no fever, 1/13/21 - able to work remotely, 1/14/21 - able to work on site.
36 2021-02-10 rash, itchy skin 2/5/21- Received 2nd dose of COVID-19 vaccine 2/8/21- elbows and arms began to itch in the afternoon... Read more
2/5/21- Received 2nd dose of COVID-19 vaccine 2/8/21- elbows and arms began to itch in the afternoon. By the evening, legs and back were itchy too. 2/9/21- body from the neck down was itchy and covered in a red rash. Visited care clinic and received a prescription for Triamcinolone Acetonide Ointment 0.025% 2/10/21- woke up with swollen face and lips. swelling subsided within an hour of waking. Whole body still covered in rash and very itchy. was unable to complete a full day of work due to discomfort. 2/11/21- still covered in a full body rash and itchy with minor improvement.
36 2021-02-10 itchy skin, rash papular, vaccination site pain, vaccination site itchiness Right arm was very sore; right hand felt numb; itchy on the right side of her back and her right arm... Read more
Right arm was very sore; right hand felt numb; itchy on the right side of her back and her right arm; Itchy on the right side of my back; Rash with bumps; This is a spontaneous report from a contactable healthcare professional (patient). This 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 22Jan2021 15:00 at a single dose on the right arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included unspecified birth control pill. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On day 2, 23Jan2021 17:00, the patient's right arm was very sore, right hand felt numb, itchy on the right side of her back and her right arm. The patient started to develop rash with bumps. Rash went away as soon as she took Benadryl. On Day 3, she was back to normal, no soreness, no numbness and no itchiness. The events were reported as non-serious. Outcome of the events was recovered on 24Jan2021.
36 2021-02-14 itchy skin, redness 1335 at the end of her 15 min wait pt states that her neck is itching. A few red marks noted on her... Read more
1335 at the end of her 15 min wait pt states that her neck is itching. A few red marks noted on her neck. Pt states that her sx started about 5' after receiving her vaccine. Pt escorted to observation area. Vitals 130/88, O2 98, HR 81. Pt states that she has known mast cell activation syndrome and sees Doctor. Pt states that she has had reactions like this, treats with Benadryl dosing per allergist. Pt. states that she has never used an Epi-pen. Pt denies throat swelling. Pt is clearing her throat but states that she is getting over sinus infection and this is the same as she has been. Pt called answering service for allergist and is awaiting a return call from her allergist. Pt. states that she prefers to go home and get Benadryl vs. waiting in the clinic longer. Pt. states that her fiancé is a firefighter and she is comfortable leaving with him, since he drove. 1345 BP 130/88, O2 98%, HR 81, Pt escorted to car and left at 1352
36 2021-02-14 hives Within minutes of taking the Pfizer vaccine I broke out in hives. My lips started tingling and slig... Read more
Within minutes of taking the Pfizer vaccine I broke out in hives. My lips started tingling and slightly swelling. I waited for 30 mins and EMT said it was safe for me to leave because it wasn't causing breathing issues. I took Benadryl when I got home and hives lasted 24 hours.
36 2021-02-15 injection site pruritus, injection site hardening, injection site warmth, injection site swelling The next day, the injection site was hot to the touch, swollen, itchy, and hard. It went away after ... Read more
The next day, the injection site was hot to the touch, swollen, itchy, and hard. It went away after another day or two, but now it is back (11 days later). It is not as swollen but it is itchy, warm, and hard.
36 2021-02-16 dry skin Delayed menstruation for 7 days Skin dryness on exterior of hand on same side of injection
36 2021-02-16 injection site swelling, injection site bruising, injection site redness, injection site pain Fever, dizziness, headache, body aches, joint pain, fatigue. Began Friday 2/12/21 Sxs lasted 2 days ... Read more
Fever, dizziness, headache, body aches, joint pain, fatigue. Began Friday 2/12/21 Sxs lasted 2 days Redness, swelling, bruising, pain at injection site. Started day of 2nd Covid vaccine 2/11/21. Still having pain and also have a bruising at injection site.
36 2021-02-18 rash Allergic reaction post vaccine; rash and hives to bilateral legs, back, and face. Client complained ... Read more
Allergic reaction post vaccine; rash and hives to bilateral legs, back, and face. Client complained of mild shortness of breath.
36 2021-02-21 injection site pain 15 hours after injection I experienced severe joint pain all over my body. This continued until 32 h... Read more
15 hours after injection I experienced severe joint pain all over my body. This continued until 32 hours post vaccine. Motrin and Tylenol helped but didn?t completely take all pain away. Injection arm was slightly sore. I was lethargic until 36 hours post vaccine. All symptoms subsided the next morning.
36 2021-02-21 injection site redness, injection site hardening, injection site warmth, injection site bruising Body aches, chills, mild fever, extreme muscle soreness. Fatigued. Injection spot bruised with larg... Read more
Body aches, chills, mild fever, extreme muscle soreness. Fatigued. Injection spot bruised with large red, hard and very sensitive to touch circle around it about 1.5-2 inches wide that is hot to touch. Has been there now for almost 4 days with no signs of easing up yet.
36 2021-02-21 injection site hives, injection site pruritus, injection site hardening, injection site redness I have a large lump (axillary area) in the armpit of my left arm which is the injection arm. I noti... Read more
I have a large lump (axillary area) in the armpit of my left arm which is the injection arm. I noticed it roughly two days after the 2nd injection. It was non painful at first, but now it is tender. It is roughly the size of an egg/golf ball. I also have tenderness on my chest above my right breast but on the pectoralis muscle. Nothing in the right armpit. I also had aggressive itching at the injection site and a hard area and red welt.
36 2021-02-21 itchy skin, redness after receiving the vaccine, I have developed a skin intolerance to heat (hot water, hit items touch... Read more
after receiving the vaccine, I have developed a skin intolerance to heat (hot water, hit items touching skin), heat causes itching and tingling and well as redness and swelling with hotter temperatures at longer durations. This has been occurring since after receiving the first vaccine, with increased severity after the second. The symptoms last from 20-2 hours after exposure and then resolve.
36 2021-02-21 injection site rash, rash, itchy skin started out with a rash around injection site and is now full blown on left arm from top to wrist an... Read more
started out with a rash around injection site and is now full blown on left arm from top to wrist and under to arm pit area of arm. rash is a burning sensation and very itchy.
36 2021-02-22 bruising Chills, body aches, lymph node swelling, headache, severe fatigue, purple bruise, swallowing issue
36 2021-02-22 injection site redness Pain to left axilla with swelling, redness to inject site one week later, general fatigue x 1 week.
36 2021-02-23 redness 12 hours after redness and heat on hand and elbow on the left side; 12 hours after redness and heat ... Read more
12 hours after redness and heat on hand and elbow on the left side; 12 hours after redness and heat on hand and elbow on the left side; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 26Jan2021 at 07:30 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included caffeine/paracetamol (EXCEDRIN), paracetamol (TYLENOL) and ergocalciferol (VIT D). Past drug history included known allergies: cefaclor (CECLOR) and sulfamethoxazole/trimethoprim (SEPTRA). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Jan2021 at 19:30, 12 hours after vaccination, the patient experienced redness and heat on hand and elbow on the left side. Treatment included applied Burts Bees lotion on hand and elbow for the event redness and heat. The outcome of the event redness and heat was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
36 2021-02-23 itchy skin, hives, rash Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched ... Read more
Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched and burned on my head; Rash to my face; Body aches; weakness; fatigue and woozy feeling xs 4 days; fatigue and woozy feeling xs 4 days; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 20Jan2021 23:15 at a single dose for COVID-19 immunization. Medical history included Raynaud's, hypotension, known allergies: barley, oatmeal, pork, tomatoes. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took doxycycline and experienced allergies. Benadryl prior to administration. On 20Jan2021 03:00 PM, the patient experienced hives that itched and burned on her head - still remain after 6 days but improved. Rash to her face, body aches, weakness, fatigue and woozy feeling for 4 days. Events treatment included diphenhydramine (BENADRYL). The facility where the vaccine was administered was in a nursing home/senior living facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID test post vaccination included Nasal Swab (Rapid and PCR) on 21Jan2021: negative. Outcome of the events was recovering.
36 2021-02-23 injection site pain I woke up with a moderate headache at 7am. My entire body began to ache by 10am. Full body chills be... Read more
I woke up with a moderate headache at 7am. My entire body began to ache by 10am. Full body chills began at noon. I was lethargic with full body aches, headache and chills for the remainder of the day. I checked my temperature throughout the day, but I never had a fever. My symptoms prevented me from working that day, but I did not take pain medication and I was able to eat meals normally. At some point during the night, I woke up in a sweat. The following morning, Feb 12th, the symptoms were gone. The injection site was sore for a few days more.
36 2021-02-23 itchy skin, rash with redness, rash Rash all over neck and shoulders. Under breast and armpits. Red and painful. Itchy. Treated with ste... Read more
Rash all over neck and shoulders. Under breast and armpits. Red and painful. Itchy. Treated with steroid shot and steroid given to take orally for 1 week
36 2021-02-23 skin burning sensation Shoulder blade pain with sharp pain that feels like it is on fire. Hurts to do daily activities (i.e... Read more
Shoulder blade pain with sharp pain that feels like it is on fire. Hurts to do daily activities (i.e. carry cup, extend arm, lift anything). Have tried Ibuprofen 800 mg, heat patch, and heating pad with no improvement. Ongoing all day since 2.14.21
36 2021-02-24 rash, rash with redness, itchy rash I initially developed an erythematous, pruritic rash on the posterior neck, trunk, arms and distal l... Read more
I initially developed an erythematous, pruritic rash on the posterior neck, trunk, arms and distal legs. In the next 24 hours the rash improved on the trunk but became more severe on the extensor surfaces of the arms (mostly near the elbows), knees and shins, with a few lesions on the anterior trunk. The rash is pruritic and pruritus is minimally improved with Benadryl. The pruritus and erythema is most improved with NSAIDs or Prednisone. The rash has continued for 5 days (still present), the lesions have lightened and pruritus is controlled with the use of daily Prednisone and PRN Ibuprofen 600-800mg but it is still present on the knees, shins and elbows. The appearance seems to be consistent with erythema nodosum, which I have not previously had. I have no prior history of allergic reactions to vaccines or history of delayed hypersensitivity reactions.
36 2021-02-24 hives hives , onset 4 hours post injection. Pt took benedryl 50 mg and hives resolved without recurrence
36 2021-02-25 injection site discomfort 12w 1d pregnant, The first day I had nausea, fatigue, injection site discomfort, metallic taste in m... Read more
12w 1d pregnant, The first day I had nausea, fatigue, injection site discomfort, metallic taste in my mouth. The second day (today), I had nausea, fatigue and diarrhea.
36 2021-02-25 rash Rash beginning from first dose, increasing after second. Covering torso area. Some nausea day 2 afte... Read more
Rash beginning from first dose, increasing after second. Covering torso area. Some nausea day 2 after dose 2
36 2021-02-26 shingles Severe headache started 2 weeks after the vaccine and third week shingles in v1 distribution over th... Read more
Severe headache started 2 weeks after the vaccine and third week shingles in v1 distribution over the forehead followed by prodromal uri symptoms. Treated with valtrex 1g tid x 10days. Rash resolved, headaches improved with Tylenol. Vague abdominal and joint pains that resolved spontaneously.
36 2021-02-28 injection site reaction, itchy rash, rash with redness 1/8 vaccination Within 24 hours, I started having a minor red rash on upper arm. It became progress... Read more
1/8 vaccination Within 24 hours, I started having a minor red rash on upper arm. It became progressively over all extremities, minus face. Itchy, red rash. I went to the doctor on Monday. She wasn't sure if related to vaccine. Symptom mgt. Antihistamines. She prescribed Singular to help with the itchiness and monitoring. It lasted for 7 days after vaccine.
36 2021-02-28 rash Covid vaccine-Pfizer. Administered on 2/20/21. Swollen arm, fever, aches, chills, sweats, rash, whee... Read more
Covid vaccine-Pfizer. Administered on 2/20/21. Swollen arm, fever, aches, chills, sweats, rash, wheezing, lasting 5 days
36 2021-02-28 redness Fever, stomach cramps, migraine, chills, nausea, vomitting, diarrhea, fatigue, muscle ache, arm pain... Read more
Fever, stomach cramps, migraine, chills, nausea, vomitting, diarrhea, fatigue, muscle ache, arm pain/redness/numbness
36 2021-02-28 rash macular, injection site redness Injection site it red and blotchy. Area is currently non-itchy . Appeared 10 days after injection.... Read more
Injection site it red and blotchy. Area is currently non-itchy . Appeared 10 days after injection. SIte it about an inch long, 1/2 in wide in one area, about 1/3 inch around below.
36 2021-03-01 injection site pain By 3pm I was extremely lethargic. By 7pm I was starting to feel a bit "not myself" and had an optic ... Read more
By 3pm I was extremely lethargic. By 7pm I was starting to feel a bit "not myself" and had an optic migraine and by 10pm I was throwing up and had chills (no fever) and aches on all limbs. The vomiting and chills went away by 12am but the aches lasted all through the next day. The left arm/injection site also ached the rest of the week.
36 2021-03-01 rash, skin reaction, pain of skin, itchy skin, skin peeling, dry skin, redness Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larg... Read more
Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; edge is now scaly and dry; edge is now scaly and dry; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 21Jan2021 (Lot number: El3249) via an unspecified route of administration in the right arm at single doe for COVID-19 immunization. The patient had no medical condition. The patient had no allergies to medications, food, or other products. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 08:00 AM (Lot number: EJ1685) via an unspecified route of administration in the left arm for COVID-19 immunization and at 31Dec2020 12:00 PM experienced small rash on left side of chest. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient concomitant medication included Levothyroxine sodium (Euthyrox, Strength: 150ug) and Drospirenone/ethinylestradiol (Nikki, Strength: 3mg/0.02mg). After first shot developed small rash on left side of chest. Persisted for three weeks and was starting to fade when she got second dose. Grew 4-5 times larger, raised, painful, red itched and tender. Now reaches my neck and breasts and shoulders. White normal skin in center, edge was now scaly and dry, itches very badly. Dr won't prescribe steroid fears it will dampen immune response. Taking Allegra, Benadryl and hydrocortisone cream. Does not help. Never had a reaction to a vaccine before. The patient was underwent COVID-19 (Nasal Swab) and PCR at pharmacy (nasal swab) test (test twice weekly for work) both on 29Jan2021 which were negative. The events were assessed as non-serious by the reporter. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
36 2021-03-01 injection site warmth, injection site bruising, injection site redness No reaction with first shot-2nd shot arm bruised and had a large red/warm area-noticed day of inject... Read more
No reaction with first shot-2nd shot arm bruised and had a large red/warm area-noticed day of injection has progressively gotten biger
36 2021-03-01 hives Patient describes "ridges" on tongue and Hives to chest
36 2021-03-01 rash Patient received her vaccine, 20 minutes later reported a rash forming on her chest, and mild chest ... Read more
Patient received her vaccine, 20 minutes later reported a rash forming on her chest, and mild chest tightness. She has a history of Mast Cell Activation Syndrome, and had pre-medicated with Zyrtec. At 1420 the nurse administered 25mg PO Benadryl. at 1450, she felt her symptoms and decreased, and went home with her spouse.
36 2021-03-01 rash with redness, itchy rash Within 15-minutes of vaccination, the patient reported a pruritic, erythematous rash to their bilate... Read more
Within 15-minutes of vaccination, the patient reported a pruritic, erythematous rash to their bilateral hands and legs. EMS evaluated patient on-site. EMS administered 25mg IV Benadryl and transported the patient to the Emergency Department. In the ED, the patient reported that their throat felt tight, but that the pruritus has improved. No labs were ordered. The patient was discharged with an allergic reaction and prescribed Benadryl 25mg PO and Prednisone 20mg PO dose pack.
36 2021-03-02 hives Hives on thighs, arms and stomach; This is a spontaneous report from a contactable consumer. The con... Read more
Hives on thighs, arms and stomach; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 36-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: EL9266), via an unspecified route of administration on 19Feb2021 18:00 on Right arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: EL9269) , via an unspecified route of administration on 29Jan2021 08.30 AM on Right arm at single dose for covid-19 immunization. The patient experienced hives on thighs, arms and stomach on 19Feb2021 19:30 with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered at School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Hives on thighs, arms and stomach within 45 minutes of injection. Hives subsided within a few hours. No treatment was received for the adverse event. The event was assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products.
36 2021-03-03 injection site pruritus, itchy skin I initially had itchiness at injection site, then more of my arm. At 15 minutes I talked with the nu... Read more
I initially had itchiness at injection site, then more of my arm. At 15 minutes I talked with the nurse, she looked at and we talked for quite a bit what I should do but I was feeling just fine and left to go home and take benedryl. I had just left the hospital (25 mins post shot) and my throat and tongue started swell rapidly. I called 911 and the county rescue responded. My breathing was normal by then. My body has been itchy all over since then and my throat remains minor swollen. I did not get an epi shot since I was mostly okay and the EMTs were convinced I had a panic attack so I just went home.
36 2021-03-03 itchy skin, rash My symptom began with an itchy spot on my left forearm advancing to the back of my neck and head fol... Read more
My symptom began with an itchy spot on my left forearm advancing to the back of my neck and head followed by a rash. The rash extended over my neck, chest, face, spreading to entire body. The left side of my lip also had swollen and became tingly. All symptoms started roughly at 3am on 3/4/21. I took ibuprofen 800mg along with Benadryl 25mg. At 0730am rash had dissipated some and most of the itching subsided, another Benadryl 25mg tablet was taken. At 1030am, rash had dissipated except still remaining on both elbow areas, non itching at this point. At 1230, another Benadryl was taken.
36 2021-03-03 itchy skin, rash Severe Full body rash and extreme itching, had to have a steroid shot and take 5 days of oral steroi... Read more
Severe Full body rash and extreme itching, had to have a steroid shot and take 5 days of oral steroids.
36 2021-03-03 redness, skin warm, rash macular, itchy skin Was released from the testing site 5-10 minutes after second dose was administered. Approximately 15... Read more
Was released from the testing site 5-10 minutes after second dose was administered. Approximately 15-20 minutes after dose was administered I began feeling a reaction. The skin on my face, neck, and chest became red, flushed, warm, splotchy, and itchy. My tongue and throat began to feel swollen/tight. I was also lightheaded and dizzy. My husband was driving the car and we almost returned to the vaccination site, but after approximately 5 more minutes, the tightness in my throat subsided, so we continued to go home. The flushing and lightheaded-ness went away after approximately 20 minutes. This is similar to the reactions I had just before I discontinued taking copaxone (approx. 2 years ago). I did not feel this way after dose one of the Pfizer COVID vaccine.
36 2021-03-04 injection site swelling 2 days after the injection, my left arm, hand, and fingers swelled significantly. This continued for... Read more
2 days after the injection, my left arm, hand, and fingers swelled significantly. This continued for another 5-6 days. It became so bad that I had to have my wedding band and engagement ring cut off my fingers because it was cutting off my circulation. I also had a lump under my left armpit
36 2021-03-04 shingles, rash vesicular, itchy skin, rash with redness I had my first COVID vaccine on 1/16/21. I had my second one on 2/5/21. On 2/9/21 I started experien... Read more
I had my first COVID vaccine on 1/16/21. I had my second one on 2/5/21. On 2/9/21 I started experiencing a sharp pain in my left breast. On 2/10/21 I had sharp pain in between my shoulder blades. On 2/11/21 I noticed a small red rash-like spot in between my breast. I woke up on 2/12/21 in incredible pain on my back, so I lifted my shirt to look in the mirror and that is when I noticed a blister type rash from the middle of my back wrapping around the front of my body covering my left breast. I went to see the PA at my PCP's office. She diagnosed me with shingles. She placed me on an anti-viral medication for a week, and gabapentin (nerve medication) for a month. It has been 3 weeks today since I first began treatment and I have not fully recovered yet. My blisters dried up about a week ago, but ever since then I have been incredibly itchy, which has kept me up every night for over a week now. On 3/3/21 I called my PCP's office and they started me on Prednisone for 6 days. I am 2 days into treatment and I still have not had relief from the itching.
36 2021-03-04 rash No issue with first vaccination on 12/30/20. 2nd vaccine on 1/21/21. Started with a single "spot" o... Read more
No issue with first vaccination on 12/30/20. 2nd vaccine on 1/21/21. Started with a single "spot" on abdomen on 2/1/21, has increased to now cover skin from neck to upper thighs. Went to PCP and instructed to take current anti-histamine PO and to get OTC steroid (Cortisol 1%) cream with no relief to date. Did not follow up until 3/2/21 because thought it would go away. Rash stable X7 days. Diagnosed with pityriasis rosea. Derm appointment on 3/15/21.
36 2021-03-04 redness PT BEING MONITORED FOR 30 MINUTES. AT 0930 PRIOR TO LEAVING. 0931: PT STATED THAT HER THROAT FELT SC... Read more
PT BEING MONITORED FOR 30 MINUTES. AT 0930 PRIOR TO LEAVING. 0931: PT STATED THAT HER THROAT FELT SCRATCHY AND HER CHEST FELT FUNNY. PT AIRWAY ASSESSED. ERYTHEMA TO THROAT AND UVULA NOTED, NO EDEMA OR SWELLING NOTED AT THIS TIME. PT BROUGH BACK TO OBSERVATION FOR FURTHER ASSESSMENT, BY WRITER, PHYSICIAN AND EMT. PT PLACED ON CARDIAC MONITOR- NORMAL SINUS RHYTHM. PT DENIES ANY CHEST PAIN, PALPITATIONS, PRESSURE, SOB, N/V/D NOTED. MD RECOMMENED PT GO TO ER FOR FURTHER EVALUATION PT REFUSED, BUT AGGREED TO STAY FOR TREATMENT OF IV BENADRYL AND IV DEXAMETHASONE. BOTH ADMINISTERED BT EMT AT 0958. PT TOLERATED WELL. PT CONTINUED TO BE MONITORED UNTIL S/S OF REACTION SUBSDED AT 10:20AM. PT STATES THAT THERE IS NO LONGER A SCRATCH FEELING IN THROAT AND HER CHEST FELT MUCH BETTER. VSS REMAIN STABLE. PT STILL REFUSES TO GO TO ER PRIOR TO LEAVING FACILIT. PT AMBULATED OFF SITE. ACCOMPANIED BY FAMILY.
36 2021-03-04 redness, hives Slight tickling in the back of throat, clearing throat and small hive on left forearm, redness of sk... Read more
Slight tickling in the back of throat, clearing throat and small hive on left forearm, redness of skin. Administered Zyrtec and resolved within 20 minutes.
36 2021-03-04 itchy skin Systemic: Allergic: Itch (specify: facial area, extremities)-Mild. Systemic: Allergic: Itch Generali... Read more
Systemic: Allergic: Itch (specify: facial area, extremities)-Mild. Systemic: Allergic: Itch Generalized-Mild. Systemic: Chest Tightness/Heaviness/Pain-Medium. Systemic: Tingling (specify: facial area, extremities)-Medium.
36 2021-03-05 rash, hives, rash with redness, itchy skin Night of shot I had severe arm pain and itchy skin. Next night I broke out in hives. Since vaccine I... Read more
Night of shot I had severe arm pain and itchy skin. Next night I broke out in hives. Since vaccine I?ve non stop itchy skin and hives that come and go. Mostly large rash on chest that looks like a sunburn/scratched skin. Very painful . Was told to take Zyrtec. No relief yet
36 2021-03-06 hives 6 minutes post vaccine the patient indicated that she felt her throat closing. Paramedic observed vi... Read more
6 minutes post vaccine the patient indicated that she felt her throat closing. Paramedic observed visible hives on chest and stridorous air bilateral wheezing lung sounds. Paramedic administered 0.3 mg Epinepherine and 50 mg Benadryl IM in right deltoid and conducted cardiac monitoring. Patient was transported to Hospital via ambulance.
36 2021-03-06 hives, rash hives/rash across various body parts, including behind the knees/elbows, on the neck/arms/thigh/butt... Read more
hives/rash across various body parts, including behind the knees/elbows, on the neck/arms/thigh/buttock (since 2/12/2021, ongoing); swollen lips, tingling lower jaw (since 2/12/2021, for 2 weeks); body ache (since 1/27/2021 for one week); chills and headache (since 2/17/2021, ongoing).
36 2021-03-07 rash Mouth and tongue tingle tongue numb rash on face.
36 2021-03-07 vaccination site redness Redness at injection site on day 2; This is a spontaneous report from a contactable consumer (patien... Read more
Redness at injection site on day 2; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN2600) on left arm, via an unspecified route of administration on 18Feb2021 15:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced redness at injection site on day 2 on 20Feb2021 13:30. There was no treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The event was reported as non-serious. The outcome of the event was not recovered.
36 2021-03-07 rash with redness, skin warm Subjective Patient is a 36 y.o. female who was seen today for her first dose of the COVID 19 vaccin... Read more
Subjective Patient is a 36 y.o. female who was seen today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience warmth of left arm and chest. Red rash present on left forearm. Later she developed tingling of left arm. She denied difficulty breathing, difficulty swallowing, lightheadedness and dizziness. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, chest tightness, shortness of breath, wheezing, dizziness and headaches Warmth of left arm with tingling: Previous Reactions: Flu shot made her really sick in the past with respiratory issues. She has had a tetanus shot in the last 3 years though and she handled it well without any symptoms. Objective Vitals Vitals: 03/05/21 1202 03/05/21 1238 03/05/21 1305 BP: (!) 139/100 (!) 134/112 126/86 Pulse: 80 92 SpO2: 99% 99% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Radial pulses are 2+ on the right side and 2+ on the left side. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Musculoskeletal: Comments: Equal hand grip in bilateral arms. No weakness noted. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: Rash (lower arm and near injection site) present. No erythema. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: antihistamines, water and pepcid and Tylenol. Applied ice to left arm near injection site where warmth was noted. Redness of lower and upper arm resolved with time. Follow up response to treatment: good. Symptoms resolved upon discharge and BP improved. She still had some warmth of right arm after being observed for 1.5 hours. She did not have any rashes, swelling, burning or weakness of left arm. Discussed with patient continuing to ice left arm near injection site. If she experiences any redness, swelling, burning or worsening symptoms this weekend she is to seek medical care. Pt understands and agreed to plan. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) 3/5/2021 1:05 PM
36 2021-03-08 injection site pain, itchy skin A few hours after receiving the vaccine I started to feel fatigue and started getting shooting pains... Read more
A few hours after receiving the vaccine I started to feel fatigue and started getting shooting pains through my back, injection site was slightly sore. Second day my whole body felt stiff. Third day I started getting shortness of breath. Fourth day I woke up with swollen itchy eyes and ears as well as a sore throat. It started to become even harder to breath. I took allergy medicine, Allegra and zertex and felt some immediate relief.
36 2021-03-08 skin warm Face got very hot, then mild numbness throughout cheeks, in eyes, tongue, and throat.
36 2021-03-08 itchy skin, shingles I have been diagnosed with shingles as of yesterday, March 8, 2021. Symptoms started last Wednesday,... Read more
I have been diagnosed with shingles as of yesterday, March 8, 2021. Symptoms started last Wednesday, March 3, 2021: feeling of pulled back, itching underneath left breast and left side by bra line. Itching continued through the weekend and small sores developed. I treated with hydrocortisone cream @ 1% and and neosporin for 3 days. I called my primary care physician and his colleague diagnosed with jock itch. A few hours later I called my OBGYN and after looking at pictures I submitted to her office, she diagnosed me with shingles. I am now on Valtrex 3 times a day.
36 2021-03-08 injection site warmth, injection site pruritus, injection site hardening, injection site redness, bruising Injection site became red, itchy, firm, and hot a week after vaccine. This lasted 2-3 days then turn... Read more
Injection site became red, itchy, firm, and hot a week after vaccine. This lasted 2-3 days then turned into what looks like a bruise without pain. Faint bruising still there two weeks later.
36 2021-03-08 rash Reaction: tingling in fingers of vaccine arm and small local rash on forearm Outcomes: Benadryl 25 ... Read more
Reaction: tingling in fingers of vaccine arm and small local rash on forearm Outcomes: Benadryl 25 mg given at 17:10. Rash resolved and tingling subsided.
36 2021-03-10 itchy skin, rash macular Became very ill once vaccine was completed, became hot, pounding headache, skin itchy and red splotc... Read more
Became very ill once vaccine was completed, became hot, pounding headache, skin itchy and red splotches , blood pressure was elevated and throat started getting tight
36 2021-03-11 itchy rash, rash Rash and itching of legs and back, began approximately 4.5 hrs after injection; took a Benadryl, sti... Read more
Rash and itching of legs and back, began approximately 4.5 hrs after injection; took a Benadryl, still mild itching
36 2021-03-12 injection site swelling, injection site pruritus, injection site pain Abdominal pain, nausea, fever, seeking at injection site, pain at injection site, itching at injecti... Read more
Abdominal pain, nausea, fever, seeking at injection site, pain at injection site, itching at injection site, swelling at injection site, sweating, flushing, fatigue, malaise
36 2021-03-12 rash Rash on forehead.
36 2021-03-12 skin spots Received first dose of the Pfizer vaccination at 09:35am, about 15 mins later I began to develop pet... Read more
Received first dose of the Pfizer vaccination at 09:35am, about 15 mins later I began to develop petechiae to both my arms and abdomen. I had the nurses look at my petechiae that had developed, then had me sit for another 15 mins. During that time, I began to develop heart palpitations and chest discomfort. They had me sit in another room and evaluated me. My blood pressure was high in the 140's systolic, which is abnormal for me, I?m usually 110 systolic. I began to have some shortness of breath; I wasn't able to take a deep breath. I was taken to the ED to be evaluated for my symptoms. There I was asked a series of questions, they had taken an EKG and my blood pressure was 151 systolic, then was taken to a triage room. MD ran a series of blood work and was given SOLU-Medrol IV push for my allergic reaction and Shortness of breath. I was kept in the ED for about 4 hours. Labs came back normal and was prescribed 20 mg Prednisone by mouth and 25mg Benadryl by mouth to take at home. My diagnose was Allergic reaction, Initial encounter. I was to follow up with my PCP. Followed up with my PCP the following day, 3/12/21 and she had run a CMP and CBC, looked at my petechia and referring me to Oncologist/hematologist to further evaluated for my platelet count and petechiae. She wants to make sure I won't be developing ITP.
36 2021-03-12 hives Severe generalized hives everyday since 2/18. Have had to see allergist and dermatologist.
36 2021-03-13 skin irritation, redness, injection site pain, itchy skin Within 5 minutes of receiving the vaccine, I experienced extreme dizziness. This dizziness lasted fo... Read more
Within 5 minutes of receiving the vaccine, I experienced extreme dizziness. This dizziness lasted for 2 days. The following day I felt extreme fatigue, body aches and arm soreness at the injection site in addition to the dizziness. Exactly 7 days later on 3/13/21 (after my initial side effects had resolved), my left arm began to itch painfully and intensely. The itch began on my left wrist and by the end of the day, the itchy spot on my wrist had progressed to itchiness on the majority of my left arm. It's not very visibly red, but it's incredibly itchy and painful, like fiberglass under my skin. The itch is not obviously localized to the injection site but is on the same arm as the injection and nowhere else on my body. It has lasted for 24 hours, and I currently still have it today (3/14/21). I have taken antihistamines and NSAIDs and applied cortisone cream, but it is still very, very uncomfortable. It kept waking me up while I slept during the night. I am wondering if this could be "COVID arm."
36 2021-03-14 sensitive skin Gums hurting and randomly starting bleeding without being touched. Gums very sensitive. I also fee... Read more
Gums hurting and randomly starting bleeding without being touched. Gums very sensitive. I also feel extremely tired since day of Injection. It is now two days later. My mouth feels strange like I?m clenching my jaw. Perhaps feeling more sensitive to the physical effects of caffeine after only 1 small cup of coffee.
36 2021-03-14 redness Pain, redness, swelling
36 2021-03-14 rash, hives Patient with anaphylaxis to COVID-19 vaccine. Onset of symptoms occurred five minutes after receivi... Read more
Patient with anaphylaxis to COVID-19 vaccine. Onset of symptoms occurred five minutes after receiving vaccine. Urticarial rash occurred on chest and abdomen. Shortly after, she developed a wheeze. EMS was onsite so they administered methylprednisolone, diphenhydramine, Zofran, Phenergran and epinephrine IM. Second and third dose of epinephrine was administered due to partial response from previous doses. Patient was taken to Health care hospital for further evaluation and treatment.
36 2021-03-14 itchy rash, skin warm, injection site swelling, injection site rash, redness Red, itchy rash spread from the just above the injection site and below the injection site. Approxim... Read more
Red, itchy rash spread from the just above the injection site and below the injection site. Approximately 6 inches long and 3 inches wide. Area is hot and slightly swollen to touch but does not actively hurt or is sore. Developed 24 hours after 2nd dose of vaccine along with chills, low fever and body aches. Those resolved in 24 hours but the red, itchy rash is still active 72 hours after shot.
36 2021-03-14 injection site pain Vaccine was on a Friday...6 hours after injection I started vomiting and having diarehha at the same... Read more
Vaccine was on a Friday...6 hours after injection I started vomiting and having diarehha at the same time, severe localized pain in my left thigh that lasted about 24 hours. Severe Fatigue and muscle aches continued throughout the next 48 hours. 48 hours after I started with the headaches and weakness in arms. Headaches have been persistent since my 1st dose and now I am taking medication to help prevent the headaches. I couldn't work Monday. Exactly 3 weeks later, when I was due to have my 2nd vaccine, I woke up at 3 am with a severe headache and nausea and the achiness and fatigue started. This lasted 24 hours and then went away. I had to miss that day of work. Had the 2nd vaccine a week later (and was VERY nervous) but had mild symptoms. I had pain in the left arm where the injection was and some mild fatigue and achiness. Had no other illnesses between this time and am convinced the episode that happened 3 weeks later was some sort of delayed immune response because I felt pretty similar as I did the first time.
36 2021-03-14 rash small rash on left side of chest; This is a spontaneous report from other Health Professional (repor... Read more
small rash on left side of chest; This is a spontaneous report from other Health Professional (reported for herself). A 36-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EJ1685), on arm left via an unspecified route of administration on 31Dec2020 08:00 at single dose for covid-19 immunisation . Medical history included none. Concomitant medication included levothyroxine sodium (EUTHYROX, strength: 150mcg), drospirenone, ethinylestradiol (NIKKI, strength: 3mg/0.02mg). It was reported that after first shot (31Dec2020) developed small rash on left side of chest. Persisted for three weeks and was starting to fade when patient got second dose. Grew 4-5 times larger, raised, painful, red itched and tender. Now reaches my neck and breasts and shoulders. White normal skin in center, edge is now scaly and dry, itches very badly. Dr won't prescribe steroid fears it will dampen immune response. Taking Allegra, Benadryl and hydrocortisone cream did not help. Never had a reaction to a vaccine before. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. Post vaccination Covid test done on 29Jan2021, Covid test type post vaccination was nasal Swab, covid test result was negative. Outcome of the event was not recovered.
36 2021-03-15 hives Few hives (both eyes) starting at 7PM on 3/15/21. Took benadryl right away. Swollen and dry eyes (bo... Read more
Few hives (both eyes) starting at 7PM on 3/15/21. Took benadryl right away. Swollen and dry eyes (both eyes), also felt burning, when woke up at 8AM on 3/16/21.
36 2021-03-15 pain of skin, sensitive skin skin sensitivity/pain; skin sensitivity/pain; whole body achiness; sore throat; fatigue; This is a s... Read more
skin sensitivity/pain; skin sensitivity/pain; whole body achiness; sore throat; fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 36-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 12Feb2021 at 12:30 (at the age of 36-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included irritable bowel syndrome (IBS) and degenerative L5 disc. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levonorgestrel (MIRENA), vitamin B6, cranberry, and fish oil from unknown dates for unknown indications. The patient received BNT162B2 (dose 1; lot number EL3248; left arm) on 15Jan2021 at 13:00 for COVID-19 immunization. The patient previously received neomycin from an unknown date for an unspecified indication and experienced allergy. On 13Feb2021 at 10:00 the patient experienced whole body achiness, skin sensitivity/pain, fatigue, and sore throat. The patient did not receive any treatment for the events. The outcomes of body achiness, skin sensitivity/pain, fatigue, and sore throat were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
36 2021-03-16 redness, hives, rash Hives/swelling/redness and heat on face - started around 11 and still have them at 810 pm. Took a Be... Read more
Hives/swelling/redness and heat on face - started around 11 and still have them at 810 pm. Took a Benadryl at 750pm
36 2021-03-16 itchy skin, rash, hives allergic reactions; rash, itching, hives, and swelling of the face (specifically eyes)
36 2021-03-17 injection site pain I had my intern giving COVID-19 shots yesterday. This was the first one of the day. I asked her if s... Read more
I had my intern giving COVID-19 shots yesterday. This was the first one of the day. I asked her if she has done COVID shots before and she claimed she had. She said she has done them for her employer. I told her where she could find the vial of vaccine as well as the diluent supplied to reconstitute it. After giving the first shot, I asked her if she drew up the remainder of doses from the vial. She told me no, that it was just the single dose vial. I then asked her if she added the saline diluent, and she said no. She ended up injecting the full 0.45 ml of undiluted vaccine. I spoke to the patient 24 hours after the shot and she was experiencing the normal adverse reactions of injection site pain and joint pain. No other adverse reactions were reported.
36 2021-03-17 injection site pain Patient reports she received the COVID-19 vaccination "around 3:45pm on Friday, March 5th". States s... Read more
Patient reports she received the COVID-19 vaccination "around 3:45pm on Friday, March 5th". States she left clinic in good condition after waiting the designated amount of time for observation. Reports that in the "middle of the night, she had terrible pain" described as throbbing and rated 10/10 and "that made her cry". Reports pain was "at the top of her shoulder, on the bone". Also states "he top of her shoulder, on the bone' as the injection site. Denies any swelling, redness, rash, or bruising at the site. Reports she lost range of motion and couldn't mover her own arm. States she "had her husband do passive range of motion for her".
36 2021-03-18 skin warm 27 hours after vaccine, my left eye started to itch and felt dry. Overnight it began to swell to the... Read more
27 hours after vaccine, my left eye started to itch and felt dry. Overnight it began to swell to the point of being closed shut by 4:00am on 3/19. It was also warm and throbbed slightly. I took a Benadryl by 4:30am. Swelling reduced slightly. I took a 2nd Benadryl by 11am swelling reduced slightly. It is 316pm and eye is still swollen and warm to touch. Not swollen shut though. Swelling is all along eyelids, under and above eye and inner corner of eye.
36 2021-03-18 injection site pain Moderate soreness I?m at injection site. Still severe to touch. Can?t sleep on it but can exercise w... Read more
Moderate soreness I?m at injection site. Still severe to touch. Can?t sleep on it but can exercise with little pain. Continued inflammation. No other side effects noted.
36 2021-03-18 itchy skin Patient reported it was hard to swallow and had throat tightness and itching. She thought her voice ... Read more
Patient reported it was hard to swallow and had throat tightness and itching. She thought her voice was different. Patient evaluated with. Was given Epi and Benadryl. Continued to cough. EMS called and patient transported to Emergency Room for further evaluation.
36 2021-03-19 injection site pain I woke up the morning after getting my first shot with a 100.3 fever, very lightheaded, and had musc... Read more
I woke up the morning after getting my first shot with a 100.3 fever, very lightheaded, and had muscle aches. Lasted for one day and then I felt back to normal. A week after the first shot I woke up with intense pain at the injection site on Thursday and Friday.
36 2021-03-20 skin burning sensation, rash with redness, rash Had a severe headache by 4:00 pm and then began having chills and body aches and a very sore arm. We... Read more
Had a severe headache by 4:00 pm and then began having chills and body aches and a very sore arm. Went to bed and the following day was just feeling very fatigued. Then around 6 o?clock I started getting horrible chills bodyaches and a low-grade fever. A large red rash appeared and my arm was incredibly sore and the skin was burning. I have experienced body chills off and on since the vaccine.
36 2021-03-20 injection site pain, injection site swelling, injection site hardening, injection site mass, injection site redness, injection site bruising The I he turn itself was painless. By the time I got home from work, I had developed a large, red we... Read more
The I he turn itself was painless. By the time I got home from work, I had developed a large, red welt at site of injection. (Raised lump, solid/hard texture, like I had half a golf ball under my skin). Still tender to touch. The red is just now fading 3 days after the injection and leaving a bruise.
36 2021-03-22 injection site pain Symptoms included chills, elevated temperature (99.3), fatigue, aches, pain at injection site. was 3... Read more
Symptoms included chills, elevated temperature (99.3), fatigue, aches, pain at injection site. was 33 weeks pregnant at time of second dose of Pfizer vaccine. Symptoms subsided by the morning of 3/18/2021 with no other symptoms returning.
36 2021-03-23 rash, injection site rash 2-3 hours after receiving vaccine, I noticed an itchy throat and slight arm pain; on 02-27-2021, I w... Read more
2-3 hours after receiving vaccine, I noticed an itchy throat and slight arm pain; on 02-27-2021, I woke up with a headache and severe arm pain, couldn't lift it without extreme discomfort; at 1700-1800, I drove myself to get something to eat and after returning home I took two Tylenol for pain; after about 20-30 minutes of taking the Tylenol, I felt short of breath, my chest was tight, my heart was racing, and there was a burning sensation near the bottom portion of my heart, and I felt doomed so I drove myself to the ER because I did not want my children to witness me in distress; I was discharged o n 02-28-2021 with prescription for allergy medication and told to follow up with my HCP & cardiologist; on 03-01-2021 at 1444 a rash started on my left extending towards the injection site and my chest started to get tight, I left work and took a Benadryl and went to sleep; on 03-15-2021, the rash on my left arm reappeared but extended to the left neck and chest area and my chest started to get tight, so I took 2 Benadryl called my HCP for an appointment went to sleep; seen by HCP on 03-16-2021 who witnessed rash and was prescribed prednisone and referred to allergist for follow-up; symptoms were reported using V-safe
36 2021-03-23 itchy skin, hives About 30 min after receiving my first shot I felt itchy on my arms. About an hour after the shot, I ... Read more
About 30 min after receiving my first shot I felt itchy on my arms. About an hour after the shot, I realized my arms and legs had multiple hives. It was extremely itchy. I took Claritin and Tylenol about 2 hours after the shot an the hives and itchiness was gone by 6 hours after the shot.
36 2021-03-23 itchy skin Intense flushing and itching down face, neck and chest.
36 2021-03-23 rash Rash on face on face and neck, nausea, syncope. Patient refused epi, crew pushed 50 mg benadryl and ... Read more
Rash on face on face and neck, nausea, syncope. Patient refused epi, crew pushed 50 mg benadryl and oral gluacon 166/90, 100% RA,110, blood sugar 62
36 2021-03-24 injection site pain, rash, itchy skin, redness Rash all over my body, itchy, within 1.5 hours of receiving shot. Took Benedryl. Went away. When Ben... Read more
Rash all over my body, itchy, within 1.5 hours of receiving shot. Took Benedryl. Went away. When Benedryl wears off, rash comes back. Low grade fever developed 7 Pm first night and has been going away and coming back for two days along with chills. Extremely thirsty. Soreness of arm where injection was done. Redness. Occurred next day. Been using ice packs on arm and face. Face has bad rashes. Muscle and joint pains for the last day and a half.
36 2021-03-24 injection site redness, skin reaction, injection site warmth, injection site pain, injection site swelling, injection site pruritus Skin reaction to the 2nd Pfizer vaccine. Injection site is red, swollen, painful, hot and itchy. Wh... Read more
Skin reaction to the 2nd Pfizer vaccine. Injection site is red, swollen, painful, hot and itchy. When it began it looked like a mosquito bite, now two days later it has spread.
36 2021-03-24 redness While caring for another patient, I heard a code green called at a different location within the cli... Read more
While caring for another patient, I heard a code green called at a different location within the clinic. I ran to the location to find patient lying on the floor with the monitor standing next to her consoling her. Patient was awake alert and oriented times four but did not remember what happened. Slight redness located on the upper right forehead. Code Green called, EMTs arrived at scene and continued evaluation.
36 2021-03-25 itchy skin A few hours after vaccine began getting itchy all over and slight numbness on left side. Went to ER ... Read more
A few hours after vaccine began getting itchy all over and slight numbness on left side. Went to ER and was given benadryl. The next morning 3/22 I woke up with hair feeling in my throat and heart palpitations. Went back er BP and treated with hydrolyzed hcl, Famotadine, lorazepam and Prednisone. By the evening 911 was called and I was taken back to er BP for heart rate of 150 +, light headed and nausea. I was treated with clonazepam and discharged that night. On today 3/26 I am still experiencing fast heart rate and taking atarax as needed.
36 2021-03-26 injection site pain Fever (102F for 24hrs), whole body muscle pain, headache, injection site pain
36 2021-03-26 injection site pain Mild soreness following injection (1/28), however thank her the last 4 weeks (approximately) the pai... Read more
Mild soreness following injection (1/28), however thank her the last 4 weeks (approximately) the pain in my left upper arm/shoulder has gradually increased to constant ache and pain that is exacerbated with touch/pressure. I wake up throughout the night when I try to roll her because using that arm or laying on it is now quite painful. I have painful range of motion at the shoulder, and have no trauma or injury to that extremity other than having had the vaccine in that arm.
36 2021-03-26 vaccination site pain, injection site redness Pfizer-BioNTech COVID-19 Vaccine EUA Muscle aches, chills, high fever, headache, vaccine site sorene... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Muscle aches, chills, high fever, headache, vaccine site soreness and redness, swollen lymph node under right arm after second vaccine dose. Took extra strength Tylenol 1000mg as directed every 6 hours (limited to 6 pills in 24 hours). Fever peaked at 103 about 36 hours after vaccination, was back to normal at about 72 hours after vaccination. Headache, vaccine site soreness and redness, swollen lymph node under right arm persists 72 hours post vaccination.
36 2021-03-26 injection site hardening, injection site mass, injection site redness Redness and hard lump at injection site. Very swollen, tender, pain under right armpit and into righ... Read more
Redness and hard lump at injection site. Very swollen, tender, pain under right armpit and into right breast
36 2021-03-26 injection site pain The lower part of my forearm has a bad burning sensation. No redness or swelling. Injection site hu... Read more
The lower part of my forearm has a bad burning sensation. No redness or swelling. Injection site hurts as described it would.
36 2021-03-26 hives Warm sensation all over body, blurred vision in right eye, flushing, hives over chest, neck, and arm... Read more
Warm sensation all over body, blurred vision in right eye, flushing, hives over chest, neck, and arms, high heart rate and high blood pressure. Happened just minutes after injection. Given 50mg Benadryl and observed by Medics for an hour.
36 2021-03-28 injection site bruising, injection site pruritus, injection site swelling Swelling at injection site with mild itching. Started Sunday morning and has been improving since bu... Read more
Swelling at injection site with mild itching. Started Sunday morning and has been improving since but is still noticeable 24 hours later. Site is beginning to look slightly bruised
36 2021-03-28 hives Whole body hives for one day, no wheezing or SOB, days later hives wax and wane, managing with stero... Read more
Whole body hives for one day, no wheezing or SOB, days later hives wax and wane, managing with steroids and antihistamines
36 2021-03-30 injection site reaction, injection site redness Fever; body aches; fatigue; redness at injection site; muscle stiffness at injection site; This is a... Read more
Fever; body aches; fatigue; redness at injection site; muscle stiffness at injection site; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686, Expiration date: Unknown) via intramuscular route of administration in the left arm on 25Jan2021 10:00 at SINGLE DOSE for COVID-19 Immunization. The patient had no medical history and had no known allergies. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient was not having COVID-19 prior vaccination. On 25Jan2021 at 21:00 the patient experienced Fever, body aches, fatigue, redness at injection site, muscle stiffness at injection site. On 28Jan2021 post vaccination, the patient had nasal swab for COVID-19 test which was negative. The patient was not given treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
36 2021-04-06 hives swollen lymph node above my collar bone; chest tightness; issues breathing; hives; dizziness, headac... Read more
swollen lymph node above my collar bone; chest tightness; issues breathing; hives; dizziness, headache and severe lethargy about 1 hour after the injection; dizziness, headache and severe lethargy about 1 hour after the injection; dizziness, headache and severe lethargy about 1 hour after the injection; This is a spontaneous report from a contactable consumer reported for herself. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 17Mar2021 at 03:30 PM (at the age of 36-year-old) on the left arm at single dose for COVID-19 immunisation. Medical history included Asthma. The patient had no allergies to medications, food, or other products. Concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness, headache and severe lethargy about 1 hour after the injection on 17Mar2021 05:00 PM. The next day (18Mar2021), the patient felt chest tightness and issues breathing along with hives, today (24Mar2021) a week later, still have chest tightness with issues breathing, hives and now a swollen lymph node above my collar bone. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved. Information on lot/batch number has been requested.
36 2021-04-14 injection site pain, injection site swelling Immediate swelling/pain at injection site. Swelling reducing at 10 min. post vaccine.
36 2021-04-15 itchy skin Patient received first Pfizer COVID vaccine with subsequent shortness of breath, subjective throat s... Read more
Patient received first Pfizer COVID vaccine with subsequent shortness of breath, subjective throat swelling and ear pain/itching. Patient was taken to the ED for ongoing evaluation and is taking 50 mg of Benadryl, IV fluids, 125 mg of methylprednisone, and 20 mg famotidine followed by reevaluation. Patient had no additional symptoms and discharged.
36 2021-04-22 injection site swelling, injection site warmth - Swollen injection site over 2 inches and growing, warm to the touch - Doctor prescribed an antibi... Read more
- Swollen injection site over 2 inches and growing, warm to the touch - Doctor prescribed an antibiotic - Outcome to be determined
36 2021-04-24 skin discolouration having discoloration on her toes; she was having numbness and tingling; she was having numbness and ... Read more
having discoloration on her toes; she was having numbness and tingling; she was having numbness and tingling; her extremities, from the knee down and both her hands and feet were cold,ice cold; Tachycardia; palpitation/palpitation complications without doing anything straight away; Pulse keeps raising, elevating to 148-157/Pulse went to 209; shortness of breath and basically blasting of air; Difficulty breathing; Dizziness; Weakness; Syncope episodes; Costochondritis; chest pain; The initial case was missing the following minimum criteria: suspect product was not reported or specified. Upon receipt of follow-up information on 06Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jan2021 (Batch/Lot Number: EL3246) (at the age of 36-year-old) as single dose for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included topiramate (TOPAMAX) at 250 mg, daily (2 DF 100mg and 1 DF 50mg at bedtime) taken for migraine, start and stop date were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 (Lot Number: EK5730) for COVID-19 immunization. The patient reported that since the second vaccination experienced tachycardia, palpitation, shortness of breath and basically blasting of air, difficulty breathing, dizziness and weakness, all on 18Jan2021. She reported pulse keeps raising, elevating to 148-157, she had palpitation complications without doing anything straight away. Elevated pulse and tachycardia, that all started and that was very concerning, pulse went to 209 and that was when she got transported to the emergency room. The patient reported also syncope episodes, costochondritis and chest pain on Jan2021. On 26Mar2021 the patient experienced having discoloration on her toes, numbness and tingling and that her extremities, from the knee down and both her hands and feet were cold, ice cold. The patient was transported to the hospital by ambulance three times due to the events (hospitalizations on 22Jan2021, 30Jan2021 and 25Mar2021). The patient underwent lab tests and procedures which included Troponin, D dimer, electrocardiogram (EKG), Chest X ray, Full blood count (CBC), exercise electrocardiogram (TMT) all resulted: normal, nuclear stress test: unknown results and pulse 148-157, 209, all on unspecified date. The patient outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-04-26 rash, rash with redness Patient stated red rash developed down entire left arm 1 day following vaccination and persisted for... Read more
Patient stated red rash developed down entire left arm 1 day following vaccination and persisted for 3 days after. Patient reported to us 7 days following vaccination stating that rash has resolved now. She went to her doctor who told her to take diphenhydramine prior to next dose.
36 2021-05-02 redness, rash macular 5/1/2021 Drainage and weird taste in back of mouth 11:30a Slight redness left thigh warm to touch 12... Read more
5/1/2021 Drainage and weird taste in back of mouth 11:30a Slight redness left thigh warm to touch 12:30-1:15p Fatigue 12:30-current Nausea 12:30-current Headache 3:15-current Diarrhea 4:30-current Sore arm 8p-current General malaise, especially if standing up 9:30p-current Face pressure 11:30p-11:35p 5/2/2021 Shakes 5a-7a Chest pains 8a-current, intermittently Anal bleeding 2p, every bowel movement since, bright reed blood in toilet and on paper Lightheaded and faint called EMS Blood pressure 155/94 3p, they suggested to follow up with my PCP in AM Anal bleeding 5:30p Red streak R arm near injection site 6:15p-6:45p Red dots on L knee 6:15p-current (not itchy) Started period/spotting 1st one since conceiving last year. I am 12 weeks postpartum and exclusively breastfeeding. (light brown not heavy) 9:30p (with prior two children J did not start my period until babies were about one year old and weaning from breastfeeding)
36 2021-05-03 itchy skin, rash Swollen painful lymph nodes in left armpit and groin Rash on upper extremities and chest - not raise... Read more
Swollen painful lymph nodes in left armpit and groin Rash on upper extremities and chest - not raised, no heat, very itchy Itchy scalp
36 2021-05-03 rash, vaccination site pain woozy, about to pass out/like you are going to pass out; heavy breathing/breathing was heavy, voice ... Read more
woozy, about to pass out/like you are going to pass out; heavy breathing/breathing was heavy, voice was deep, like she really had to work to breathe; racing heart/heart was racing; rash/ rash was under the skin/ it started in the thighs and spread down her legs; vascular rash/ rash was under the skin/ it started in the thighs and spread down her legs/ it seems like a vascular reaction; pain at the injection site./super painful injection site; felt really really really poor; voice was deep; heavy chest, chest pain; heavy chest, chest pain; feeling woozy/woozy, about to pass out; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8737), administered in left arm on 01Apr2021 01:15 PM (at the age of 36-year-old) at single dose for so she could be protected from COVID (as reported). It was reported that vaccine was not administered at military facility and vaccination facility type was hospital (reported as patient drove up to vaccine clinic). The patient's medical history included acute lymphocytic leukemia from 1992 to 1996 and not ongoing (she was immunocompromised when she was young, she was a cancer survivor). No family medical history relevant to events was reported. The patient declined being sick at the time of vaccination. No patient's concomitant medications were reported. No prior vaccinations reported within four weeks. No additional vaccines were administered on same date of the Pfizer suspect. The patient previously took gentamycin, amoxicillin and flu shot, culture specific to the flu (as reported), and she experienced allergy with all three on 1996. Patient said that she was immunocompromised when she was young, she was a cancer survivor. She said that right after remission she developed a gentamycin allergy and, because of the gentamycin and amoxicillin allergy she was allergic to the flu shot, not the flu but the egg culture, because the egg culture can be that reaction. Patient also said that she had a reaction to a flu shot back in 1996 or something, it was the same rash that was with the COVID vaccine. It was reported that patient had her first Pfizer Covid vaccine dose on 01Apr2021. She reported side effects of heavy breathing, racing heart, feeling woozy, rash, and pain at the injection site. It was reported that she would like more information and she wanted to know if she should get the second dose of the vaccine. Patient had both an event to report and a question. She said she had done application, the first vaccine was 2 weeks before the present report and she was not supposed to get the second until this Thursday (19Apr2021), she needed to look at a calendar. She said 01Apr2021 was her first vaccine and that she did already report her events. She said she had a bad reaction that borderline sent her to the emergency room but she instead took a BENADRYL and she laid down and then felt really really really poor the next 5 days. She said she had a terrible reaction, she didn't feel like her throat was shut, her breathing was heavy, her voice was deep, her heart was racing, like she really had to work to breathe, not like losing her airway passage, just that she had to work to breathe, she had a heavy chest, chest pain, a racing heart. She said she could best correlate it to how feels like low blood sugar, like you are going to pass out. It was also reported that patient experienced woozy, about to pass out. She said she ended up what she'd call a vascular rash. She said it started in the thighs and spread down her legs. She said it was not a rash at the injection site, the rash was under the skin rather than a topical rash. She said she had a photo of it, that it seems like a vascular reaction. She would like to file a report with us because she said she felt like she did not get anything out, she had logged what happened to them and there was no correlation, no confirmation. She said she could send the photo to them. She said she was scared to get second vaccine, she wonders if she should do her due diligence to do second dose, or if she should skip it. She said there was no protocol in place, she had a telemedicine call with her doctor, there was no $200 fee due, her physician said it sounds like patient had more than a normal reaction. She said there were other things that are scary, her doctor told her she should speak to an allergist, but she said it would cost her like $600. She said she didn't feel good on immediate injection, she felt like she probably shouldn't be driving her car. She looked for her notes then she said her only normal reaction was a super painful injection site but not a rash. She said the vascular rash subsided with the use of BENADRYL. She said she could not afford an allergist to figure out what's going on. She asked why someone as small as her would get the same dose as a 200 pound man and why the doses of the vaccine were not specific to size or weight based. She also asked if based on symptoms will someone in the medical Information department advised her not to get the second dose. Events onset date were reported as 01Apr2021. The case was reported as non-serious by the consumer. No events required emergency room visit. She confirmed that she did have a telehealth meeting with her general practitioner (also reported as no events required physician office visit), she said she talked to them on the phone. No investigations assessment and relevant tests were reported. The outcome of events was resolved on 02Apr2021 for "rash/ rash was under the skin/ it started in the thighs and spread down her legs" and "vascular rash/ rash was under the skin/ it started in the thighs and spread down her legs/ it seems like a vascular reaction", resolved on 08Apr2021 for "heavy breathing/breathing was heavy, voice was deep, like she really had to work to breathe" and "voice was deep", and resolved on 05Apr2021 for all other events.
36 2021-05-06 vaccination site pain blood clot; anemia; knee down felt tingly/like her legs were falling asleep; knee down felt tingly/l... Read more
blood clot; anemia; knee down felt tingly/like her legs were falling asleep; knee down felt tingly/like her legs were falling asleep; could not sleep; She was feeling uncomfortable constantly/she did not feel well; Shortness of breath; Her arm started hurting/was just at the injection site; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) at the age of 36-years, via an unspecified route of administration in left arm on 04Apr2021 12:15 at single dose for COVID-19 immunisation. Medical history included had a pregnancy (a while ago, not ongoing). No other products. The patient stated that she experienced shortness of breath on 08Apr2021 (4 days after receiving the first dose), it got so severe on day 7 that she went to the ER on 11Apr2021. She started getting progressively more shortness of breath. Twice, she called the nurse line for her doctor and was advised to go to the emergency room. Added she could not catch her breath, and it was worse at night, could not sleep, so she went to the emergency room, she was in emergency room for 2 and a half hours and then went home. She wanted to know if the second dose could cause issues or if she should get it, added that the paperwork said that people should not get the vaccine if they received an adverse reaction to the first dose or any vaccination. She did not know if this was normal for it to get progressively worse and 2 to 14 days later. Patient wanted to know if the shortness of breath was something that can get worse, if this was a reaction to the vaccine even though it happened so many days later. Patient added it was the only thing she could think of and that her heart rate, oxygen levels, and everything was good minus she felt like she could not catch her breath. The doctor in the ER gave her anti-anxiety medicine, something with an L, but the doctor gave her that and it really seemed to help. It was kind of like, she did not know, it made her feel calm enough to fall asleep. Caller added that she has that and an salbutamol (ALBUTEROL) inhaler. She was not sure whether progressively worsening shortness of breath had gotten any better or was still going on, added that yesterday was the day she did not need either treatment medication. The day before, she took just the anxiety medicine and not the albuterol. Yesterday, she took none. During the day on 11Apr2021 (Sunday), she had called because she was feeling uncomfortable constantly. She has two children and all day she did not feel well. She told her husband she did not feel well at all. Sunday when she went to lay down, she could not sleep. Patient reported that as her shortness of breath subsided, her arm started hurting again, thought this began on 19Apr2021 and was not sure, it went away completely and was just at the injection site, probably lasting half a day or so and then it went away, clarified as left arm, same as injection. Caller added that 15Apr2021 was after the ER visit, was that she was standing up doing things and from her knee down felt tingly. Stated that knee down felt tingly on 15Apr2021, which was after her ER visit occurred, she was standing up and doing things. She had not been doing things for long periods but her knee down felt tingly. Added not like numb, but like her legs were falling asleep. She was preparing dinner and moving around and felt tingling in both legs. This probably lasted about three hours. She just kind of took it easy and it started to subside and then it was gone. While mentioned investigations, patient stated the ER did an EKG, where they put stickers and monitor her heart. They did a chest x-ray, and they took blood. She believed they checked for blood clot tests and anemia. Patient did not know any results but stated the doctor came into the room and told her everything was clear and nothing came back with anything on it. She stated the date was either the night of 11Apr2021 or the morning of 12Apr2021 for the tests. Outcome of the events shortness of breath and arm hurting was recovered/resolved in Apr2021; of the event knee down felt tingly/like her legs were falling asleep was recovered/resolved on 15Apr2021; while of remain was unknown. No follow-up attempts are needed. No further information is expected.
36 2021-05-06 hives, rash stiffness in her neck; pain neck; rash all over her neck/rash has gone on to her face; breaking out ... Read more
stiffness in her neck; pain neck; rash all over her neck/rash has gone on to her face; breaking out in hives through out her body; lip is swollen; bumps underneath her lip; rash is going inside her mouth; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8731, expiration date 31Jul2021, on 14Apr2021 at single dose for COVID-19 immunization. Family history included lupus, COPD, diabetes which her mother had and she basically got it so she could be around her mother. Concomitant medication was none. The patient had the shot last Wednesday (14Apr2021) and then by Saturday (17Apr2021) she had severe neck pain and stiffness in her neck, she couldn't move her neck. The pain was ongoing. She had no rash on her arm but she had rash all over her neck and she went to the doctor and they gave her a steroid shot because they thought maybe it could be something different. She had the steroid and she still breaking out in hives through out her body. They gave her a steroid shot on Monday (19Apr2021) but the rash had gone on to her face, her lip was swollen, there were bumps underneath her lip and the rash was going inside her mouth and even though she got the steroid shot she was still breaking out in new hives. She said she was going to have to go and go back to work she thought this was going to be quick and it was not. She did not have the name of the steroid injection or have a lot expiration to provide. They also gave her Naproxen for the stiffness in her neck and a muscle relaxer. The outcome of stiffness in her neck, pain neck and rash all over her neck/rash has gone on to her face was not resolved. The outcome of other events was unknown. No follow-up attempts are possible. No further information expected.
36 2021-05-09 redness, skin peeling, skin discolouration, bruising Patient received Pfizer COVID-19 vaccine on 12/27/2021 and 01/17/2021. Previously checked for COVID... Read more
Patient received Pfizer COVID-19 vaccine on 12/27/2021 and 01/17/2021. Previously checked for COVID-19 infection 12/13/2020, 01/23/2021 and 04/06/2021 and was negative on each test. On 01/18/2021, patient states she had low-grade fever, fatigue, myalgia. Took Tylenol. Patient contacted office on 01/22/2021 stating the night prior (1/21/2021)her heart rate was up to 209 and had numbness and tingling in both upper extremities. Also with sharp pain down her legs and her hands were very cold. Patient had started taking a Kelp supplement on 01/21/2021 which was recommended by a provider. Reported later reported that she "felt like a truck hit her." She also noted onset of chest pain. She went to urgent care for evaluation 1/22/2021. Patient felt lightheaded while in urgent care as she was about to have her blood pressure taken and passed out for approximately 2-3 minutes. Ammonia inhalant was used and patient woke up. During evaluation by physician, patient had another few seconds of loss of consciousness. No tonic clonic movements. No tongue biting. Patient was seen at urgent care and had syncope times 4 episodes. Patient was not postictal. No evidence of seizure-like activity. No urinary incontinence or tongue biting. She felt like she was going to pass out and mention to the urgent care staff . Patient was transferred to the ED for further evaluation. Was admitted under observation. It was felt that the initial episodes of syncope may have had a psychogenic component due to history of pseudoseizures/convulsive syncope. Cardiac enzymes were negative. Ultrasound negative for DVT. D-dimer negative. Chest pain was reportedly reproducible on admission. Was given diagnosis of costochondritis. Received Toradol, tramadol, Ativan. Orthostatics were performed in the morning after admission for observation and she passed out while standing. Was given 1 L IV fluids with resolution of orthostasis and blood pressure subsequently remained stable. There was report of tachycardia. It was felt that the tachycardia was due to reflex tachycardia in the setting of vasovagal syncope. Patient discharged on ibuprofen and Tylenol p.r.n. COVID-19 test negative at that time. Patient also admitted to Hospital 01/31/2021 through 02/01/2021 due to chest pain. Also had seizure-like activity in CT scan. Seen by Neurology. Patient was able to remember what she thought to be ?seizure?. She was asked to raise her arms while getting her CT and when she did she feel that her ?arms got frozen?. And that she could not talk while she was still hearing people around. She said "everything went south". She remembered the attending and her getting back to normal immediately afterwards. When patient seen by nurse on the medical floor nurse has described her to be alert oriented x3. CT brain: No acute abnormalities Driver's license has been suspended for at least 6 months through 08/2021. On follow-up visit via video visit 02/18/2021, patient reported ongoing shortness of breath at at rest as well as chest pain also with palpitations. Also noted lightheadedness with ambulation. Patient seen by Cardiology 03/12/2021. Holter monitor 03/16/2021 with few isolated PACs. Pharmacologic stress test 03/2021 negative for ischemia with EF 70%. 2D echo (03/16/2021) with normal EF. No significant valvular abnormalities found. Suggested chest pain may be due to costochondritis. Seen in the office on follow-up 04/01/2021. Noted coldness of hands and feet since 01/22/2021. Ultrasound bilateral lower extremities negative for DVT 01/2021. Onset of discoloration of feet 03/26/2021. Also noted occasional muscle spasms and cramping of the right lower extremity below the knee. Noted particularly metatarsals and lateral surface of right lower extremity. Referred for lower extremity PVR ( 4/7/2021) showed elevated arterial pressures throughout both lower extremities suggesting non-compressibility. ABIs therefore unreliable. Strong pulsatile waveforms are maintained metatarsal region bilaterally suggesting no evidence of a arterial insufficiency at rest. Flat line digital waveforms suggest small vessel occlusive disease or vasospasm. X-rays of the toes negative for significant abnormality. Patient referred to vascular surgery for urgent evaluation. patient also refer to Rheumatology on 04/07/2021. On follow-up 04/07/2021 patient continue to note ongoing chest pain as well as shortness of breath. Patient started on aspirin 81 mg p.o. Daily on 03/25/2021. Shortness of breath is constant, unable to walk prolonged distances. Distal 2nd digits bilateral feet are deeper purple in color compared with prior visit 04/01/2021. Noted paresthesias of entire body from head to toes. Noted cold intolerance for few weeks intermittently. Notes discoloration hands from wrist to fingers and below knees to toes. States her extremities are ?freezing.? Was using a heating pad. States when she washes her hand in warm water the discoloration improved. During hospitalization CTA chest ( 01/31/2021) was negative for PE. Showed nonspecific, bilateral axillary subcentimeter lymph nodes. Minimal right breast calcification. Patient states she had mammogram performed 01/2021 and no significant abnormalities found. Patient followed at doctors. Hematology/Oncology aware of CT chest findings. Notably patient received COVID-19 vaccination prior to CT chest. Repeat CT chest requested by insurance however denied by insurance company. Left axillary ultrasound 04/26/2021 showed small axillary lymph nodes which have a relatively benign morphology. The largest node is actually decreased mildly in size when compared to 01/31/2021. Right axillary ultrasound 04/26/2021 showed small axillary lymph nodes as seen previously with 1 top normal size round lymph node with an indeterminate morphology but unchanged in size when compared to 01/31/2021. Patient has not been able to work since 04/01/2021 due to overall symptoms. Previously was working from home. Also works as an MA but discontinued in 02/2021 with onset of symptoms in 01/2021. On evaluation 04/07/2021 patient noted to have tenderness palpation along left lower quadrant. Initial CT abdomen and pelvis was denied by insurance company. Abdominal ultrasound 04/13/2021 unremarkable. Patient seen by vascular surgery on 04/12/2021 and recommended patient to start applying nitroglycerin to toes as well as initiation of a Plavix 75 mg daily. Also agreed with referral to Rheumatology. Patient has not yet received an appointment. Information was faxed to Rheumatology however referral was also placed by vascular surgery to rheumatology group. On evaluation in office 04/28/2021, patient reported chest pain all night where she "felt like something sitting on her chest" with associated shortness of breath. Radiated to neck. Also noted intermittent palpitations which can last for 5 minutes with associated chest pain. Notes left groin pain for the last 2 days. Symptoms lasted 2 hours, from 11:00 p.m. to approximately 1:00 a.m. and patient subsequently fell asleep. On awakening patient continues to notes chest tightness but less. Patient feels weak today. While patient was being examined on the examination table patient appeared weak and stated that she felt like she was going to pass out. Then noted left arm numbness. When asked to raise arms, left arm elevation less compared with right. However subsequently patient had difficulty elevating both arms. Patient also not moving both lower extremities to command. With cranial nerve testing, cranial nerves 2-12 intact except patient was unable to smile on command however while patient was crying facial muscles appeared symmetric. Repeat BP 120/78 with heart rate 75 and O2 sats 99% on room air. Blood pressure repeated another 5 minutes was 115/75 with heart rate of 76. patient referred to the ER for immediate evaluation by ambulance. Patient has been admitted to the hospital since 04/28/2021. On 4/28/2021, patient noted bruising along right brachial area, right upper extremity distally as well as left medial thigh. Noted dry patch along dorsum of left foot with associated redness for the last 3 days. Purplish discoloration of 2nd left digit and 2nd right digit had subsided since this weekend prior to visit 4/28/2021 and area is now scaly on both toes. Has been using nitroglycerin b.i.d. to toes since 04/12/2021 at recommendation of vascular surgery. States per patient's coloration of feet bilaterally improves with exposure to warm water. Also has been elevating the lower extremities. Noted significant constipation for which patient was seen by GI. Has been using Metamucil and MiraLax. States constipation persists. States she has to use a step stool to elevate her legs when trying to have a bowel movement. States she spent a long time in the bathroom when she has to have a bowel movement. Also notes bright red blood per rectum with each BM with wiping as well as on the stool. States she did not have bright red blood per rectum at time of recent GI evaluation. EGD/colonoscopy was initially scheduled for 05/14/2021 prior to admission to hospital.
37 2020-12-31 injection site discolouration, injection site hardening, injection site pruritus, injection site bruising, injection site warmth Large bull eye bruise with ring of purple around injection site. Warmth and firmness at site, itchy.
37 2020-12-31 redness, rash, itchy skin Tuesday 12/29 - Initially pruritis, erythema and unraised rash to L antecubital fossa. Wednesday 12/... Read more
Tuesday 12/29 - Initially pruritis, erythema and unraised rash to L antecubital fossa. Wednesday 12/30 - Woke up with post nasal drip, congestion, scratchy throat, nausea. Pruritis, erythema and non raised rash to bilateral antecubital areas. Had intermittent chills without fever. Had muscle aching. Thursday 12/31 - Started to have pruritis to abdomen, no rash noted. Continue to have pruritis, erythema, non raised rash to bilateral antecubital areas. Continue to have post nasal drip, congestion, scratchy throat (none worse than the day before). No chills, only muscle aching. Friday 1/1 - Same as 12/31 so far.
37 2021-01-01 shingles Patient (physician) reported she developed shingles post-COVID vaccination.
37 2021-01-01 injection site pain soreness in left arm (site of injection) vertigo on 1/1/2021 at 5:30pm (dizziness that prevented sta... Read more
soreness in left arm (site of injection) vertigo on 1/1/2021 at 5:30pm (dizziness that prevented standing, nausea, extreme fatigue). Pt has never experienced vertigo before. On 1/2/21 some mild dizziness remains though the pt can resume normal activity in the home.
37 2021-01-02 injection site redness, injection site swelling, injection site pruritus Body aches, chills, exhaustion, fever, injection site itching, swelling and redness.
37 2021-01-02 injection site pain Nausea Joint pain Chills Muscle pain Headache Tiredness Injection site pain Vomiting
37 2021-01-03 itchy skin After~50 minutes from receiving the vaccine, I experienced bilateral numbness of the ears, cheeks, a... Read more
After~50 minutes from receiving the vaccine, I experienced bilateral numbness of the ears, cheeks, and tongue. This lasted ten to fifteen minutes followed by mild itching of the ears, face, and neck. Upon returning home, contacted my primary physician to report the adverse reactions and self administered Benadryl which eliminated the s/s thus far.
37 2021-01-03 hives Allergic reaction: after 10-15 min, got hives on arms and face, felt dizzy, fast heart rate (116), r... Read more
Allergic reaction: after 10-15 min, got hives on arms and face, felt dizzy, fast heart rate (116), rigors. The urgent response team started iv fluid 1L, gave solumedrol (IV) and Benadryl (IM). Paramedics transferred me to ER (which was downstairs in hospital). After 1 hour the hives faded and gone by 2h. They kept me for observation for 5h. I did not have any difficulty breathing, did not receive Epi.
37 2021-01-03 hives, rash severe fever; chills; severe night sweats; hives throughout my body; a rash on my face; This is a sp... Read more
severe fever; chills; severe night sweats; hives throughout my body; a rash on my face; This is a spontaneous report from a contactable nurse. This nurse reported for helf that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer), via an unspecified route of administration on Left Arm on 19Dec2020 10:30AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products:Cocoa butter. Concomitant medications were unknown. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "Starting seven hours after the vaccine, I experienced severe fever and chills. The next morning, despite multiple anti-pyretics, the fevers/chills were worse. Also I experienced severe night sweats, likely related to the fevers. Three days after the vaccine, I began to have hives throughout my body and a rash on my face. Responds to Benadryl, but eventually reappears." The event started from 19Dec2020 05:30 PM. Treatment was received for the adverse event included Anti-pyretics, anti-inflammatories, anti-histamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type vaccine was hospital. No other vaccine in four weeks. The patient recovered with lasting effects. No Covid prior vaccination. No Covid tested post: vaccination. The outcome of the event was recovered/resolved with sequel in Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events severe fever and chills, severe night sweats, and hives and a rash on face were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-04 vaccination site pain Headache; nausea; arm pain at the injection site; This is a spontaneous report from a contactable nu... Read more
Headache; nausea; arm pain at the injection site; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ek5730), intramuscular at the left arm on 23Dec2020 14:30 at a single dose for COVID-19 immunization. Medical history included anxiety. The patient was not pregnant at the time of vaccination and had no known allergy. Concomitant medication included trazodone and fluoxetine hydrochloride (PROZAC). On 24Dec2020 6 am, the patient experienced headache and moderate nausea for about 48-32 hours with significant arm pain at the injection site. The patient was not hospitalized for the events and did not receive any treatment. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020.
37 2021-01-04 vaccination site pain Headache; soreness at injection site; nausea; fatigue; This is a spontaneous report from a contactab... Read more
Headache; soreness at injection site; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown since misplaced/discarded) via intramuscular on 26Dec2020 17:30 on left arm at a single dose for COVID-19 immunization. The patient medical history included anxiety and attention deficit hyperactivity disorder (ADHD). The patient allergy for reglan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included atomoxetine hydrochloride (STRATTERA) and sertraline hydrochloride (ZOLOFT). The patient experienced Headache, soreness at injection site, nausea, fatigue on 27Dec2020 08:00 AM. The patient received Excedrin as treatment for the events. The outcome of the events was recovering. Information on the Lot/Batch number has been requested.
37 2021-01-04 hives Patient became lightheaded, flushed, tachycardic, and developed hives. Patient was administered 25m... Read more
Patient became lightheaded, flushed, tachycardic, and developed hives. Patient was administered 25mg of diphenhydramine orally and observed. Patient quickly began feeling better, hives disappeared. The patient left with 2 other coworkers.
37 2021-01-05 injection site pain Diarrhea Sore arm at site of injection 1 day tension headache
37 2021-01-05 rash Index and middle fingers in both hands broke out in what appears to be very similar rash to my nicke... Read more
Index and middle fingers in both hands broke out in what appears to be very similar rash to my nickel allergy; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection in the left arm on 28Dec2020 at 14:15 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergies to medications, food, or other products: nickel. Concomitant medications included ascorbic acid/biotin/tocopheryl acetate (BIOTIN GUMMY); ergocalciferol (VITAMIN D); and WOMEN'S ONE A DAY MULTIVITAMIN. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020, the patient experienced index and middle fingers in both hands broke out in what appears to be very similar rash to my nickel allergy despite the fact that I have not worn any jewelry or did anything out of the norm. Treatment was provided for the event rash included applying hydrocortisone and diphenhydramine (BENADRYL). The outcome of the event rash was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
37 2021-01-05 skin discolouration MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HE... Read more
MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HEART AND THEN THAT STOPPED AND TINGLING FEELING THROUGHOUT BODY AND THEN VERY WARM, AND FAINT FEELING. PATIENT DID NOT FAINT. PATIENT DID VOMIT ONCE. PATIENT HAD NOT EATEN BEFORE VACCINATION WAS ADMINISTERED. 1255 VITALS: BP: 126/91 P:100 SAO2 1303 VITALS: BP: 116/99 P: 96 SA02: 100% PATIENT STATES THEY ARE FEELING BETTER. GIVEN JUICE AND BANANA. 1312 VITALS: BP: 128/87 P: 74 SA02: 100% PATIENTS COLOR HAS RETURNED TO NORMAL. STATES THEY ARE FEELING MUCH BETTER. ABLE TO STAND AND WALK WITHOUT DIZZINESS. PATIENT STATED THAT THEY DID NOT FEEL THEY NEEDED ANY FURTHER TREATMENT OR CARE. PATIENT LEFT WITH HER WORKMATE.
37 2021-01-05 rash Woke up with a rash all over a few days later.
37 2021-01-05 vaccination site pain Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, ... Read more
Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; cold; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; feeling unwell that night, unable to sleep, tossing and turning all night; feeling unwell that night, unable to sleep, tossing and turning all night; This is a spontaneous report from a contactable nurse (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included food allergy (known allergies: raw bananas, avocados, melons, kiwi, tomatoes, oranges, grapes-make her mouth and lips itch). Concomitant medications were not reported. The patient previously received ibuprofen 400mg, a couple doses week prior. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Patient is not pregnant at the time of vaccination. On 29Dec2020, at 21:00, patient experienced worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dreams. When she was able to sleep, she was still feeling unwell the next morning like she was recovering from a cold. The patient did not receive treatment for the events. Outcome of the events was recovering. Since the vaccination, patient has not been tested for COVID-19.
37 2021-01-05 vaccination site redness, vaccination site hardening mild asthma attack; moderate dyspnea; chest pressure; a 4-5 cm area of induration; mild erythema in ... Read more
mild asthma attack; moderate dyspnea; chest pressure; a 4-5 cm area of induration; mild erythema in her left deltoid area; This is a spontaneous report from a contactable physician. A non-pregnant 37-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Unknown), intramuscularly in the left arm on 19Dec2020 at 37-years-old at a SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included intermittent asthma from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced the following events and outcomes: mild asthma attack on 21Dec2020 with outcome of recovering, moderate dyspnea on 21Dec2020 with outcome of recovering, chest pressure on 21Dec2020 with outcome of recovering, a 4-5 cm area of induration in Dec2020 with outcome of unknown, mild erythema in her left deltoid area in Dec2020 with outcome of unknown. The patient had intermittent asthma with no attacks in the past six years. Two days after the vaccination, she had a mild asthma attack when she was walking up stairs. For the past two days, she has had multiple asthma attacks, with moderate dyspnea and chest pressure present for most of the day. The patient's symptoms have been improving with her as needed (PRN) salbutamol (ALBUTEROL) inhaler. The physician saw the patient in a telemedicine visit and found her to have an asthma exacerbation; therefore, prednisone was prescribed. The patient had no symptoms of viral infection and reported testing negative for COVID-19 after the onset of her asthma symptoms. The physician suspected her asthma exacerbation to have been caused by the vaccine because she had been symptom-free in recent years and she has not had a new exposure other than the vaccine. In addition to her respiratory symptoms, the patient had a 4-5 cm area of induration and mild erythema in her left deltoid area; this appeared about 1 week after she received the vaccine. Therapeutic measures were taken as a result of mild asthma attack, moderate dyspnea, chest pressure. The patient, since the vaccination, had been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
37 2021-01-06 injection site pain 5 min after injection, pt developed L shoulder pain radiating to clavicle 4/10, now increasing to 6-... Read more
5 min after injection, pt developed L shoulder pain radiating to clavicle 4/10, now increasing to 6-7/10 and has decreased mobility of shoulder. sporadic burning sensation in arm between elbow and wrist.
37 2021-01-06 itchy skin, hives Extensive pruritus and mild urtiaria with premedication with Benadry, zyrtec and pepcid.
37 2021-01-06 injection site pain HEADACHE, BODY ACHES, LEFT ARM SORE AT INJECTION SITE, DIZZINESS
37 2021-01-06 injection site pain Headache neck pain/injection site soreness Narrative: injection site soreness lasted 24 hours; neck ... Read more
Headache neck pain/injection site soreness Narrative: injection site soreness lasted 24 hours; neck soreness for 36 hours; headache for several days
37 2021-01-06 injection site pain Per RN ->Patient received her Pfizer vaccine at 0835. At 0845, she came to me and reported that her ... Read more
Per RN ->Patient received her Pfizer vaccine at 0835. At 0845, she came to me and reported that her shoulder was achy and the pain rated 4/10 was radiating to her back. I checked the injection site and arm and it was not red, raised, or warm. Pt did not have any other symptoms, just the achy shoulder. Pt also reported a brief burning sensation in her shoulder that subsided within 1 minute. She later felt that same sensation in her forearm and it also subsided. It was recommended that she go to the ED for monitoring since the pain was radiating further from her shoulder. ED RN took her in at 0905 and I left.
37 2021-01-06 itchy rash Pruritic aculopapular rash across abdomen and lower extremities
37 2021-01-06 injection site mass, itchy skin, injection site redness Pt reported immediate redness and lump to injection site and shortly after developed flushing to fac... Read more
Pt reported immediate redness and lump to injection site and shortly after developed flushing to face/neck/arms with itching about 10 minutes after vaccine. Pt received Benadryl PO with recovery. Provider notified and approved course of treatment. No other f/u concerns at this time.
37 2021-01-06 injection site bleeding, injection site pain, injection site bruising had side effects of "tongue feels swollen and globus sensation in my throat."; had side effects of "... Read more
had side effects of "tongue feels swollen and globus sensation in my throat."; had side effects of "tongue feels swollen and globus sensation in my throat."; she did not have a lot of injection site pain, it very minimal.; bruise or ecchymosis at the injection site; bruise or ecchymosis at the injection site; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) via intramuscular on 19Dec2020 09:00 on left deltoid at a single dose for COVID-19 prophylaxis. The patient medical history, family history and relevant tests were reported as none. Current concomitant medications included multivitamin took 2 chewable gummies sporadically for years as supplementation therapy. The patient previously took Flu shots she got a sore arm. It was not bad. Tetanus gives her a sore arm, but that was all. Caller wanted to know what she should do for preparation to safely get second dose of Covid vaccine and how to fix what she was feeling right now, making sure it doesn't get worse, considering she is still having symptoms. Caller stated that she had side effects of tongue felt swollen and globus sensation in her throat. The transferring agent stated that he has a caller on the line that was calling about the Covid-19 Vaccine and reported that the patient got the shot on the 19Dec2020 and was inquiring about to proceed with her weird side effects. Caller had not told her physician about her symptoms yet. Caller clarified that she said a half an hour after the dose on 19Dec2020 09:30 she said that she had a Globus sensation or like a lump in her throat. Caller also reported that the back of her tongue felt swollen. Caller said that the Globus sensation was intermittent and it was not as prominent now as it was. Caller said that it was medically significant, but she has not sought medical treatment yet. Caller said that she still had a bruise or ecchymosis at the injection site. She said that the injection was high but reported that she did not have a lot of injection site pain, it very minimal. No emergency room or physician office required. The outcome of the event tongue felt swollen and globus sensation in her throat was recovering and the outcome of the event a bruise or ecchymosis at the injection site was not recovered and the outcome of the event minimal injection site pain was unknown.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded.
37 2021-01-06 injection site pruritus itchiness below injection site 15 minutes after the injection
37 2021-01-07 injection site pain Comparable to COVID symptoms I had in October. Fever, headache, aches, painful"bee sting" type at i... Read more
Comparable to COVID symptoms I had in October. Fever, headache, aches, painful"bee sting" type at injection site.
37 2021-01-07 injection site pain EE reports that EE received 1st Covid-19 vaccine on 12/29/2020. EE report that later that evening EE... Read more
EE reports that EE received 1st Covid-19 vaccine on 12/29/2020. EE report that later that evening EE began experiencing the following signs and symptoms of injection site pain, joint pain, headache, fatigue, and muscle pain. EE reports that EE was extremely fatigued on 12/30/2020 that EE was not able to work. EE called in to work on 12/30/2020. EE reports that EE has RTW work today, but is still experiencing the symptoms, but with improvement.
37 2021-01-07 itchy skin, hives Experienced moderate tension headache that same evening; asymptomatic the following 2 days. At 2:0... Read more
Experienced moderate tension headache that same evening; asymptomatic the following 2 days. At 2:00 am on 1/7/21 and 1/8/21, I woke up to severe face/ears/neck/and chest itching without rash. No trouble breathing. Upon waking had small welts that resolved within an hour. Contacted PCP, continuing to monitor should symptoms persist throughout the following nights. If symptoms persist for 1 week, will schedule an appointment with PCP.
37 2021-01-07 itchy rash Fatigue, sore left arm; Resolved. 12/29/2020 with pruritic rash to left forearm, chills, nasal conge... Read more
Fatigue, sore left arm; Resolved. 12/29/2020 with pruritic rash to left forearm, chills, nasal congestion, myalgias, then right forearm rash, itchy abdomen Benadryl/atarax without effect. COVID-19 test 12/28/2020 NEG result. Feeling slightly better today. COVID-19 test #2 scheduled for 01/04/2020.
37 2021-01-07 hives, itchy skin Reported itchy face covered with hives and one over eyelids very swollen. She was prescribed prednis... Read more
Reported itchy face covered with hives and one over eyelids very swollen. She was prescribed prednisone and symptoms resolved. Provided pictures in the email. She said her doctor advise not to take 2nd dose.
37 2021-01-07 injection site tingling Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more... Read more
Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches. Persistent sxs.
37 2021-01-07 rash papular developed raised striatians to abdomen and left and right flank area on 12/18/20 at 12 am, no treatm... Read more
developed raised striatians to abdomen and left and right flank area on 12/18/20 at 12 am, no treatment, resolved on 12/20/20 at 12 am.
37 2021-01-07 rash, rash papular patient states that on 12/18/20 she developed a raised rash to abdomen and left and right flank area
37 2021-01-07 injection site pain sinus congestion, pain at injection site Narrative:
37 2021-01-07 itchy skin tongue swelling, throat swelling chest tightness, itching neck
37 2021-01-08 injection site tingling After a few minutes of administration, I felt tingling down my right arm, my right side of the face,... Read more
After a few minutes of administration, I felt tingling down my right arm, my right side of the face, and my tongue. My eye started to hurt with pressure. The tingling in my arm and hand went away after 30 minutes or so but there was still some tingling of my face, toungue and the pressure of the eye still remained. That night I took a Zyrtec and felt better for a few days. on 1/8 I started to feel tinging in my tongue and pressure in my right eye again. I took Zyrtec that night and it went away. Currently this morning I feel okay and hope it wont come back.
37 2021-01-08 sensitive skin Approximately 10 hours after receiving the vaccine, I had a sore arm. Then experienced aches in my ... Read more
Approximately 10 hours after receiving the vaccine, I had a sore arm. Then experienced aches in my hip and knee joints, hot sweats alternating with chills, I did not take my temperature. I woke up the next morning with a headache and skin sensitivity. I took ibuprofen alternating with Tylenol and started to feel better. I felt back to normal about 36 hours after receiving the vaccine.
37 2021-01-09 redness First vaccine received 12/18/2020. Diagnosed with COVID-19 12/28/20. Illness lasted 4 days. Returned... Read more
First vaccine received 12/18/2020. Diagnosed with COVID-19 12/28/20. Illness lasted 4 days. Returned to work 1/8/21. Second vaccine dose received 1/8/21 at 11:30am. Muscle aches, chills, and fever started at 19:30 on 1/8/21 and persisted throughout the night retning every 4 hours while alternating Tylenol 650mg every 4 hours and Ibuprofen 600 mg every 6 hours. Last fever was at 12:30pm on 1/9/21. Chills without fever at 4am on 1/10/21. Sweats and right arm localized redness and soreness persisted through 1/10/21 at the time of this report.
37 2021-01-09 injection site pain, injection site redness Previous COVID 19 infection 2 weeks prior to 2nd vaccine. 8 hours after 2nd vaccine, muscle aches, c... Read more
Previous COVID 19 infection 2 weeks prior to 2nd vaccine. 8 hours after 2nd vaccine, muscle aches, chills, fever started. All symptoms persisted throughout the first night. Muscle aches, chills, and fever returned every 4 hours with alternation of Tylenol 650mg every 4 hours and Ibuprofen 600mg every 6 hours. Last fever was at 12:30pm on 1/9/21. Some chills without fever noted at 4am 1/10/21. Sweats and right arm soreness with localized redness to injection site have continued into 1/10/21 to the time of this report.
37 2021-01-10 injection site pain 1/9/21 Approximately 2:00 AM I was woken with Chills/joint pain/Injection Site Pain/Nausea had dizzi... Read more
1/9/21 Approximately 2:00 AM I was woken with Chills/joint pain/Injection Site Pain/Nausea had dizziness and weakness 1/9/21 Approximately 4:00 AM had headache/difficulty breathing/fast heartbeat along with the above 1/9/21Approximately 6:00 AM had a fever along with the above but the difficulty breathing and fast heartbeat had passed The remaining of Saturday Am I slept off and on with a terrible headache/difficulty catching my breath at times and taking IBP 2 times throughout the day/drinking plenty of fluids.
37 2021-01-10 itchy skin Approximately 15 minutes after receiving the vaccine, client started c/o itching to face and lips. T... Read more
Approximately 15 minutes after receiving the vaccine, client started c/o itching to face and lips. Transported to triage area. Where she started c/o burning lips also. vital signs monitored, Benadryl 50mg po given. In a few minutes she reported chest tightness, labored breathing. 1:44pm Epinephrine was given IM. client was on 02 increased to 15 Liters. She admits to decreased chest tightness and itching of face improving. She was taken by ambulance to hospital, where she was admitted overnight for observation. She was given Benadryl and epi X2 more time, once in ambulance and once at the hospital. She denies any problems since then. She did say that approx 3 weeks ago she was a contact to a case of covi
37 2021-01-10 rash Back rash
37 2021-01-10 rash Employee reports rash to torso running up to neck / chin, severe genralized body aches, fever, chill... Read more
Employee reports rash to torso running up to neck / chin, severe genralized body aches, fever, chills, headach. Was unable to function due to reaction for 24hours. Said all resolved. Did not seek treatment. Adivsed by Emp Health to not receive 2nd vaccine unless consults with MD for clearance.
37 2021-01-10 itchy skin Patient received the vaccine and had generalized itchiness at 1pm. At 1:30 pm, the patient received ... Read more
Patient received the vaccine and had generalized itchiness at 1pm. At 1:30 pm, the patient received one tablet of Benadryl 25 mg and itchiness symptoms improved.
37 2021-01-10 hives Urticaria on left side of face and neck; mild. No action taken. Self-limited. - started 7-10 minute... Read more
Urticaria on left side of face and neck; mild. No action taken. Self-limited. - started 7-10 minutes after vaccine - resolved within 2 hours
37 2021-01-10 itchy skin, rash, itchy rash got vaccine completed 1/5/2021, waiting 20 minutes to check for reaction. Drove back to work. By the... Read more
got vaccine completed 1/5/2021, waiting 20 minutes to check for reaction. Drove back to work. By the time i got back to work I had a very itchy rash from just above injection site on my left arm down to my belly. This rash finally went aware mid day on 1/6/2021 and i also had Nausea from the night of 1/5/2021 to 1/9/2021. I contact my Employee Health Department when i returned to work 1/7/2021.
37 2021-01-11 hives 1/8fever, chills, cold sweat, body aches, pain, 1/9 dizziness, vomiting bile, Hives on chest and b... Read more
1/8fever, chills, cold sweat, body aches, pain, 1/9 dizziness, vomiting bile, Hives on chest and belly twitching lips and slurred speech,
37 2021-01-11 redness Covid toes, red tender slightly swollen toes with mild purple discoloration at the tip of toes, deve... Read more
Covid toes, red tender slightly swollen toes with mild purple discoloration at the tip of toes, developed 3 days after receiving the first vaccine dosage in the series. I have tested negative for covid as of 1/10/21. It was initially thought that I had a skin infection from clipping my nails too short and was prescribed doxyclycline. I saw an improvement within a few days on the antibiotic but them saw a reappearance of the covid toes presenting symptoms on 1/8/21. I have since been told by a physician that I likely have covid toes and not a bacterial infection. I was told to take baby asprin and that is helping to reduce the symptoms. In the past few weeks I have had no symptoms of Covid besides the appearance of covid toes. I understand that covid toes are often a latent symptom and that the timing of the appearance of this symptom could be coincidental. I am mildly concerned that the first vaccine dosage could have caused a flair up of a potential previous covid infection or could have caused the red covid toes symptom itself.
37 2021-01-11 injection site pruritus, injection site redness, injection site swelling Just over a week after receiving the vaccine the injection site became red, swollen, and very itchy.... Read more
Just over a week after receiving the vaccine the injection site became red, swollen, and very itchy. Over the course of the following day and a half the swelling increased and the redness and itching got worse. After applying hydrocortisone cream there was some relief. By the next day the symptoms were almost entirely resolved.
37 2021-01-11 itchy skin, injection site pruritus Localized itching at the injection site that progressed up arm and neck causing the patient to becom... Read more
Localized itching at the injection site that progressed up arm and neck causing the patient to become slightly short of breath and concerned for her safety
37 2021-01-11 hardening, skin discolouration, bruising Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chill... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chills, body aches, fatigue/weakness, loss of appetite, headache, vision changes, swollen right axillary lymph node (hard, painful) 40hrs-60hrs after injection: fever steady around 101, headache, fatigue, swollen right axillary lymph node (no longer hard, more disperse, still painful) 60+ hrs after injection: swollen right axillary lymph node (disperse, painful, bruising/discoloration) emailed ob/gyn about concern for swollen lymph node turning into mastitis, but referred to PCP
37 2021-01-11 redness, rash with redness Sore left arm accompanied with a red bump the size of a quarter, mild headache, and fever of 100.8.
37 2021-01-11 injection site pain The morning after the 2nd dose of the COVID vaccine, I woke up with the above symptoms. They are imp... Read more
The morning after the 2nd dose of the COVID vaccine, I woke up with the above symptoms. They are improving with IBProfen and the symptoms did not prevent me from going to work. Fatigue, Headache, injection site pain, malaise and new or worsened muscle pain.
37 2021-01-11 sensitive skin extreme joint pain, fever and chills, muscle aching, severe head ache (lasting 3 days), excessive fu... Read more
extreme joint pain, fever and chills, muscle aching, severe head ache (lasting 3 days), excessive full body sweating x3 days, extreme fatigue (sleeping >16 hrs per day x3 days, 1 short bout of nausea, sensitivity to skin on back and legs i.e. a cotton shirt against my skin felt like it was burning me. loss of appetite. multiple doses of OCT analgesics/fever reducers. loss of scheduled work x2 days.
37 2021-01-11 rash fever, rash, lymphadenopathy
37 2021-01-11 rash rash initially has resolved, fever 100.1F, chills,headache, heart rate 120, fatigue SOB states sympt... Read more
rash initially has resolved, fever 100.1F, chills,headache, heart rate 120, fatigue SOB states symptoms occur in afternoon advised to see PCP
37 2021-01-12 injection site pain, injection site irritation Experienced general aches, headache, soreness and irritation at the injection site as well as muscle... Read more
Experienced general aches, headache, soreness and irritation at the injection site as well as muscle pain in the shoulders and back. Symptoms began around 2000 on 01/09 and subsided overnight between 01/10 and 01/11.
37 2021-01-12 injection site pain Following vaccination, I had a headache for few days along with some pain on injection arm. The hea... Read more
Following vaccination, I had a headache for few days along with some pain on injection arm. The headache continued and soon some fatigue and tiredness accompanied it for 7-10 days following vaccination. Then ten days after, I had an increase in symtpoms that included heightened fatigue, loss of appetite, feeling "cold"/ "hot" (no fever), and abdominal pain with nausea and some diarrhea. Two weeks after vaccination, I had an increased of fatigue and not feeling well, accompained by a fever of (101.5 F) and chills, sore throat, and lethargy. My symptoms of fever, chills, sore throat, body aches, congestion, and fatigue remained over the next few days and soon included chest pain and some increase work of breath. With two negative Covid tests through work, it was recommended I go to see a physician, who instead sent me to Immediate Care. There I had an EKG which showed sinus bradycardia and they sent me to ER due to my symptoms of chest pain and shortness of breath. At the ER, multiple tests were run to negative results. ER Physician suspects that some of my struggles could be related to Covid vaccine but that I also may have caught an non-Covid virus on top of it which led to acute bronchitis.
37 2021-01-12 shingles, rash Immunization given on Wednesday evening. On Friday evening, developed pain and rash near groin. Thou... Read more
Immunization given on Wednesday evening. On Friday evening, developed pain and rash near groin. Thought it was reactivation of HSV-1. However, it has been diagnosed as shingles.
37 2021-01-12 vaccination site pain Inability to move head; Shoulder and neck pain. Severe neck and shoulder pain day Seven; Shoulder an... Read more
Inability to move head; Shoulder and neck pain. Severe neck and shoulder pain day Seven; Shoulder and neck pain. Severe neck and shoulder pain day Seven; Severe pain at injection site; This is a spontaneous report from a contactable nurse (Patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ685), via an unspecified route of administration in left arm on 23Dec2020 14:00 at single dose for covid-19 immunization in hospital. Medical history included ankylosing spondylitis. Known allergies included sulfa antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. There was no vaccine in four weeks. The patient experienced severe pain at injection site on 24Dec2020 at 12: 00 PM for four days. Then on day 28Dec2020 and 29Dec2020, the patient experienced shoulder and neck pain. Severe neck and shoulder pain occurred on day 30Dec2020. The patient experienced inability to move head on an unspecified date. The patient went to doctor on 04Jan2021. The events result in doctor or other healthcare professional office/clinic visit. Treatment was unknown. The events were non-serious. The outcome of the events was unknow.
37 2021-01-12 rash, itchy skin Itching on trunk, arms and legs with severe rash over the course of several days Moisturizer, Benadr... Read more
Itching on trunk, arms and legs with severe rash over the course of several days Moisturizer, Benadryl, Pepcid, triamciclinone cream.
37 2021-01-12 rash, itchy rash, rash papular Rash covering my neck, breasts, abdomen and back. The rash is pink and slightly raised and itchy a... Read more
Rash covering my neck, breasts, abdomen and back. The rash is pink and slightly raised and itchy at times.
37 2021-01-12 rash papular, pain of skin, rash, skin warm about 12 Hours after vaccine - developed severe chills, headache, fever (102 F - with ibuprofen & ac... Read more
about 12 Hours after vaccine - developed severe chills, headache, fever (102 F - with ibuprofen & acetaminophen), severe muscle aches, could barely move or sleep About 24 Hours after vaccine - same symptoms continued but developed very painful golf ball size lump under left armpit (lymphnode) same side as injection; around noon - the fever started to break but remained elevated (101.7-101F); remaine din the low 100's all day with being on ibuprofen/acetaminophen and still achy/headaches but not unbearable About 48 Hours later - woke up at 3 AM with another 101 F - went to work but left around 9 AM not feeling well (may just have been from exhaustion from not sleeping well the previous 2 nights); lymphnodes still swollen and painful; 101 F around 7-8 PM About 72 hours later - no fevers, feeling better; developed rash on left arm below injection site (red, slightly raised, warm to touch, painful to touch but not itchy), lymph node still painful but not as big About 96 hours later - rash same size, slightly swollen, painful to touch; lymph node smaller in size but still painful to touch
37 2021-01-13 itchy skin Extremely itchy eyes and face with some swelling within 30 minutes of vaccination. Last for about 2... Read more
Extremely itchy eyes and face with some swelling within 30 minutes of vaccination. Last for about 2 hours
37 2021-01-13 rash, rash with redness, skin warm, itchy rash Itching red rash that is painful and warm to touch. Benadryl cream placed for itching, followed by h... Read more
Itching red rash that is painful and warm to touch. Benadryl cream placed for itching, followed by hydrocortisone cream and advil.
37 2021-01-13 redness On 1/9 had cold sore outbreak on right lower lip (not new). On 1/11 at 0730 started having changes ... Read more
On 1/9 had cold sore outbreak on right lower lip (not new). On 1/11 at 0730 started having changes in hearing mostly in right ear (never happened before) Also started having headache and red/swollen area below right eye. Uncertain of all related to cold sore or possible vaccine side effect?? Never had other symptoms with cold sore outbreak
37 2021-01-13 injection site pain Patient received her first dose of Pfizer vaccine on 1.8.2021. When receiving the vaccine, the patie... Read more
Patient received her first dose of Pfizer vaccine on 1.8.2021. When receiving the vaccine, the patient reports that her left cheek went numb. Patient reports the feeling came back the next day. Patient reports extreme soreness, to the point of not being able to use her arm. She also reports "excruciating" pain on her entire right side of the body that radiated into her knees and hips. Patient was seen by her PCP on 1.11.21. Patient was prescribed a steroid at the time. On 1/14, the patient returned back to work and describes her pain as tolerable now.
37 2021-01-13 itchy skin Received vaccine approx 4:25pm. At approx 4:50pm, while driving home, I started to feel "off", like... Read more
Received vaccine approx 4:25pm. At approx 4:50pm, while driving home, I started to feel "off", like something was wrong. Part of my tongue started to feel a bit tingly and itchy. I arrived home approx 5 minutes later, and took Diphenhydramine 50mg po. Parts of my tongue still felt tingly and itchy, and the right side towards the back was starting to feel a little swollen. I decided to have EMS bring me to the hospital in case I was having an allergic reaction. EMS arrived to my house at approx 5:15pm. My BP was significantly elevated (160's/90's - I am usually 110's/60's), and I was tachycardic at approx 100-105bpm (I am usually 70-80bpm). I had started to feel like the back of my throat was tightening a little bit. I did not have wheezing or severe difficulty breathing, or generalized itching, hives, or flushing. Once on the ambulance my throat was feeling tighter, so they administered Epinephrine 0.3mg IM, inserted an IV, and administered Dexamethasone 10mg IV. After a few minutes the tightness in my throat was gone and I was feeling more back to normal. BP and HR began to slowly trend down (BP 130's/80'sjust prior to arrival to hospital). I was seen by Nursing and a Provider shortly after arrival to the ED. My BP was still elevated (140's/90's) and HR was approx 90bpm. Provider stated that my posterior pharynx was not swollen. I was observed in the ED for approx 2.5 hours, and was discharged to home with instructions to take Diphenhydramine as needed and follow-up with my PCP within two days. BP and HR had normalized prior to discharge. They did not do any labs or tests (12-lead EKG was done by EMS en-route). The following day (today) I am tired and have a slight headache and occasional slight nausea but otherwise feel ok.
37 2021-01-13 injection site pain Severe chills/severe shaking, tiredness, headache, muscle pain, pain at injection site, nausea, not ... Read more
Severe chills/severe shaking, tiredness, headache, muscle pain, pain at injection site, nausea, not feeling well. I had to stay home from work the day after the vaccine, I stayed in bed all day with a space heater on to 90 degrees in my bedroom just to get rid of the chills, I took Motrin 800 mg around the clock, Zofran as needed and I drank a lot of water.
37 2021-01-13 vaccination site pain Soreness to injection site; Headache, mild; This is a spontaneous report from a contactable nurse, t... Read more
Soreness to injection site; Headache, mild; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration, on 07Jan2021 at 17:00 PM (at the age of 37-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, and polycystic ovaries. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), ubidecarenone (COQ10). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. On 07Jan2021 at 21:00 PM, the patient experienced headache, mild. It started 4-5 hours after, continued to next day. The next day, 08Jan2021 the patient experienced soreness to injection site. The events were reported as non-serious. The patient did not receive any treatment for the headache, mild and soreness to injection site. The clinical outcome of the events headache, mild and soreness to injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the Lot/Batch number has been requested
37 2021-01-13 vaccination site pain Throbbing at the injection site; muscle aches over whole body; This is a spontaneous report from a n... Read more
Throbbing at the injection site; muscle aches over whole body; This is a spontaneous report from a non-contactable other healthcare professional. A 37-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular at the right arm on 07Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, alcohol, salicylates. The patient's concomitant medications were not reported. The patient was not pregnant when she received the vaccination. The patient previously received the first dose of bnt162b2 for COVID-19 immunization. On 07Jan2021 at 10pm, the patient experienced throbbing at the injection site and muscle aches over whole body. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
37 2021-01-14 rash, itchy rash, rash with redness 2nd vaccine given on Saturday 1/9 at 1030. Woke up with severe body aches, shivering, headache, naus... Read more
2nd vaccine given on Saturday 1/9 at 1030. Woke up with severe body aches, shivering, headache, nausea on Sunday morning at 02:30. This continued the rest of the day but was improved with Aleve. Woke up on Monday feeling well. Monday afternoon started developing a rash on bilateral thighs and arms. The rash was itchy and inflamed. Took Benadryl 12.5mg the next 2 nights. Wednesday the rash had improved, still pinkish but not red. Thursday the redness had resolved, but was still itchy. The itching continues today, but very mild.
37 2021-01-14 injection site pruritus, injection site pain, redness At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progre... Read more
At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progressed to myalgias in my back, especially lower back, neck, and right arm. At 2300, I started to have fever/chills, up to 39 C orally. This only partially responded to Tylenol. I was not able to sleep. At 2:30 am I noticed an unusual headache, 8/10, as well as bilateral eye pain on Moving eyes side to side as well as sensitivity to light. Headache was mostly frontal, which came and went every few minutes until exactly 11:38 am on 1/14/2021, when the fever and myalgias very suddenly got significantly better. Almost exactly 24 hrs to the minute after injection. On 1/15/2021, I still have significant pain in my left arm, swelling, redness and, now, itching at the injection site. My lower back still hurts.
37 2021-01-14 injection site bruising Bruise at the injection site, about the size of a quarter.
37 2021-01-14 rash, redness I had a couple of heart palpitations the first 5 mins, the next 2 hours I could feel my heart beati... Read more
I had a couple of heart palpitations the first 5 mins, the next 2 hours I could feel my heart beating but wasn't irregular, I took a shower I realized I had a rash on my arms and thighs (front), did not hurt or itch, pinprick bumps, it felt like sandpaper. I had facial flushing, felt hot and turned red, I took pepcid and benydryl, I went to sleep because that was the end of my shift . The rash stuck around for 1.5 weeks for the rash to go away . I woke up 6 hours after and felt fine I only had the rash and I went to occumed to document my symptoms and everything was fine after that
37 2021-01-14 injection site swelling, injection site warmth, injection site pruritus, injection site redness Local injection site reaction. Hot, red, swollen, itchy. Reaction site area 2.5 inch circumference. ... Read more
Local injection site reaction. Hot, red, swollen, itchy. Reaction site area 2.5 inch circumference. Application of ice and Benadryl cream, anti inflammatory medication
37 2021-01-14 injection site pain Mild headache and fatigue 1/13 after the vaccine administration 1/14 starting around 1400: increase... Read more
Mild headache and fatigue 1/13 after the vaccine administration 1/14 starting around 1400: increase in muscle aches, headache, fatigue and chills rested and took motrin Expected site pain
37 2021-01-14 vaccination site redness, vaccination site swelling Tiredness; headache; muscle pain; fever; feeling unwell; nausea; joints pain; injection site swellin... Read more
Tiredness; headache; muscle pain; fever; feeling unwell; nausea; joints pain; injection site swelling/redness; injection site swelling/redness; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),Batch/lot number: EK9231, intramuscular in the right arm, from 07Jan2021 07:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Jan2021 02:30, the patient experienced tiredness, headache, muscle pain, fever, feeling unwell, nausea, joints pain and injection site swelling/redness. The outcome of events was not recovered. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
37 2021-01-14 rash rash on her face/rash all over her body with most of it on her left arm/rash was small, close togeth... Read more
rash on her face/rash all over her body with most of it on her left arm/rash was small, close together bumps; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 and expiry date: unknown, vaccine location: right arm, dose number: 1), via an unspecified route of administration on 08Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included allergies: kiwi fruit and pollens. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified other medications within two weeks of vaccination. The evening of 08Jan2021 at 18:00, the patient noticed a rash on her face. She thought maybe it was from wearing her mask. The next morning, she woke up with the rash all over her body with most of it on her left arm. This is the opposite arm she received the vaccine. The rash was small, close together bumps. There was no pain or itching with the rash. No treatment was received. The patient was not tested for COVID post vaccination. Outcome of the event was not recovered. The event was reported as non-serious. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
37 2021-01-14 rash macular, itchy skin, rash ~10pm, tickle in throat ~ Midnight dry cratchy cough related to tickle in throat ~10pm, itchy wrist... Read more
~10pm, tickle in throat ~ Midnight dry cratchy cough related to tickle in throat ~10pm, itchy wrists, bilaterally, progressed to back of neck, insides of arms, lower legs, tops of feet, upper chest, under breasts, and splotchy face. ~10-midnight - rash in all same areas of itchiness
37 2021-01-15 rash macular, itchy skin, rash The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I ... Read more
The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I asked her if she had any history of anaphylaxis. She said she did to morphine. Her bp was 119/74 with a pulse of 94. She said her nose was starting to get itchy, her ears and scalp were itchy, and her eyes were blurry. She had red blotches all over her neck and chest. She said her throat was tight. She was able to swallow the water she requested. I gave her 50mg of benadryl. She had no visible signs of being unable to breathe. I explained to her we could call 911. She reported she had no insurance. She said she was on her lunch break at the hospital and wanted to get back. She did walk back across the street unassisted. Clinical observer, followed her over just to verify she made it in the building. She ended up checking herself into the ER instead of returning to her shift.
37 2021-01-16 injection site pain, injection site redness, rash, injection site hardening Rash covering my front and back torso, Left thigh, BUE. Also still have huge red area on left deltoi... Read more
Rash covering my front and back torso, Left thigh, BUE. Also still have huge red area on left deltoid 3 weeks after my injection. I have tried Benadryl and Pepcid to see if it was a histamine reaction that I could stop. Also I now have a psoriatic arthritis flare and my plaque psoriasis is not being managed by topical treatments. The rash started at about day 5 and continues presently. The injection site was indurated and tender x 14 days.
37 2021-01-17 itchy skin, redness, skin warm, rash papular, rash with redness, rash "On 1/15/21 my right forearm got a bit of a rash that was raised and red. Little island dots up my r... Read more
"On 1/15/21 my right forearm got a bit of a rash that was raised and red. Little island dots up my right arm, itching in my chest. My right knuckles were red, warm, swollen and sore as well as my left but to a lesser extent. Oddly enough I got all my vaccines in my left arm. On 1/15/21 I also noticed my knees were warm and sore but did not look at them. On 1/17/21...{knees and knuckles} Swelling, redness, hot to the touch, a little sore."
37 2021-01-17 itchy skin 24 hrs hrs after had high fever to 101, chills, rigors, myalgias, dizziness, headache, nausea, minor... Read more
24 hrs hrs after had high fever to 101, chills, rigors, myalgias, dizziness, headache, nausea, minor arm soreness and itchiness . 48 hrs after developed supraclavicular tender lymphadenopathy, neck stiffness, and continued headache. Headache lasted 5 days.
37 2021-01-17 hives 7 days later diagnosed with pneumonia; 3 days after developed hives on my stomach and arm; felt tire... Read more
7 days later diagnosed with pneumonia; 3 days after developed hives on my stomach and arm; felt tired; confused; unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on the left arm on 28Dec2020 12:00PM at a single dose for COVID-19 immunization at hospital facility. Medical history included Hashimotos disease. The patient had no known allergies and has not had COVID prior to vaccination. The patient's concomitant medications were not reported. The patient reported that she felt tired and confused and unwell on day of injection, 28Dec2020. After three days (31Dec2020), she developed hives on her stomach and arm and seven days later (04Jan2021), she was diagnosed with pneumonia and continued to have hives all over her legs and arms to this day. The patient was treated with antibiotics for pneumonia. She underwent Covid test/ Nasal swab post vaccination on 09Jan2021, pending result. The outcome of the events was not recovered.; Sender's Comments: The reported pneumonia was more likely an intercurrent disease, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-17 hives, skin warm, itchy skin, rash papular, redness Hives appeared on right arm, then left wrist starting around 6:00pm on Sunday 1-17-21. It slowly beg... Read more
Hives appeared on right arm, then left wrist starting around 6:00pm on Sunday 1-17-21. It slowly began to progress to my legs, torso, and feet by 8:30pm. The rash was raised, hot, and red. Blanchable to touch and extremely itchy. I used Benadryl 50mg (taken at 8:45pm) and hydrocortisone cream to alleviate the rash. This helped until Monday 1-18-21 at 06:00am. The rash began to return so I took another 50mg of Benadryl. The rash again cleared until 10:00am, at which point I scheduled a virtual visit through portal. I was prescribed prednisone and Famotidine. The rash continues to reappear once the Benadryl has worn off. Today I have taken one dose of prednisone and a total of 3 doses of Benadryl.
37 2021-01-17 vaccination site itchiness, vaccination site redness Redness, itching, hives on and around injection site; Redness, itching, hives on and around injectio... Read more
Redness, itching, hives on and around injection site; Redness, itching, hives on and around injection site; hives on and around injection site approximately 5 hours; This is a spontaneous report from a contactable nurse who reported for herself, a 37-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown) at the Workplace clinic, intramuscular in the right arm on 08Jan2021 at 16:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Patient had no COVID prior to vaccination, and was not COVID tested post vaccination. The patient was not pregnant. There were no concomitant medications. The patient previously took and had known allergies to morphine and Hep B vaccine preservative. The patient previously received the first dose of BNT162B2 (unknown lot number) on 18Dec2020 at 11:45 AM, at 36 years of age, via intramuscular in the right arm for COVID-19 immunization. On 08Jan2021 at 21:15, the patient experienced redness, itching, hives on and around injection site approximately 5 hours after 2nd dose, still present 2 days later. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information on lot/batch cannot be obtained. No further information is expected.
37 2021-01-17 injection site swelling The patient describes her symptoms as pins and needles on the right side of her body including burni... Read more
The patient describes her symptoms as pins and needles on the right side of her body including burning of the right foot. The injection site is swollen as well. The patient also describes a right foot injury including fracture occurring on 1/7/21. Mild symptoms started on the evening of 1/15/21. On 1/16, she awoke with numbness on the right side of the body. On 1/18 the symptoms evolved into pins and needles. This was the second dose of the vaccination series. The first dose caused some chills lasting several hours. The patient was seen at an urgent care earlier in the day, but reports not receiving a conclusive answer as to the basis of her symptoms. She stated that she intends to be seen at the ER. As a pharmacist I can not provide any additional workup, which was explained to the patient.
37 2021-01-17 itchy skin, hives Vaccine given at approx. 1608, Patient developed full body itching, chest tightening, and tingling t... Read more
Vaccine given at approx. 1608, Patient developed full body itching, chest tightening, and tingling tongue approx. 8 minutes after the vaccine injection. Patient denies difficulty breathing or swallowing. Vitals taken: HR 88, BP 121/72, RR 20, SPO2 97% on RA. Diphenhydramine 50mg IM in left arm at 1627.. At 1700 tongue started tingling again with new hives on chest. At 1707 Hydrocortisone 100mg IM given in right ventrogluteal muscle. At 1746 patient feels no tongue tingling or lip swelling and itching has subsided, Denies difficulty breathing or swallowing. Patient released home.
37 2021-01-18 injection site pain, injection site discomfort, injection site warmth 1 st dose- 5 hours after given experienced - cold to lower extremities , and hands. Followed by nigh... Read more
1 st dose- 5 hours after given experienced - cold to lower extremities , and hands. Followed by night sweats during the night. Following day some discomfort at injection site, and muscle pain to left side of body, mostly in gluteus . Fatigue lasts 2 day after injection. 2nd dose- at time of injection sensation of warmth in right arm with pain to site. 6-7 hours later joint pain in hands, injection arm elbow, and right knee, some dizziness. During night increased pain in injection site, continued joint pain, new symptoms muscle pain in gluteus and lower calf's all left side. Around 4 am woke up with extreme headache, nausea, and joint/body stiffness. Symptoms subsided through the day, by evening around 7 pm only some joint pain, and injection site discomfort. Fatigue remains.
37 2021-01-18 skin warm 12 hours after shot I got extreme chills and fever once fever broke I was dripping in sweat and very... Read more
12 hours after shot I got extreme chills and fever once fever broke I was dripping in sweat and very hot to touch this happened 3 times in the full 20 hours than ended around 10:30 pm Sunday than Monday at 4 pm had the chills and fever again this happened two times last fever was 9:30 pm
37 2021-01-18 itchy skin, hives, redness Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was hav... Read more
Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was having a hard time swallowing which progressed to tongue swelling, all taste buds popped up and sore, hives on face & neck, reddened face. Itchy neck and face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling all over body. Woke up feeling heaviness as if she had "sumo wrestler" on her body. 24 hours post vaccine heaviness started to lift but felt as if she had a vise on her lungs. Continuing to take Atarax every 6 hours per MD order.
37 2021-01-18 injection site pain Lymphadenopathy in left arm (contralateral to injection site) Soreness in right arm (injection site)
37 2021-01-18 injection site pain, injection site warmth, injection site swelling, injection site mass, injection site redness Symptoms reported by patient Received vaccine on 1/4/2021 @ 0950. Vaccine was given on side of lef... Read more
Symptoms reported by patient Received vaccine on 1/4/2021 @ 0950. Vaccine was given on side of left arm. On the evening of 1/5 I started to not feel well. I had a runny nose, headache, nausea, and fatigue. The injection site on my left arm was red, warm, and swollen with a knot/ball that could be felt underneath. I also had moderate pain at injection site. This was about the size of a half dollar. On the morning of 1/6 I still didn't feel well. I received a call from my mom that she tested positive for COVID and although I did not have much contact with her there was one day on 12/26 that I saw her outside for about 15 minutes (masked). I called employee health with all of this as it was hard to separate the exposure from symptoms of the vaccine. I did express some concerns over having a vaccine reaction but was told the symptoms I was having would be normal. I was tested for COVID, which was negative. Over the next few days symptoms got better but I did have nausea on and off until the morning of 1/11. Redness at injection site, swelling and pain were resolved by 1/11 as well. On Friday 1/15 I woke up and my injection site was red, warm, swollen, and had pain again. This was about the size of a quarter. There was also a hard area that could be felt under the skin. My arm hurt with radiating pain into my wrist. I thought maybe it was just random and it would go away. It slowly resolved through out the day and was mostly gone by Saturday 1/16/21. The only thing left was a faded red area about the size of a nickel. Friday evening ,1/15, I started to not feel well with body aches, joint pain, headache, and pain from injection site that radiated to my chest (this was intermittent). I also had a low grade fever (highest temp 99.9). I still did not feel well on Sunday but some symptoms were improved (pain radiating to chest was better and no more fever) but still had fatigue and body aches. I had a rapid COVID test done which was negative on the evening of 1/17/21. On 1/18 I felt better but towards the end of the day started to feel fatigued with body aches and headache. I contacted employee health for further follow-up.
37 2021-01-19 injection site tingling Experienced some tingling in the left arm starts at the injection site and radiates down to the fing... Read more
Experienced some tingling in the left arm starts at the injection site and radiates down to the fingers. can feel the sensation in all 5 fingers, fingers feel cool to the pt but her hands feel of equal temp to the examiner, was able to use her phone to text
37 2021-01-19 injection site swelling Fever, chills, diarrhea, swollen armpit on side shot was given, swollen in a where shot was given.
37 2021-01-19 injection site pain, injection site reaction, injection site redness Generalized muscle weakness, lethagy, body aches, headache, injection site erythema, redness, and mo... Read more
Generalized muscle weakness, lethagy, body aches, headache, injection site erythema, redness, and moderate pain. Injection site reaction is approximately 2cm x 3cm.
37 2021-01-19 itchy skin ITCHY SKIN . RAPIND HEART RATE. ED VISIT OBSERVE.
37 2021-01-19 injection site redness, injection site swelling, injection site pain Injection site was red, very painful, and swollen. About 30 hrs after injection I experienced joint... Read more
Injection site was red, very painful, and swollen. About 30 hrs after injection I experienced joint pain, overall not feeling well, and chest tightness (different than my last anxiety attack). 12 hours later those symptoms were gone but then I had a headache and nausea that resolved shortly after.
37 2021-01-19 rash Rash on chest and arms-started a week after vaccine
37 2021-01-19 rash Rash started within 12 hrs after vaccine shot. Rash has progressively spread across the entire body ... Read more
Rash started within 12 hrs after vaccine shot. Rash has progressively spread across the entire body since injection.
37 2021-01-19 redness, rash vesicular, hives, itchy skin Started off getting very itchy, then hives developed, and I turned red, I became very hot...24 hours... Read more
Started off getting very itchy, then hives developed, and I turned red, I became very hot...24 hours later I had flu like symptoms along with a blistering rash on my neck, face and scalp..with a few spots on my chest and back. These started to heal 5 days after injection, then started to resurface. On Day 3 I started getting short of breath and intermittent chest pains accompanied by a heart rate ranging from 110 to 126. I developed a severe headache and fatigue.
37 2021-01-20 injection site pain About 12 hours after I have very serve fatigue. About 12-18 hours still tired and couldn't think cle... Read more
About 12 hours after I have very serve fatigue. About 12-18 hours still tired and couldn't think clearly. About 24 hours after I was having chills. The next day still tired but improved. Randomly on and off I was having high BP. For the next week I had off and on high BP and palpitations. The injection site hurt for 1-2 days but very mild. I took Tylenol and Ibuprofen before the shot. The most disturbing was the increase blood pressure and palpitations. It was on and off.
37 2021-01-20 injection site pain, injection site swelling, injection site discomfort, injection site warmth, injection site pruritus Delayed injection site reaction occurred on day 4 post second vaccine. Arm swollen, hot to the touch... Read more
Delayed injection site reaction occurred on day 4 post second vaccine. Arm swollen, hot to the touch, tight, itching and painful. Swelling, heat, pain, itching continued to spread from injection site in left deltoid down entire upper arm to elbow by day 8 post vaccine (today).
37 2021-01-20 vaccination site warmth, vaccination site pain, vaccination site swelling Got acute pain in my stomach/stomach pain; Diarrhea; Passed undigested food; Fatigue; A little confu... Read more
Got acute pain in my stomach/stomach pain; Diarrhea; Passed undigested food; Fatigue; A little confusion; Muscle pain at the site of injection; The site was also hot and swollen for at least 12 hours; The site was also hot and swollen for at least 12 hours; This is a spontaneous report from a contactable Other HCP. This 37-year-old female Other HCP (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK3730, Expedite date:Mar2021 ) at single dose for COVID-19 immunization on 31Dec2020, 10:30 AM. Relevant history was unknown. Relevant concomitant drugs included citalopram 40mg daily, alprazolam 0.5 mg as needed. About 3-4 hours after injection, the patient got acute pain in her stomach. She had diarrhea and stomach pain for 5 days. She passed undigested food for about 3 days. Day of injection she had fatigue, a little confusion, and muscle pain at the site of injection. The site was also hot and swollen for at least 12 hours. No treatment was received. The outcome of events was resolved. The patient had not COVID prior vaccination. The patient had not have COVID tested post vaccination.
37 2021-01-20 injection site swelling, injection site pruritus Headache Beginning within 10 minutes of first injection (Pfizer Lot EL0142 administered 12/30/20) an... Read more
Headache Beginning within 10 minutes of first injection (Pfizer Lot EL0142 administered 12/30/20) and continuous, but exacerbated by second injection; Blurred vision; nausea; toe and finger cramping; chills; right eye and cheek spasm with numbness; swelling and itchiness at vaccine site; pain in left arm from second injection; fever 3 degrees above baseline
37 2021-01-20 redness Low grade fever- slept it off, drank fluids Skin slightly red(arms, legs & cheeks) & slightly warm -... Read more
Low grade fever- slept it off, drank fluids Skin slightly red(arms, legs & cheeks) & slightly warm - no treatments, put on lotion to slightly cool
37 2021-01-20 shingles, rash papular One day after receiving dose #2, I developed aching left lower back pain and tingling/pins and needl... Read more
One day after receiving dose #2, I developed aching left lower back pain and tingling/pins and needles sensation on front of left thigh. I made a PCP 6 days later as symptoms were not subsiding. Clusters of raised rash appeared 2 days after PCP visit (9 days after second dose of vaccine). At that time I was diagnosed with shingles.
37 2021-01-20 injection site pain, injection site swelling Pain and swelling at ejection site throughout upper arm, shoulder and shoulder joint. Fatigue. Light... Read more
Pain and swelling at ejection site throughout upper arm, shoulder and shoulder joint. Fatigue. Lightheadedness.
37 2021-01-20 redness, hives, itchy skin Patient developed itchy hives to body 10 min post-vaccination. She also reported burning feeling to ... Read more
Patient developed itchy hives to body 10 min post-vaccination. She also reported burning feeling to her face and itchy mouth. No swelling noted or reported. Skin red.
37 2021-01-20 injection site pruritus, injection site pain, injection site warmth, injection site redness Red, itchy, painful bump at injection site, warm to touch
37 2021-01-20 vaccination site pain Soreness at the injection site/arm; Soreness at the injection site/arm; I am currently breastfeeding... Read more
Soreness at the injection site/arm; Soreness at the injection site/arm; I am currently breastfeeding at time of vaccination; I am currently breastfeeding at time of vaccination; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. This consumer (mother) reported for herself that: a 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ek9231), via an unspecified route of administration in Left arm on 08Jan2021 11:15 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding. There were no Known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination and did not have covid-19 tested post vaccination. The patient was currently breastfeeding at time of vaccination and would continue to do so. The patient experienced soreness at the injection site/arm starting a couple hours after administration on 08Jan2021 13:15 and lasting 1 day. The patient did not receive any treatment for events soreness at the injection site/arm. The outcome of events soreness at the injection site/arm was Recovered in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022052 Same reporter/drug, different patient/event (baby/mother case)
37 2021-01-20 redness, rash macular red flushed on one side of her face; both sides of her face were very red, hot, and blotchy; both si... Read more
red flushed on one side of her face; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; She feels like her skin is burning; right side of face started feeling numb and tingling; right side of face started feeling numb and tingling; Chills; low grade fever; Fatigue; back and body aches; normal body aches/back and body aches; Nausea; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The first vaccine BNT162B2 she received on 18Dec2020. She didn't have any side effects to it. It's lot number was EH9899. Caller just wanted to report her adverse reaction to the COVID 19 vaccine. She got it for work. She got her second vaccine on Thursday. The first vaccine was fine. That Friday she was sick. On 07Jan2021, the patient experienced low grade fever, fatigue, back and body aches, nausea. On 08Jan2021, the patient experienced chills, and normal body aches. On 10Jan2021, the patient experienced right side of face started feeling numb and tingling. This started around her jaw line at 8 o'clock. Then it worked up her face. It was only on the right side. She then monitored it. She went to bed. She woke up at 4 am, and she felt like her face was on fire on an unspecified date. It was tingly. Her face was bright red and blotchy on both sides of her face. She took Benadryl, and put cold compresses on her face. This morning, both sides of her face were very red, hot, and blotchy. She feels like her skin is burning. She feels like she had a burn on her face.It is very odd. There were a couple of days between her reaction and when it started. It has worsened. This morning for work she couldn't put her video on. The outcome of the event low grade fever, back aches, nausea, was recovered on 08Jan2021, fatigue, normal body aches/body aches, chills was recovered on 09Jan2021, the outcome of the events right side of face started feeling numb and tingling was not recovered, while unknown for the other events. Treatment was received for the events "Her face was bright red and blotchy on both sides of her face.", She feels like her skin is burning.
37 2021-01-21 injection site pain I received my 2nd dose of the Pfizer covid-19 vaccine to my left arm on Monday 1-11-21 around 1330. ... Read more
I received my 2nd dose of the Pfizer covid-19 vaccine to my left arm on Monday 1-11-21 around 1330. Following this, I experienced pain at the injection site until 1-12-21 when the pain spread to my left axilla. I also experienced notable swelling to the left axilla and numbness and tingling that radiates down my left arm and into my left pinky and ring fingers. My first dose was also administered to my left arm with only soreness at the injection site experienced. I have not previously experienced any reactions to vaccines in the past.
37 2021-01-21 sensitive skin, itchy skin Light sensitivity, skin sensitivity, flushed skin. My whole body itched.
37 2021-01-21 rash papular, rash with redness On 12/27 feet started feeling like pins sticking in then numbness & cold non stop. This sensation gr... Read more
On 12/27 feet started feeling like pins sticking in then numbness & cold non stop. This sensation gradually moved up to the waistline area. Then total numbness, heaviness in legs, making it difficult to walk. There is also a raised, red rash that burns. Her symptoms are not better.
37 2021-01-22 skin burning sensation 1/7/21: had thee COVID vaccine on 1/5/20 and developed symptoms an hour after administration chills,... Read more
1/7/21: had thee COVID vaccine on 1/5/20 and developed symptoms an hour after administration chills, sweats and bodyaches. Also developed nausea, diarrhea and chest pain. Woke up this morning with cough and congestion. 1/10/21: called this morning to give us an update on her symptoms and see about a COVID swab. states that she is currently hooked up to an IV due to dehydration and no urine output. she has had zofran and pain medication for her severe abd pain. They have strep swabbed and flu swabbed but have not COVID swabbed. Encouraged getting a COVID. She states she will ask them for one and will call us with an update either today or tomorrow. 1/10/21: called and left voicemail stating that she was being discharged. they did COVID 48-72 hours for results. On ABX and Phenergan and Zofran alternating. Got two bags of LR has UTI and Kidney infection. CT with contrast lungs clear. Negative for flu and strep. Strep culture pending. added to spreadsheet since she was COVID tested. 1/14: Called regarding her Covid test. It was reported as negative. is still very sick with fever, sore throat, congestion, nausea. I spoke with Doctor regarding the extent of her symptoms following the vaccine. Doctor recommended that she be seen by her PCP as she has not improved. 1/14: called and went to her PCP as advised by Doctor. now has a UTI and URI. She is on Macrobid and Levoquin as well as Zofran and Phenergan. Her BP was 117/60 and dehydrated. Her PCP told her to monitor her BP and return to ER if not improved and also return to ER if symptoms became worse. will call on Monday 1/18/2020 and update us on her condition 1/17:COVID tests were negative, over 48 hours since a temp above 100.4, 99.1 was the last temp doing better. No more vomiting and no diarrhea. still has a cough and is still on ABX from all of her symptoms. Is on a cough suppressant so recommend her working from home since she is able and will update us towards the end of the week on how she is doing. 1/20: Received the COVID vaccine on 1/5/21. Released yesterday to work from home. No longer has vomiting or diarrhea. COVID, FLU and strep tests negative. Diagnosed with allergic reaction to COVID Vaccine. had kidney infection and UTI. CT of abdomen done with contrast. CXR to r/o pneumonia. continues to have a runny nose, no fever. Continues to have laryngitis and fatigue. called today to get released. Encouraged to call back when she gains more strength and can return. My PCP diagnosed me with a severe allergic reaction to the covid shot. I had the rapid covid test ran twice and the test sent out twice, all 4 tests came back negative. I had the flu test ran and it came back negative. So did the strep culture. I had 2 full lab workups ran and they both came back normal including my vitamin levels. The only thing that was out of alinement was my white cell count was high due to an infection. Today, I am currently running a fever of 99.4. I still have a cough that is rather irritating. I still do not have a voice. I am retaining color back in my skin. I am still tired and weak but have managed to work and do small things around the house such as cook dinner, wash laundry, clean dishes, and shower. These were daily tasks that I wasn't able to do during the first 2 weeks after taking the shot.
37 2021-01-22 injection site pain Injection site pain first 24 hours extending across shoulders and neck to other arm. At about hour 3... Read more
Injection site pain first 24 hours extending across shoulders and neck to other arm. At about hour 38 developed parasthesias of the left arm and complex migraine
37 2021-01-22 redness erythema to face and bilat ears
37 2021-01-23 injection site reaction, hives Urticarial welt around injection site
37 2021-01-24 skin warm, redness 1/23 5:00AM - Woke up with chills, body aches, and a low grade fever. 11:00AM - Fever was at 101. To... Read more
1/23 5:00AM - Woke up with chills, body aches, and a low grade fever. 11:00AM - Fever was at 101. Took Tylenol. 5:15PM - Fever at 103, heart rate 125-145 for about an hour. Took Tylenol and hydrated. 6:15-11:00 - 105-120. 1/24 - heart rate normal, low grade fever, fatigue, and body aches and chills all day. Also noticed pain under my armpit on the side my injection was on. 1/25 - I have had a red bump on my arm since Saturday, but today it is warm and no better than it was on Saturday.
37 2021-01-24 rash, itchy rash, rash papular, rash with redness 6 days post vaccine administration, raised erythematous progressive rash associated with urticaria a... Read more
6 days post vaccine administration, raised erythematous progressive rash associated with urticaria and itch developing on bilateral breasts and lower back but progressing over 5 days
37 2021-01-24 redness, itchy skin Initially she was fine during 15 minutes observation period. Facial redness/itching developed around... Read more
Initially she was fine during 15 minutes observation period. Facial redness/itching developed around 15-20 minutes after shot on 1/7/21. No rash anywhere else on body. Numbness in face. Headache. Per patient, co-nurses told her she had facial swelling. No trouble breathing. No throat swelling. No cough. Got famotidine and Benadryl. blood pressure was elevated (228/120). She felt better after about 2 hours.
37 2021-01-24 bruising, injection site pain Myalgias, fever, injection site pain, rigors (8h - 36h) Fatigue and brain fog (24h-96h) Tender axill... Read more
Myalgias, fever, injection site pain, rigors (8h - 36h) Fatigue and brain fog (24h-96h) Tender axillary adenopathy on injection side (started day 4, resolved by day 8) Tender bruising on both palms (started day 6)
37 2021-01-24 rash macular, hives, itchy skin Patient reported that after dose 1 she was observed due to stated allergies. Approximately 10 minut... Read more
Patient reported that after dose 1 she was observed due to stated allergies. Approximately 10 minutes into this observation she reported tingling around her lips that resolved within approximately 20 minutes. She does not feel she was anxious and hyperventilating when this occurred. She was released and went back to work. Within approximately 30 minutes of being back to work her coworker commented that she had hives on her forehead. These were described as two blotchy areas and were slightly pruritic. They resolved without treatment within approximately one hour.
37 2021-01-24 hives Received vaccine dose #2 1/21/2021 around 3:30pm. Woke up Friday with headache, nausea and progressi... Read more
Received vaccine dose #2 1/21/2021 around 3:30pm. Woke up Friday with headache, nausea and progressive chills and fever throughout the day. By the end of the day was feeling back to baseline. Felt normal all day Saturday and Sunday morning. Sunday afternoon around 1pm left upper lip tingling started and progressed to lip swelling and development of 3 hives to right forearm. Took diphenhydramine, famotidine, ibuprofen and cetirizine at home. Hives did not progress and lip swelling seemed to subside a little. Woke in the night around 3:30am with itching. Eyelids were swollen, hands very swollen with painful palms, new hives to groin, axilla, buttocks. Sought care at ED. No other identifiable cause for reaction, no new food, soap, detergent, exposure etc.
37 2021-01-25 hives Diffuse Urticarial rash, worsening day 3 despite PO dexamethasone, Allegra, Zyrtec and Benedryl. Rec... Read more
Diffuse Urticarial rash, worsening day 3 despite PO dexamethasone, Allegra, Zyrtec and Benedryl. Received IV benedryl due to swollen lips in the ER.
37 2021-01-25 redness Pt. C/O hot flash and dizziness at the time of vaccination then 2 minutes later she developed a migr... Read more
Pt. C/O hot flash and dizziness at the time of vaccination then 2 minutes later she developed a migraine headache at 4:37. She had difficulty walking from her chair to the medical cot due to pain but responded to taking a dose of her own medication of 400mg of Advil and also placing cold packs no her forehead and neck. The pain gradually eased and she was able to leave the clinic at 17:06 feeling better.
37 2021-01-25 injection site redness Pt. developed slight tightness in her chest felt flushed, had some mild erythema at her injection si... Read more
Pt. developed slight tightness in her chest felt flushed, had some mild erythema at her injection site. After medical evaluation, she felt reassured and did not want to use her inhaler, said she would use it later if tightness returned.
37 2021-01-25 rash, itchy skin Rash on stomach; itching all over body; This is a spontaneous report from a non-contactable other he... Read more
Rash on stomach; itching all over body; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3302), intramuscular at right arm on 14Jan2021 11:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included granulomatous mastitis and allergy to Shrimp. The patient's concomitant medications was reported as none (no other medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on stomach and itching all over body on 14Jan2021 11:45. Treatment received included Allegra. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
37 2021-01-25 rash, hives, blister Red welts/hives; blisters; rash started on feet, legs arms and buttocks within 12-20 hrs; nausea; fe... Read more
Red welts/hives; blisters; rash started on feet, legs arms and buttocks within 12-20 hrs; nausea; fever; chills; fatigue; Right foot swollen with blisters; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the second dose of BNT162b2 (lot number: Ek4176), via an unspecified route of administration in left arm on 09Jan2021 15:00 at single dose for covid-19 immunization. Medical history included depression, irritable bowel syndrome (IBS). Concomitant medication included venlafaxine hydrochloride (EFFEXOR), desogestrel, ethinylestradiol (APRI), cetirizine hydrochloride (ZYRTEC), loratadine (CLARITIN), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC) , ibuprofen (MOTRIN). The patient previously took tramadol and cranberry and both experienced allergies. The patient previously received the first dose of BNT162b2 (lot number: Ek5730), at the age of 37-year-old, via an unspecified route of administration in left arm on 20Dec2020 15:00 at single dose for covid-19 immunization. The patient experienced red welts/hives/blisters/rash started on feet, legs arms and buttocks within 12-20 hrs. And nausea, fever, chills, fatigue. Right foot swollen with blisters. The above events were occurred on 10Jan2021 and received the treatments Steroid cream and atarax. The above events resulted in Emergency room/department or urgent care. The outcome of the events were not recovered.
37 2021-01-25 rash macular Severe left knee pain, red splotch marks on left knee. Have not seen doctor, can?t afford to go to E... Read more
Severe left knee pain, red splotch marks on left knee. Have not seen doctor, can?t afford to go to ED
37 2021-01-25 rash macular Swelling and hot spots in Right Hand
37 2021-01-26 injection site pain Adverse events: Pain at injection site, headache, nausea, fatigue, malaise, and chills. Treatment:... Read more
Adverse events: Pain at injection site, headache, nausea, fatigue, malaise, and chills. Treatment: took Tylenol 1 gram by mouth once at bedtime. Outcome: symptoms were alleviated by Tylenol.
37 2021-01-26 rash, itchy skin Systemic: Rash (other than injection site)-Medium, Systemic: Itchiness on extremities and back-Mediu... Read more
Systemic: Rash (other than injection site)-Medium, Systemic: Itchiness on extremities and back-Medium
37 2021-01-26 itchy skin, vaccination site swelling, vaccination site redness itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles);... Read more
itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
37 2021-01-26 injection site pain, injection site swelling pain at injection site - severe-starting 10 hours after lasting 5 days swelling at injection site - ... Read more
pain at injection site - severe-starting 10 hours after lasting 5 days swelling at injection site - starting 10 hours after - lasted 2 days chills- severe- starting 11 hours after lasting 4 hours rigors - severe- starting 11 hours after lasting 4 hours sweats - mild starting 11 hours after lasting 4 hours abdominal cramping - moderate - starting 11 hours after lasting 11 hours Nausea - starting 28 hours after injection - lasting 4 hours
37 2021-01-27 injection site pain 5 minutes post vaccination- in observation location and left hand & forearm starting to feel numb & ... Read more
5 minutes post vaccination- in observation location and left hand & forearm starting to feel numb & tingling - This continued for days and progressively improved about 10 minutes post vaccination - headache sharp, right side. Moved to observation chair for further assessment and vitals check. Upon getting up to go to the new chair, was lightheaded. Vital signs taken and revealed tachycardia and increased BP beyond normal values. Prior symptoms persist. Healthcare workers continue to monitor me while sitting on chair. Oral Tylenol for headache was given. Approximately 30-45 minutes in I feel chest palpitations and an uneasy 'anxious' type of feeling even though I am just sitting down and staying calm. Due to all these symptoms plus the BP and HR remaining high they gave me Benadryl 25mg IM to the right arm as well. The BP started to slowly go down after about 2 hrs as well as HR. Allowed to leave hospital vaccination clinic, while BP and HR still high, was better than the first 2 hours. New symptoms on day 2, pain left arm at injection site and muscles, fatigue and some intermittent nausea. The symptoms continued for 3-4 days post vaccination. I monitored Vitals at home. BP finally stabilized to my normal range around the 4th day.
37 2021-01-27 vaccination site pain Injection site pain; Body aches; This is a spontaneous report from a contactable nurse (reporting fo... Read more
Injection site pain; Body aches; This is a spontaneous report from a contactable nurse (reporting for self). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EL1283, intramuscularly on 09Jan2021 as a single dose (Dose 2), for COVID-19 immunization. Medical history included depression. The patient had not experienced COVD prior to vaccination. The patient had no known allergies. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EK5730 as a single dose (Dose 1) on 09Jan202110:00 right arm, for COVID-19 immunization. There was no other vaccine administered in the 4 weeks prior to the COVI-19 vaccination. There was no reaction with the 1st dose. With the 2nd dose, the patient experienced injection site pain and body aches for 24 hours, onset Jan2021. There was no treatment received for the event. The outcome of the events injection site pain and body aches was recovered in Jan2021.
37 2021-01-27 hives, rash macular, injection site redness, redness PATIENT RECEIVED INITIAL COVID VACCINE YESTERDAY AT NOON. STATES SHE HAD A MILD REACTION WITH ARM R... Read more
PATIENT RECEIVED INITIAL COVID VACCINE YESTERDAY AT NOON. STATES SHE HAD A MILD REACTION WITH ARM REDNESS APPROXIMATELY 30 MINUTES AFTER VACCINE, THEN 3-4 HOURS LATER FACE WAS HOT,RED, BLOTCHY, & TINGLY. APPROXIMATELY 12 HOURS AFTER VACCINE, THE REDNESS SIGNIFICANTLY INCREASED FROM BLOTCHY TO FULL REDNESS, & ALSO HAD HIVES ON NECK, CHEST AND BOTH ARMS, AND THROAT SWELLING STARTED. PATIENT TOOK BENADRYL 50MG AT 3-4 HOURS POST VACCINE AND 25MG AT ~12 HOURS POST VACCINE.
37 2021-01-27 itchy skin Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following ... Read more
Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: Lot: EL3247 Time of Administration: 11:24 Time Symptoms Began: about 10 minutes later _____ Patient alerted observer who took the patient to the medical observation area. I was alerted and responded. She is reporting itching in her throat about 10 minutes after the vaccine was administered. Ears are also itchy. Vaccine given in L arm. Initial Assessment @ _11:55am_: Patient is AAO. The employee is sitting up on the sofa. The employee is pink and does not appear to be in distress. She is talking and making conversation. Vitals @: 11:56am HR:80-90s BP: O2: 97% Pt took Benadryl 25mg PO that she brought with her at 11:58am PMH: - sulfa drugs - hives - Levaquin and these types of meds - rash - food allergies: peanuts, seafood, legumes, tree nuts - environmental allergies such as mold, grass, trees - does take allergy shots Vitals @: 12p HR: 94 BP: -- O2: 98% Vitals @: 12:05p HR: 96 BP: -- O2: 96 Throat does not feel tight but is still itchy. Ears are getting better. Mouth is not itchy, tingly, or weird feeling. Pt does carry an Epi with her. Only used as a child. Has never had to use it as an adult. Medications - Symbicort BID Albuterol PRN Zyrtec - qAM Flonase - qAM Wellbutrin - qday Singulair qPM Vitamins Birth Control 12:08pm - pt is sitting up and talking. No distress noted. We are discussing her work history at Hospital. She has been a nurse at Hospital for 13 years. Previously worked at and is now at Hospital. Vitals @: 12:10p HR: 88 BP: 143/77 O2: 97 Throat is not as itchy at 12:11. O2 is 97-98. Pt reports that this is normal for her. She also notes that the BP is normal for her as well. Patient lives alone but her mom is going to come to her house
37 2021-01-27 rash, injection site rash, injection site pain Rash/Rash extended to chest and down to stomach; Rash and pain at injection site; Rash and pain at i... Read more
Rash/Rash extended to chest and down to stomach; Rash and pain at injection site; Rash and pain at injection site; Significant swelling in armpit with warmth; Significant swelling in armpit with warmth; pain; Swelling of lymph nodes under arm and into chest. All on L arm side where injection was administered; Significant fatigue for 4 days following; This is a spontaneous report from a contactable contactable Other-HCP (patient) . A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 13Jan2021 09:30 AM at SINGLE DOSE for COVID-19 immunization.No pregnant.Medical history included asthma. The patient had COVID prior vaccination .Facility where the most recent COVID-19 vaccine was administered was Living Facility.The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) fexofenadine hydrochloride (ALLEGRA) paracetamol (TYLENOL). On 14Jan2021 16:00 the patient developed Rash and pain at injection site, rash extended to chest and down to stomach, significant swelling in armpit with warmth and pain, swelling of lymph nodes under arm and into chest. All on Left arm side where injection was administered and significant fatigue for 4 days following. The adverse events resulted in: Doctor or other healthcare professional office/clinic visit.No treatment received.The events were assessed as non-serious. The patient had been tested for COVID post vaccination on 17Jan2021 (test type = Nasal Swab Covid test name post vaccination= Rapid). The outcome of the events was recovering Information on lot/batch number has been requested.
37 2021-01-27 vaccination site pain, itchy skin tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; ar... Read more
tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; arm was hurting more than sore/arm pain at injection site; Nausea; Loose stools; Left eye twitching; feeling pretty ill/ under the weather; a little short of breath/shortness of breath; Metal taste in her mouth; Itchy everywhere; asthma has flared up a little bit; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH3246, expiry date unknown), intramuscular (right arm), on 08Jan2021, at single dose, for covid-19 immunization. Medical history included asthma since 2004 (diagnosed about 17 years ago). Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) (has been on this for about 2 months) for asthma. The patient previously took formoterol and budesonide (SYMBICORT) for asthma. The patient stated she was a technician and she has a couple of questions about the Covid vaccine. She got the vaccine on 08Jan2021. Since she got the vaccine, papers said she would feel under the weather for a few days but she was still feeling pretty ill; she wanted to know if this was normal and when should she be concerned, wondering if she should call her doctor. She was encouraged to reach out to her HCP for any medical advice. She also stated that 5-10 min after the vaccine on 08Jan2021, she started to feel a little short of breath/shortness of breath but that resolved. Also, afterwards on 08Jan2021 she had a metal taste in her mouth and was itchy everywhere on that day. She went home and around 9PM on the day of the vaccination, she started to feel under the weather on 08Jan2021. Then she woke up on Saturday 09Jan2021 with headaches, chills, joint pain, sore throat, muscle pain/muscle ache, arm was hurting more than sore/arm pain at injection site, nausea, loose stools, and left eye twitching. On Sunday 10Jan2021, she was very tired and slept most of the day. She added that she has been reporting this to the link that was provided to her. She has been taking Tylenol and ibuprofen to treat these symptoms and; was also using her inhaler because it seemed like asthma has flared up a little bit on Jan2021. No other vaccines administered on the same date with the Pfizer vaccine. The adverse events did not require a visit to the emergency room or physician office. No prior vaccinations within four weeks. The outcome of the events feeling pretty ill/ under the weather, slept most of the day and, asthma has flared up a little bit was unknown. The outcome of events a little short of breath/shortness of breath, metal taste in her mouth, and itchy everywhere was recovered on 08Jan2021. The outcome of joint pain was recovering. The outcome of arm was hurting more than sore/arm pain at injection site was recovered on 13Jan2021. The outcome of the other remaining events was not recovered.
37 2021-01-28 redness After 10 minutes RN walked over to recovery area and noticed that pt's face was red. She asked pt if... Read more
After 10 minutes RN walked over to recovery area and noticed that pt's face was red. She asked pt if she was ok and pt stated yes. RN never left pt side and then noticed her neck getting red and pt c/o ringing in ear. Pt was refusing to stay until she became diaphoretic and the she handed RN EPI pen to administered. RN sat patient down and administered epi to Right thigh. EMS was called patient taken to ED
37 2021-01-28 injection site redness, rash, injection site warmth, cellulitis Approx 1 hour after vaccination of 2nd vaccine, I began having vertigo until noon of that day. head... Read more
Approx 1 hour after vaccination of 2nd vaccine, I began having vertigo until noon of that day. headache persisted multiple days after vaccination. Next day after vaccination I developed systemic edema, rash on legs below knees, migraine, generalized pain, malaise, fatigue. also developed reddened warm area to injection site, dx as cellulitis. Psoriasis areas flared, psoriatic arthritis areas increased in pain. Seen primary care physician after symptoms did not cease on day 6 (Monday) after getting dose 2. Said it was side effect from vaccine and prescribed prednisone taper, doxycycline, and lasix
37 2021-01-28 injection site pain Fever, chills, joint pain, headache, injection site pain, nausea, fatigue.
37 2021-01-28 itchy skin, rash Rash started on neck, spread to chest & face. Small red bumps, itching.
37 2021-01-28 rash angioedema, got steroids ,cetirizine, inhaler, patient refused epi pen, got hydroxyzine. 5 day until... Read more
angioedema, got steroids ,cetirizine, inhaler, patient refused epi pen, got hydroxyzine. 5 day until full resolution of rash and swelling and breathing issues
37 2021-01-28 injection site pain pain on arm/body/body; nausea; brain fog; migraine; swollen arm; pain at injection site; could not m... Read more
pain on arm/body/body; nausea; brain fog; migraine; swollen arm; pain at injection site; could not move; fever; increase blood pressure; chest tightness; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (15Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Pharmacist. A 37-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140, expiration date: Mar2021), via Intramuscular on left arm on 02Jan2021 at 18:00 at 0.3 mL, single for covid-19 immunisation. The relevant medical history was not reported. Concomitant medications were reported as none. The patient previously took Tylenol one hour prior to the vaccination on 02Jan2021 at 1 tablet by mouth. Patient complained of nausea, brain fog on 02Jan2021 at 06:20 pm. Pharmacist recommended to admit ER for safety and to monitor. Patient received the injection at 6pm. Patient was recommended by Pharmacist to admit ER for safety. Patient decided to admit ER at 10 pm. No other symptoms were reported from patient. The patient was admitted to hospital on 02Jan2021 and was discharged on 03Jan2021. While at the hospital, patient informed that she had fever, increased in blood pressure, and chest tightness on 03Jan2021 (reported as mid night). Patient admitted to hospital on 10 pm and was discharged the next day with ibuprofen/Tylenol/ zofran and continue to monitor for symptoms. After discharged, while at home, patient informed about migraine, swollen arm, pain at injection site and body that she could not move at 9:00 am on 04Jan2021. Patient informed that she admitted to hospital again about the pain on arm/body. The patient received 1 dose of 0.3ml and before it was possible that the vaccine was not mixed with sodium chloride prior to administration, an error due to mixture to communicate clearly adequately between our colleagues. Patient received the vaccine at 6 pm on 02Jan2021. After speaking with our colleague about 15 minutes ran to check on the patient if she was feeling okay. Patient complained feeling a bit nausea, brain fog, no other symptoms. Patient stated that she was okay. They stayed back at the store to keep track of patient to admit to ER after her shift at 10 pm. Patient informed she had fever, chest tightness, increase blood pressure at the hospital, then was discharged the next day with ibuprofen/tylenol/Zofran. The following day during at home patient complained at migraine, swollen arm, Pain at the injection site and could not move due to the pain. Patient decided to admit back to hospital for additional information about her pain. They contacted patient again after 3 days, patient informed. She was better and had returned to work on 13Jan2021. The outcome of the events was recovered on 11Jan2021. The pharmacist considered the events were related to suspect product Covid-19 by Pfizer.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported nausea, brain fog, pain on arm/body, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
37 2021-01-28 injection site pruritus within 5 minutes had itching at the site and burning sensation down arm to 4th and 5th digits, becam... Read more
within 5 minutes had itching at the site and burning sensation down arm to 4th and 5th digits, became flushed about neck and face area and was taken to the ED for evaluation by paramedic. Within 20 minutes the adverse mild reaction had subsided without medications and the employee was discharged from the ED.
37 2021-01-29 hives, itchy skin Approximately 8hrs after receiving vaccine I developed itchy eyes, hives around my eyes, itchy throa... Read more
Approximately 8hrs after receiving vaccine I developed itchy eyes, hives around my eyes, itchy throat. I took 2 benadryl capsules. The symptoms resolved in approximately 2 hours. I woke up the next day with some itching and 2 hives on my abdomen (approximately 21 hrs after injection). Nothing was taken and symptoms resolved on their own.
37 2021-01-29 injection site pruritus, itchy skin, rash Itching at injection site after 15 minutes post injection which progressed to itching and rash of t... Read more
Itching at injection site after 15 minutes post injection which progressed to itching and rash of the flanks and neck. She did report itching in her throat. At no time did the individual develop any raised rash (no wheal) or respiratory / cardiac distress. No pulmonary distress or wheezing occurred. Her vital signs remained stable. She responded well to diphenhydramine 25 mg po x one dose and famotadine 20 mg po x one dose. She was observed for 3 + hours while her spouse drove to pick her up as she was advised not to perate a vehicle due to her Benadryl dose.
37 2021-01-29 redness The day after receiving the vaccine, I was extremely fatigued, had fever as high as 102, had a heada... Read more
The day after receiving the vaccine, I was extremely fatigued, had fever as high as 102, had a headache, body aches, chills. 2 days after receiving the arm I got the vaccine in became red and swollen. That lasted 4 days. 5 days after receiving the vaccine I had a low grade fever. Called my Dr about the redness and swelling. She gave antibiotics, but said not to take them unless it grew.
37 2021-01-30 skin mass, skin irritation Development of 6-8 raised, erythematous, and painful nodule-like areas to bilateral axillae with aur... Read more
Development of 6-8 raised, erythematous, and painful nodule-like areas to bilateral axillae with aura-like sensation for 48 hours prior to visible changes noted. Writer/patient had stopped shaving and utilizing antiperspirant immediately once aura-like sensation developed. In addition, joint discomfort and general malaise noted. Writer/patient utilized APAP 1000 mg on 1/20 for pain management at hs. Workplace clinic visit attended on 1/21 with instruction to utilize prescription for triamcinolone 0.1% cream topically BID X10 days with diagnosis provided of ?dermatitis, unspecified ?. Prescription not filled as writer/patient disagreed with plan of care and instead continued to utilize APAP 1000mg Q12 hours x 2 doses for pain management. Presentation/eruption present for 36 hours prior to resolution. (*Per discussion with other healthcare COVID-19 vaccine recipients with similar presentations, writer/patient felt reaction mirrored that of others and chose not to introduce topical steroid). Presentation/eruption present for 36 hours prior to resolution.
37 2021-01-30 itchy skin My scalp became extremely itchy approximately 30-45 minutes after receiving the vaccine. I took bena... Read more
My scalp became extremely itchy approximately 30-45 minutes after receiving the vaccine. I took benadryl as soon as I got home about 90 minutes after receiving the vaccine. Itchiness continued is I took another Benadryl about 3 hours post receiving the vaccine. After 2nd dose of Benadryl, itchiness subsided.
37 2021-01-31 hives ?Pfizer-BioNTech COVID-19 Vaccine EUA? Received second covid vaccine on 1/21 (17 days from first inj... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? Received second covid vaccine on 1/21 (17 days from first injection) and experienced fever, chills, nausea and body aches the following morning. Symptoms resolved by the next morning and pt felt fine all day Sat and Sun morning. Sun after noon around 1pm pt's lips started to swell and developed hives to right arm. This progressed throughout the evening despite antihistamines. At about 4am Monday 1/25 pt awoke with eyelid swelling, persistent lip swelling and more hives and presented to the ED. Pt was given prednisone. Pt followed up with PCP on Tues 1/26 as hives persisted through prednisone. Symptoms have improved over the next few days. No breathing or airway symptoms.
37 2021-01-31 itchy skin Muscle stiffness on left side of neck, left jaw locking, nausea, headaches, fatigue, itching, breat... Read more
Muscle stiffness on left side of neck, left jaw locking, nausea, headaches, fatigue, itching, breathing discomfort
37 2021-01-31 injection site pain Radiating shoulder pain and injection site pain to R shoulder where covid injection was given. The i... Read more
Radiating shoulder pain and injection site pain to R shoulder where covid injection was given. The injection felt very painful and was "high" up on her shoulder. The pain continues and radiates down her arm, especially when lifting and typing. No numbness or tingling.
37 2021-01-31 rash, redness, itchy skin Redness, itching, rash, on wrist where 3M micropore tape was adhered to skin. The tape had been used... Read more
Redness, itching, rash, on wrist where 3M micropore tape was adhered to skin. The tape had been used daily for scar management post-surgery for 4 weeks before vaccine. No reaction to tape adhesive until 1 day after vaccine.
37 2021-01-31 injection site pain SIRVA . Injected incorrectly 1cm below acromin process. 2hrs post injection severe pain (even now),... Read more
SIRVA . Injected incorrectly 1cm below acromin process. 2hrs post injection severe pain (even now), immobility of joint, severe ROM limitation. Unable to perform ADLs. Severe pain
37 2021-02-01 injection site swelling, injection site pain Dose 1: Thursday, January 8, 2021 Swollen throat lymph nodes/Sore arm Dose 2: Friday, January ... Read more
Dose 1: Thursday, January 8, 2021 Swollen throat lymph nodes/Sore arm Dose 2: Friday, January 29, 2021 Day 1 - Sore arm Sunday, Jan. 31 - (NEW) Marble size lump on left clavicle (Swollen, painful - Possible lymphadenopathy) Tuesday, Feb. 2 - (NEW) swollen/painful injection site on left arm Continued marble size lump on left clavicle
37 2021-02-01 rash Facial swelling and temporary paralysis to left side of face started 1/10/21. Swelling lasted two da... Read more
Facial swelling and temporary paralysis to left side of face started 1/10/21. Swelling lasted two days. Facial paralysis 24 hrs, and facial symmetry still not corrected as of 2/2/2021. Entire facial rash started 1/21/2021. Rash started on face and moved down neck and chest. I took Benadryl for three days, which didn?t help. I then started a steroid regimen. 40 mg for three days. 20 mg for three days. I took last dose on Friday, 1/29/21. Rash was resistant to steroid until day three of regimen. Mild shortness of breath occurred 1/23/21, and lasted no more than an hour.
37 2021-02-01 itchy skin Itching all over. Benadryl did not improve the symptoms. Went to urgent care
37 2021-02-01 injection site pain, itchy skin Roughly 45 minutes after receiving dose 2 of the Pfizer vaccine, my face began to feel funny and the... Read more
Roughly 45 minutes after receiving dose 2 of the Pfizer vaccine, my face began to feel funny and then became itchy. This is the same thing that happens when I eat shellfish. It didn't last for more than 45 minutes, and I didn't need to take anything for it. I also woke up in the middle of the night with horrible pain throughout my entire left arm, from my shoulder down through my hand. This lasted a couple hours and then returned to just moderate soreness at the injection site only.
37 2021-02-01 rash Swollen arms & severe rash on arms and back and right hand has numbness & some numbness in left hand
37 2021-02-02 itchy skin, rash 5 days after vaccination, developed a rash on face that eventually spread to neck. Rash feels painfu... Read more
5 days after vaccination, developed a rash on face that eventually spread to neck. Rash feels painful like sunburn and is itchy. Skin is dry and scaly
37 2021-02-02 injection site pain Body aches, dehydration, sniffles, pain at injection site
37 2021-02-02 itchy skin Patient received COVID-19 vaccine on 1/11/2021 at 1538p per vaccine documentation. On 1/11/2021 at ... Read more
Patient received COVID-19 vaccine on 1/11/2021 at 1538p per vaccine documentation. On 1/11/2021 at 1607p, Patient complained of having itching and hand burning. Patient was administered PO Benadryl 50mg at 1607p. At 1617p, patient complained of increased shortness of breath and audible wheezing. Patient was administered Epi 0.3mg IM herself and verbalized relief 2 minutes after Epi was administered. Patient was transferred to Hospital's ER for further evaluation. Patient was prescribed Benadryl 25mg, Pepcid 20mg, Singulair 10mg, and Prednisone 20mg by the ER.
37 2021-02-02 itchy skin itchiness, severe abdominal cramping, diarrhea, chills (about 2 hours after vaccine)
37 2021-02-03 itchy skin, redness 2 hours after receiving vaccine, I became itchy all over body and could not stop. My head, legs, arm... Read more
2 hours after receiving vaccine, I became itchy all over body and could not stop. My head, legs, arms, ears, eyes, up my nose, etc were itchy.; I did not have hives., just redness from scratching non stop; I did not have hives., just redness from scratching non stop; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date unknown) via Intramuscular on 07Jan2021 12:30 PM (vaccine location: Arm Left) at single dose for COVID-19 immunisation. The patient's medical history was reported as Endometreosis, Polycystic ovary (PCOS), anxiety and known allergies to Penicillin. The concomitant medications included duloxetine hydrochloride (CYMBALTA), topiramate (TOPAMAX), Spironolactone, Gabapentin, cetirizine hydrochloride (ZYRTEC), birth control. 2 hours after receiving vaccine on 07Jan2021 02:30 PM, patient became itchy all over body and could not stop. Her head, legs, arms, ears, eyes, up nose, etc were itchy. Patient did not have hives, just redness from scratching non stop, she went home and took Benadryl 50mg, and was still itchy, but not constantly. On 08Jan2021, patient was still itchy all day, but only needed 25 mg of Benadryl to help symptoms and it wasn't nearly as bad as day before. By 09Jan2021, the itching was gone. The outcome of event was recovered on 09Jan2021.
37 2021-02-03 skin warm I felt achy hot chills, lightheaded
37 2021-02-03 hives Patient complained of uticaria with rash on chest and throat
37 2021-02-03 redness Starting morning after immunization, left arm began feeling hard, red, swollen, "feels like there's ... Read more
Starting morning after immunization, left arm began feeling hard, red, swollen, "feels like there's a baseball under my skin". Patient has been taking acetaminophen, ibuprofen, aspirin around the clock, thus is unaware if she has a fever. Patient states she thinks she has cellulitis. Symptoms continue to worsen. Patient will seek medical care tomorrow (2/5/21).
37 2021-02-03 skin warm Woke up feeling horrible achy, hot, chills, nauseas, LIGHTHEADED that faded throughout the day took ... Read more
Woke up feeling horrible achy, hot, chills, nauseas, LIGHTHEADED that faded throughout the day took Tylenol.
37 2021-02-04 rash About 5 minutes after vaccine administration she felt dizzy and developed rash upper chest and upper... Read more
About 5 minutes after vaccine administration she felt dizzy and developed rash upper chest and upper back. BP was elevated 170/105 mmHg RR14 P99 Sat 99% Glucose 130 mg% After sitting in chair with her legs elevated and observed for 1/2 hour BP dropped to 140/80 mmHg, HR 78 and rash resolved
37 2021-02-04 hives HIVES SPREADING THROUGHOUT BODY
37 2021-02-04 vaccination site pain Minor sore arm at injection site; This is a spontaneous report from a contactable consumer (patient)... Read more
Minor sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 20Jan2021 11:45 at single dose for Covid-19 immunization. The patient's medical history included "known allergies: phenothiazine drugs". There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received TDAP vaccine and experienced sore arm at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. On 21Jan2021, the patient experienced minor sore arm at injection site reported as "not nearly as bad as TDAP vaccine". There was no treatment received for the adverse event. The outcome of event is recovering. The patient has not been tested for COVID-19 since the vaccination.
37 2021-02-04 injection site redness, injection site pruritus, injection site swelling Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Inject... Read more
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
37 2021-02-04 vaccination site pain pain at injection site; Ten min after dose my arm felt cold. felt my hands to my cheeks, both hands ... Read more
pain at injection site; Ten min after dose my arm felt cold. felt my hands to my cheeks, both hands felt same temp but injected entire arm felt a cold sensation like my nerves were cold throughout arm; ten min after dose, tingling also like it was colder than the other arm; This is a spontaneous report from a non-contactable Pharmacist (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at 18:00 at single dose in arm for COVID-19 immunisation at the age of 37-year-old. Medical history included anxiety and depression. It was unknown if the patient was pregnant. Concomitant medications were unknown. The patient reported that on 20Jan2021, ten min after dose, arm felt cold; the patient felt her hands to her cheeks (as reported), both hands felt same temp but injected entire arm felt a cold sensation like nerves were cold throughout arm.; tingling also like it was colder than the other arm. It lasted about 30 min, then it got about 50% less intense. Intensity continued till the time of report. The morning of the report on 21Jan2021, the patient woke up with dull pain at injection site. The patient was not treated for the events. The patient did not have COVID prior vaccination, and she was not COVID tested post vaccination. The patient was recovering from the events. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information expected.
37 2021-02-05 pain of skin Fever, chills, body aches and skin pain about 20 hours after vaccination. Still having symptoms toda... Read more
Fever, chills, body aches and skin pain about 20 hours after vaccination. Still having symptoms today 2/6/2021 0700
37 2021-02-05 skin warm The patient felt extremely warm, jittery, her heart was racing, and her face was swelling 10 minutes... Read more
The patient felt extremely warm, jittery, her heart was racing, and her face was swelling 10 minutes after receiving the vaccine. Her face swelled slightly and her arm had shooting pain up and down. The symptoms started with dry mouth and a weird taste in her mouth. That sensation continued for approximately 30 minutes.
37 2021-02-06 injection site redness, hives Muscle soreness and redness at the injection site, general malaise and fatigue, hives (entire body).
37 2021-02-06 hives, itchy skin Within 4 hours hives on torso both front and back appeared. Itchy and covering 75% of body from the ... Read more
Within 4 hours hives on torso both front and back appeared. Itchy and covering 75% of body from the waist up Treatment with Zyrtec about 7 hours after notice of hives. Gone within 8 hours after taking meds
37 2021-02-07 rash It started as a rash all over my back two days post vaccine #1 on 1/9/2021. The rash started to go a... Read more
It started as a rash all over my back two days post vaccine #1 on 1/9/2021. The rash started to go away but never fully did. I received my second vaccine on 1/28/21 and the next day on 1/29/21 the rash increased and spread to the back side of my legs, down my arms and up into my hairline/back of neck.
37 2021-02-07 cellulitis One day after receiving vaccine patient developed cellulitis
37 2021-02-07 itchy skin Patient experienced pruritus and lip tingling approximately 20 minutes after injection. Benadryl 50m... Read more
Patient experienced pruritus and lip tingling approximately 20 minutes after injection. Benadryl 50mg IM administered. Patient's symptoms did not worsen and left on her own.
37 2021-02-07 vaccination site pain Sore arm in injection area; headache; dizzy feeling; extreme chills all night; body aches; fast hear... Read more
Sore arm in injection area; headache; dizzy feeling; extreme chills all night; body aches; fast heart beat; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 21Jan2021 07:30 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital. The patient's medical history was not reported. The patient has no concomitant medications. The patient previously took flexeril [cefixime] and experienced allergies. The patient had no other vaccine in four weeks. On 21Jan2021 17:30 (10 hours after injection), the patient experienced headache, dizzy feeling, extreme chills all night, body aches, fast heart beat. On 21Jan2021 18:00, the patient experienced sore arm in injection area. The patient was not covid tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events headache, dizzy feeling, extreme chills all night, body aches, fast heart beat, sore arm in injection area was recovering. No follow up attempts are possible. No further information is expected.
37 2021-02-07 injection site swelling, injection site warmth, injection site redness arm pain, redness at injection site, swelling at injection site, warmth at injection site, headache,... Read more
arm pain, redness at injection site, swelling at injection site, warmth at injection site, headache, dizziness, nausea, fatigue
37 2021-02-08 itchy skin 1st dose: 01Jan2021/ 2nd dose: 25Jan2021; Angioedema and systemic anaphylaxis; Angioedema and system... Read more
1st dose: 01Jan2021/ 2nd dose: 25Jan2021; Angioedema and systemic anaphylaxis; Angioedema and systemic anaphylaxis; itchy face; Lips swollen; itchy mouth; tongue tingling; This is a spontaneous report from contactable Pharmacists. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318, Exp Date: 31May2021) intramuscular in right arm on 25Jan2021 15:45 at single dose for COVID-19 immunisation. She received the first dose on 01Jan2021 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient experienced angioedema and systemic anaphylaxis on 25Jan2021, events resulted in emergency room/department or urgent care. The signs and symptoms of the anaphylactic reaction were described as itchy face and mouth 20-30 minutes after the vaccination, lips swollen, tongue tingling. Patient was scared and crying. Her lips started to swell. The patient require medical intervention, the patient was seen in the emergency department. It was unknown if the patient hospitalized, the patient was not admitted to an Intensive Care Unit. It was unknown it the patient received treatment. The patient did not receive any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine prior to the event being reported. Events outcome was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-02-08 injection site pain First day: Fatigue Extreme Restless Leg (Advil calmed) Fever (101.4 at highest, Advil, damp washclot... Read more
First day: Fatigue Extreme Restless Leg (Advil calmed) Fever (101.4 at highest, Advil, damp washcloth on forehead) Chills Muscle ache in hips (hot rice pillow, Advil) Pain at injection site 2nd day: Lower fever (99.7, Advil, no damp wash cloth, seemed too cold) Chills Muscle ache in hips and hands (hot rice pillow, Advil) Fluttering under right breast (about 2 seconds long, happened 6 times) Start of migraine (Aleve, took edge off but not completely gone) Pain at injection site Day 3: Migraine (Aleve) Muscle aches in hands (Advil) Late in day, around 2pm, migraine turns into headache in left eye socket by around 7pm pain feels more like congestion in same area. (Aleve, doesn't seem to help much, neither does Advil) Day 4 (Morning): Headache/congested feeling in left eye socket continues (Aleve or Advil, neither help so far)
37 2021-02-08 itchy skin ITCHY EYES, FACE, CHEEK, AND HEADACHE 4/10. WAS GIVEN BENADRYL 50MG BY PROVIDER AND MONITORED FOR 45... Read more
ITCHY EYES, FACE, CHEEK, AND HEADACHE 4/10. WAS GIVEN BENADRYL 50MG BY PROVIDER AND MONITORED FOR 45 MIN WITH NO FURTHER SYMPTOMS.
37 2021-02-08 hives, injection site pruritus Rapid heart rate, blood pressure increase, hives on chest and neck, throat tightness, itching on inj... Read more
Rapid heart rate, blood pressure increase, hives on chest and neck, throat tightness, itching on injection sight, blood pressure drop. This started about 2-3 minutes after receiving the vaccine, I was taken to the back of an ambulance and treated with a shot (I believe it was Benadryl) and oxygen and then transported by ambulance to the local hospital. I was told to continue taking Benadryl and to see my regular doctor. On 02/08/2021 I went to my regular doctor and was put on a steroid (prednisone) and switched to 50mg of Zyrtec twice a day for itching on chest and throat and injection site as well as continued throat tightness.
37 2021-02-08 rash with redness, hives, rash, rash macular he got her 2nd dose of the COVID vaccine at noon today. She did not have a reaction to the first vac... Read more
he got her 2nd dose of the COVID vaccine at noon today. She did not have a reaction to the first vaccine. She has never had a similar rash before. Her rash began on her left hand but has now migrated to encompass her total body. Rash is described as red, blotchy, itchy. No facial or throat swelling, SOB, cough BP (!) 140/95 | Pulse 88 | Temp 99.5 °F (37.5 °C) (Temporal) | Resp 18 | Ht 5' 5" (1.651 m) | Wt 209 lb (94.8 kg) | LMP 01/11/2021 | SpO2 98% | BMI 34.78 kg/m² Physical Exam Constitutional: She appears well-developed and well-nourished. HENT: Head: Normocephalic and atraumatic. Nose: Nose normal. Mouth/Throat: Oropharynx is clear and moist. No oropharyngeal exudate. Skin: Skin is warm and dry. Rash noted. Rash is urticarial. Nursing note and vitals reviewed
37 2021-02-09 itchy skin, rash macular After 30 min post vaccination my hands started itching like crazy - skin was red and blotchy appeara... Read more
After 30 min post vaccination my hands started itching like crazy - skin was red and blotchy appearance but no rashy appearance. Lasted about 2 hours still after medicating myself with antihistamines. About 3 days after the vaccine I noticed a different vaginal discharge that has a different odor, almost like a metallic one. I am not sexually active at the moment but this happened after the vaccine. I have never smelled something like this. It does not smell like an STD odor. I got body aches and severe headaches, congestion and runny nose, I felt terrible, I had a low grade fever (99.1F) I am usually on the 97F range) , general malaise and fatigue, I could not get out of the bed, just to go out to the bathroom. Went to the PCP who tested me for flu and covid and both were negative. The symptoms lasted about 48 to 72 hours. Except the discharge/vaginal odor all symptoms subsided.
37 2021-02-09 injection site redness Facial flushing. HR 72, O2 97%. Slight erythema of L arm injection site. Declined meds. NO SOB, resp... Read more
Facial flushing. HR 72, O2 97%. Slight erythema of L arm injection site. Declined meds. NO SOB, respiratory symptoms.
37 2021-02-09 vaccination site pain Lump nodes swell; Feeling unwell; Nausea; Headaches; Dizziness; Weakness; Injection site pain; This ... Read more
Lump nodes swell; Feeling unwell; Nausea; Headaches; Dizziness; Weakness; Injection site pain; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 24Jan2021 (08:00) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the school/student health clinic. Medical history included asthma. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 24Jan2021 (14:00), the patient had "lump" nodes swelling; was feeling unwell; had nausea; headaches; dizziness; weakness; and injection site pain. The patient did not receive any treatment for the reported events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
37 2021-02-11 injection site warmth, injection site redness, injection site nodule, injection site reaction, hives "Patient reports that just after she was administered the Pfizer COVID-19 vaccine (first dose) on 1/... Read more
"Patient reports that just after she was administered the Pfizer COVID-19 vaccine (first dose) on 1/16/21, she developed redness around the area that resolved in "two to three days". However, she then developed a wheal-like lesion around the injection site in the last day after the initial redness resolved. She noted diffuse warmth around the proximal left upper arm/left deltoid region. She denies tenderness on palpation. She reported feeling a "knot" underneath skin where lesion occurs. She did not complain of SOB/wheezing, swelling."
37 2021-02-14 vaccination site pain 1st dose: fatigue; muscle soreness in neck and shoulders excluding site of injection which was also ... Read more
1st dose: fatigue; muscle soreness in neck and shoulders excluding site of injection which was also sore.; muscle soreness in neck and shoulders excluding site of injection which was also sore.; muscle soreness in neck and shoulders excluding site of injection which was also sore.; This is a spontaneous report from a contactable Other Health Professional reporting for herself A 37 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1686) on 30Dec2020 at 19:00 at single dose intramuscular on right arm for COVID-19 immunization. The patient didn't have medical history. Concomitant medications included ibuprofen MIDOL [IBUPROFEN] and ibuprofen. On an unspecified date after vaccination the patient experienced fatigue and muscle soreness in neck and shoulders excluding site of injection which was also sore. The patient didn't received treatment for the reported events. At the time of the reporting the patient was recovering from the events.
37 2021-02-14 vaccination site pain Soreness at the injection site; This is a spontaneous report from a contactable patient. A 37-year-... Read more
Soreness at the injection site; This is a spontaneous report from a contactable patient. A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 27Jan2021 (at 14:15) at single dose on the left arm for COVID-19 immunisation, administered at a clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have a relevant medical history and concomitant medications. No known allergies. On 28Jan2021, the patient developed soreness at the injection site. Post vaccination COVID-19 test was not performed. No treatment was given for the event. The patient recovered from the event on unknown date in 2021. No follow up attempts are possible. No further information is expected.
37 2021-02-15 rash, hives, itchy rash Chills, drenching sweats, severe muscle and joint pain- started 12 hours after vaccine and continued... Read more
Chills, drenching sweats, severe muscle and joint pain- started 12 hours after vaccine and continued for 48hrs Headache- ongoing for 6 days; Rash (itchy with some hives) on face, arms and shoulders- showed up on day 5 post vaccine and resolved with benadryl; Hot flashes- ongoing for 6 days; Fatigue- severe for 48hrs and moderate ongoing still on day 6 post vaccine; Diarrhea- day 5 has since resolved; Arm pain- moderate for 48hrs and resolved by day 4 Lack of appetite- ongoing for 6 days; Generally I just do not feel good and am surprised many of these side effects have lasted so long.
37 2021-02-15 rash Patient states she had body aches, chills for 2 days. Also had a rash all over her body, low grade f... Read more
Patient states she had body aches, chills for 2 days. Also had a rash all over her body, low grade fever, sore throat, cough and congestion.
37 2021-02-16 itchy skin On Tuesday, February 16, 2021 pt received the Pfizer COVID vaccine (LOT # EN6201, EXP 6/20/21) at ap... Read more
On Tuesday, February 16, 2021 pt received the Pfizer COVID vaccine (LOT # EN6201, EXP 6/20/21) at approximately 2:10pm. Pt approached EMT stating she is "feeling itchy" on her left arm and on her face. Pt said that scratching did not relieve the itchiness she felt. Pt said she received her shot on her right arm however that arm wasn't itchy. EMT did not obverse any signs of distress or indication including hives or redness on skin however pt appeared slightly diaphoretic as she was fanning herself with papers. Pt stated she has never had allergies to any food, medications or vaccine previously. Pt stated she was not experiencing any SOB and upon observation by EMT her breathing appeared unlabored and within normal limits. Pt also stated she felt a bit dizzy after receiving the vaccine. Pt declined a health assessment from EMT at this time and no further vitals were taken. EMT gave 10mL Diphenhydramine HCl oral solution and a water bottle at approximately 2:25pm. Pt stated at approximately 2:30pm she was no longer feeling itchy. Pt said she felt better when she left the vaccine site with a steady gait at 2:45pm-her husband drove her home.
37 2021-02-16 injection site redness, injection site warmth Received COVID vaccine on Saturday 1/2/2021. Originally was about the size of a quarter (was also ho... Read more
Received COVID vaccine on Saturday 1/2/2021. Originally was about the size of a quarter (was also hot and red) but by evening had increased to size of a half dollar. on Monday, Tuesday, and Wednesday the spot was the size of a palm and was bright red and hot. Patient appplied ice and took diphenhyramine thorughout. Her last dose of diphenhydramine was 1/5/2021 evening. She reported on 1/6/2021 since reaction had not resolved. At integumentary exam: Right, Arm, TTP at the inferior aspect of the R deltoid muscle. Unremarkable temperature change of area of concern compared to the other areas of her R arm or to her L arm. Pt had a photo on her phone that showed redness at the deltoid area, where she demarcated it, and compared to today it has significantly improved, and close to her flesh tone. No drainage present or lumps felt. Not erythematous. Pt advised to monitor changes of R deltoid area and note if redness returns, notified that cellulitis was not present at time of exam. Instructed pt to use APAP, ice, and diphenhyramine PRN. 1/29/2021: Pt received 2nd dose of vaccine with no issue.
37 2021-02-17 itchy skin Sweating, itchy back and abdomen, Patient was placed in recumbent position ,was given water and obse... Read more
Sweating, itchy back and abdomen, Patient was placed in recumbent position ,was given water and observed for 17 minutes and was sent home.
37 2021-02-18 itchy rash, rash Itchy little bumps all over, all over body pain, headache
37 2021-02-21 redness, hardening, skin warm Arm with large area of redness, warmth and induration. Started 2-3 days after injection and lasted ... Read more
Arm with large area of redness, warmth and induration. Started 2-3 days after injection and lasted until day 7
37 2021-02-21 itchy skin Patient was observed for 30 minutes following her vaccine and then was dismissed of, symptom free. S... Read more
Patient was observed for 30 minutes following her vaccine and then was dismissed of, symptom free. She then returned after 12 minutes complaining of feeling hot and flushed and throat, face and arms itching. Her O2 sat was 99% on room air, heart rate 71, respiratory rate of 18. She was given Benadryl 50 mg PO and after 10 or 15 minutes stated she did not have any of noted symptoms any longer.
37 2021-02-22 redness 1/7 I started having breast pain. 1/8 I had a fever and chills, breast redness and diagnosed with Ma... Read more
1/7 I started having breast pain. 1/8 I had a fever and chills, breast redness and diagnosed with Mastitis in my right breast. I had severe fatigue and was prescribed a 7 day antibiotics and within 3-4 days I begin to feel back to normal. On 1/8 I had a COVID test which was negative. My breast milk supply went down on the right breast until the mastitis was resolved.
37 2021-02-22 rash Patient reported at 6:40 pm that she had thrown up and was having nausea. EMS attendant was on stan... Read more
Patient reported at 6:40 pm that she had thrown up and was having nausea. EMS attendant was on standby and took vitals: 129/89 BP, Resp 16, lungs clear on auscultation, pulse 104, blood sugar 69. Patient reported she had not eaten since 12:00 pm. Patient reported at 6:50 pm that her nausea was improving. At 7:00 pm, patient had a near-syncope event and was diaphoretic. She was placed in a wheelchair and taken to a private area. She appeared struggling to focus, but was responsive to questions. She developed a rash on her chest and an ambulance was called related to dermal, CNS, and GI symptoms. On ambulance arrival, Diphenydramine 15 mg IV was given and patient was transported to ER.
37 2021-02-22 hives Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident.... Read more
Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident. Pt noted to be slumped in chair, hives noted to forehead, diaphoretic, arms rigid, non-responsive to stimuli, Incontinent of bladder. Pt lowered to ground Zoll applied, COR called. Vital signs: 108/58 100% RA 77 26. Pt given EPI-Pen @ approx. 1352. COR Team arrived, pt mildly responsive. Assisted to Backboard and sent to ER with ED Provider. Pt was monitored in the ED for 3 hours with no recurrent symptoms. Pt advised to follow up with PCP and an allergist and avoid getting the 2nd dose of the covid vaccine.
37 2021-02-23 hives, itchy skin Hives and itching on my arms, hands, ears, neck, stomach and backs of legs. This started 4 days aft... Read more
Hives and itching on my arms, hands, ears, neck, stomach and backs of legs. This started 4 days after my 2nd Covid dose. I am taking Benadryl multiple times a day.
37 2021-02-23 rash Rashes on my left side of body and face for a day and then was gone
37 2021-02-24 skin warm, redness Arm became sore and swollen and warm to the touch. Also on the 4th day showed signs of a reaction, w... Read more
Arm became sore and swollen and warm to the touch. Also on the 4th day showed signs of a reaction, with red patches and appear to mimic the after effects of a bee sting of sorts.
37 2021-02-24 itchy skin Sever upper body itching; This is a spontaneous report from contactable nurse (patient). A 37-year-o... Read more
Sever upper body itching; This is a spontaneous report from contactable nurse (patient). A 37-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital via an unspecified route of administration on 13Jan2021 at 10:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient previously took erythromycin and Polytrim and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe upper body itching on 13Jan2021. The itching started 7 hours after the vaccine. The patient received Benadryl, Zyrtec and Claritin as treatment. The patient recovered from the event. The event was reported as non-serious.
37 2021-02-24 shingles, rash Shingles - rash, pain, discomfort on left torso... back pain 10 days after shot; rash appear around ... Read more
Shingles - rash, pain, discomfort on left torso... back pain 10 days after shot; rash appear around 14 days after
37 2021-02-25 hives Hives and facial swelling approximately 30 minutes after vaccine; went to urgent care; doctor admini... Read more
Hives and facial swelling approximately 30 minutes after vaccine; went to urgent care; doctor administered epinephrine and steroid; started series of benedryl and Pepcid for 48 hours; swelling and hives went away
37 2021-02-26 shingles, injection site pain I first had a typical reaction to the vaccine, including soreness at site, fatigue, aches, and chill... Read more
I first had a typical reaction to the vaccine, including soreness at site, fatigue, aches, and chills. On the fourth day after the shot, I developed shingles on my left side (the same side as where I received the vaccine). It began on the left side of my scalp and progressed down my forehead and to my left eye. My left eye also became very swollen, to the point of being shut. I am 12 days post vaccine now, and I still have shingles and my eye is still very swollen. I have been seen at both the ER and urgent care. I am currently taking Valtrex, oral steroids, and have antibiotic ointment for my eye as well as steroid eye drops.
37 2021-02-26 injection site swelling, injection site pain I noticed achiness on right side of chest about 18 hours after vaccine. This was in addition to ache... Read more
I noticed achiness on right side of chest about 18 hours after vaccine. This was in addition to ache at the injection site. It progressively worsened and grew to up my side/chest to my armpit. It felt swollen and very sore and lasted about 48 hours. I googled the side effect and didn't seek medical attention.
37 2021-02-26 injection site pain Sore arm at site of injection; fatigue 24 hours after injection
37 2021-02-27 injection site pain Fever, chills, body ache, headache, arm- vaccine site pain, cold all day, very shaky
37 2021-02-27 injection site pruritus, injection site mass, injection site redness, injection site pain Red, knot, swollen, itchy, sore circle around injection site about 2 inches wide for the last 3 days
37 2021-02-28 skin tightness Client vaccinated during drive-through event, in a remote, rural setting approx 40 minutes from near... Read more
Client vaccinated during drive-through event, in a remote, rural setting approx 40 minutes from nearest hospital, and instructed to wait 30 min due to past h/o anaphylaxis. At 20 min post-vaccine, she reported feeling "funny," with swelling, tightness, and numbness in her face and inside of her mouth, although "not as bad as last time." Noted to be tachy in the 130's, and making constant mouth movements due to the increasing numbness. After brief explanation, adult Epipen admin to rt thigh. O2 sat remained in upper 90's throughout, and no resp distress was ever noted. BP fluctuated between 96/60 and 142-92 during the course of management. 50mg IM diphenhydramine followed the Epipen, as ambulance was enroute, unknown ETA. With constant monitoring, client reported chest tightness and variable feeing of swelling, tightness, and numbness inside her mouth and face/chin. After 20 min, with some improvement of symptoms, transported by ambulance to ED, where she received continued monitoring and steroid admin. According to ER note, she was released to home after some hours of observation.
37 2021-02-28 itchy skin Generalized itching, advised to take OTC Benadryl-Cleared by EMS
37 2021-02-28 skin spots, vaccination site pain HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migrain... Read more
HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migraine; Left index finger petechiae; had an insect bite; lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile); temperature was 101 F; Acne flare-up; no withdrawal bleeding and she was on oral contraceptive pill (OCP)/withdrawal bleeding 3 days late; woke up at 2:00 AM and 2:35 AM because of the tenderness rolling over and she had to take central analgesia to be able to sleep; puffy face; tenderness at the site of injection; Constipation; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on the left arm, on 06Jan2021 15:45, at single dose, for covid-19 immunization. The patient has no medical history; unknown if there were any allergies. Concomitant medications included oral contraceptive pill (OCP) and multivitamins. The patient had no Covid prior to vaccination. She did not receive any other vaccines within 4 weeks prior to the Covid vaccine. She took pre-vaccination analgesia. The vaccine was given at the hospital. On 06Jan2021 (day 0) she experienced tenderness at the site of injection. She also experienced constipation on 06Jan2021. However, she couldn't "comment" about temperature since she was taking NSAIDs. She woke up at 2:00 AM and 2:35 AM on 07Jan2021 (day 1) because of the tenderness rolling over and she had to take central analgesia to be able to sleep. On 07Jan2021 she experienced tenderness at the site of injection and; puffy face but it wasn't angioedema. Her O2% was "99-98% repositioning" on 07Jan2021. She still had constipation and still couldn't comment about temperature since she was taking NSAIDs. On 08Jan2021 (day 2) she had an acne flare-up; and no withdrawal bleeding and she was on oral contraceptive pill (OCP). For the constipation she started on OTC fiber gum. On 09Jan2021 (day 4) she experienced lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile) which hadn't resolved. She still was experiencing constipation. Her temperature was 101 F on 09Jan2021. On 10Jan2021 (day 5) she had withdrawal bleeding 3 days late and heavier and longer than usual, migraine, constipation, and left index finger petechiae because on "23/11" she had an insect bite on 10Jan2021. On 11Jan2021 (day 6) her lymphadenopathy on the left posterior cervical (1x1 cm tender freely mobile) hasn't resolved; she still had migraine and was now back to regular bowel habit. On 15Jan2021 (day 10) she had HSV 1 "eruption and subli". She received treatment (also reported as symptomatic treatment) for all these adverse events. At the time of the report, she recovered from constipation on 11Jan2021 with lasting effects; while she also recovered from all the other remaining adverse events on Jan2021 with lasting effects. She has not been Covid-tested post-vaccination.
37 2021-02-28 hives, rash, itchy rash Hives; itchy rash on her upper arm of the injection site; rash across her shoulder and both her ches... Read more
Hives; itchy rash on her upper arm of the injection site; rash across her shoulder and both her chest and back and bottom of neck/it spread across her shoulder to right side of her chest, neck and upper right part of her back.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, exp date not reported), via an unspecified route of administration (anatomical location: arm right) on 21Jan2021 10:45 given to protect against the virus (COVID-19 immunisation). Vaccination Facility Type: Hospital. Vaccine was not administered at military facility. Medical history included immediate, severe allergic reaction penicillin when she was a kid and she hadn't had it since. The patient had no other medical history and family medical history relevant to adverse event. The patient's concomitant medications were not reported. Patient had no other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The patient was looking for guidance about getting the second dose of the Pfizer Covid vaccine. Had the first dose on 21Jan2021 (Thursday) and had no reaction until 24Jan2021, 3 days later (Sunday). That night she developed what she believed waas hives, an itchy rash on her upper arm of the injection site that spread across her shoulder and both her chest and back and there was also a rash at the bottom of her neck. The hives were still there the day of reporting and been there since. Patient heard that when you have a severe allergic reaction to medicines in past it could be an indication. States she was not seen at the emergency room or at the doctor's office, she only called the doctor's office. They recommended her not to get the second dose, but she wanted to be sure and wanted more information. Relevant tests were not done. Patient would like to know if she should get the second dose of the covid vaccine after the reaction she experienced post 1st dose. The outcome of events was not recovered (ongoing).
37 2021-02-28 injection site reaction I developed a golf ball sized lymph node under my armpit of the arm that I received my vaccine. I a... Read more
I developed a golf ball sized lymph node under my armpit of the arm that I received my vaccine. I also had swelling in my fingers really bad on the same hand of the arm I got the vaccine. Other side effects were headache, body aches, and a little bit of chills but those were expected. I reached out to my PCP and she said to just monitor it to make sure it goes down in the next few days which I plan to do.
37 2021-02-28 injection site pain Pain at injection site at 6 hours post-vaccination, headache at 12 hrs, nausea, vomiting, diarrhea a... Read more
Pain at injection site at 6 hours post-vaccination, headache at 12 hrs, nausea, vomiting, diarrhea at 24 hrs.
37 2021-02-28 injection site mass, injection site swelling, injection site redness Raised red circular lump at the injection with left arm soreness. Treatment: Tylenol with improveme... Read more
Raised red circular lump at the injection with left arm soreness. Treatment: Tylenol with improvement of soreness. Outcome: Continue to work does not interfere with ADLs. Recommend to use OTC hydrocortisone cream.
37 2021-02-28 vaccination site pain Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fa... Read more
Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) via an unspecified route of administration on 28Dec2020 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hepatitis C. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine, naloxone (SUBOXONE); bupropion (WELLBUTRIN); meloxicam; and lamotrigine (LAMICTAL); all from unknown dates for unspecified indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have allergies to medications, food, or other products. On 28Dec2020 the patient experienced soreness in arm extending beyond the injection site and fatigue for 2 days. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 tests on 28Dec2020, 30Dec2020, 04Jan2021, 08Jan2021, 11Jan2021, 14Jan2021, 19Jan2021, 25Jan2021 with results of negative. The patient did not receive treatment for the events. The events did not cause hospitalization. The outcome of soreness in arm extending beyond injection site was not recovered. The outcome of fatigue was recovered. No follow-up attempts are needed. No further information is expected.
37 2021-02-28 rash papular, rash, rash with redness skin rash in multiple parts of body, arms, inner thighs, behind legs, foot, forearm, shoulder, behin... Read more
skin rash in multiple parts of body, arms, inner thighs, behind legs, foot, forearm, shoulder, behind legs, -rash is red and raised and still present as of today. it does not itch, burn, sting or ooze.
37 2021-02-28 vaccination site pain soreness at injection site; lethargy after the vaccine; headache; This is a spontaneous report from ... Read more
soreness at injection site; lethargy after the vaccine; headache; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medication included loratadine (CLARITIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 16:00, the patient experienced soreness at injection site, lethargy after the vaccine, and headache. The patient received ibuprofen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
37 2021-03-01 itchy skin A few hours after receiving vaccine started to itch on face, scalp, arms, hands, legs, feet. Itching... Read more
A few hours after receiving vaccine started to itch on face, scalp, arms, hands, legs, feet. Itching continued x 3 days. Took 25 mg Benadryl every 6-8 hours x 3 days. Itching gone after 3 days.
37 2021-03-01 shingles Feb 22 started to get some pimples in the left ear Feb 26 started to get some pain in left ear Feb... Read more
Feb 22 started to get some pimples in the left ear Feb 26 started to get some pain in left ear Feb 27 diagnosed as shingles at NYU urgent care .
37 2021-03-01 injection site pain Nausea right after vaccine, burning at sight. Woke up the next morning to extreme Nausea and heada... Read more
Nausea right after vaccine, burning at sight. Woke up the next morning to extreme Nausea and headache. Tylenol and ibuprofen taken but didn't help symptoms.
37 2021-03-01 injection site swelling, injection site redness On 2/17 woke up with 102.3 fever, tongue, lips, eyes swollen, inside mouth/throat irritated, injecti... Read more
On 2/17 woke up with 102.3 fever, tongue, lips, eyes swollen, inside mouth/throat irritated, injection site red and swollen, tingling down left arm extreme fatigue. Increased Blood Pressure and Heart rate
37 2021-03-01 rash, itchy rash c/o itching -rash on both arms. Pt had premedicated with Benadryl. RR called. Benadryl IM adminis... Read more
c/o itching -rash on both arms. Pt had premedicated with Benadryl. RR called. Benadryl IM administered. Itching resolved, rash decreasing. ER precautions given 911 precautions given. Pt dispo home -boyfriend picked up.
37 2021-03-01 rash full body rash occurred 14 days after 2nd dose of COVID vaccine, seen her PCP and diagnosed with" m... Read more
full body rash occurred 14 days after 2nd dose of COVID vaccine, seen her PCP and diagnosed with" medication rash" was given steroid injection and tapering dose of steroids- rash continues
37 2021-03-02 rash, itchy skin, vaccination site rash 5 minutes after receiving the COVID-19 Vaccine shot, she had generalized itching allover her body; H... Read more
5 minutes after receiving the COVID-19 Vaccine shot, she had generalized itching allover her body; Her heart rate was in the 140s/tachycardia; She noticed the COVID-19 Vaccine injection site had a red welt; She developed a rash on her torso first, and then she developed a rash on her neck and face; Shortness of breath; Allergic reaction; Injection site rash; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL8982, expiry: unknown), via an unspecified route of administration in the left arm on 29Jan2021 14:25 at a single dose for COVID-19 immunization at a hospital. Medical history included asthma from 2001. The patient also had history of anaphylactic reactions to bee stings and strawberries. She said her allergist tested her further and told her she has severe allergies to tomatoes and to not eat tomatoes anymore. She said she has allergies to sulfa antibiotics. She said about 10 years ago was the last time she took a sulfa antibiotic and she had hives. She said her allergist recommended she avoid sulfa antibiotics. Concomitant medication included salbutamol sulfate (PROAIR HFA; lot: DAE36A, expiry: May2021; NDC Number: 59310-5779-22) from 2001 and ongoing for asthma. The patient has no prior vaccinations within 4 weeks. The patient received her first COVID-19 vaccine shot on Friday, 29Jan2021, and had an allergic reaction (Jan2021). 5 minutes after receiving the COVID-19 vaccine shot (29Jan2021 14:30), she had generalized itching all over her body, she then had tachycardia. She was administered some medication by the staff at the site where the COVID-19 vaccine was being administered, but her allergic reaction kept progressing. She developed a rash on her torso first, and then she developed a rash on her neck and face. She then developed shortness of breath. She was brought to the hospital's Emergency Room for further treatment. She was given the oral medications Pepcid 40mg, Claritin (dose unknown), and Benadryl 25mg at the location where the COVID-19 vaccines were being administered. When she started to experience shortness of breath, she used her own personal Albuterol inhaler. When she was in the Emergency Room, she was given a shot of Epinephrine .4ml at 15:16, and a dose of Benadryl 25mg IV at 15:10. She was observed in the Emergency Room for a couple of hours and then discharged. The patient was also given a steroid dose pack for her itching, clarified as Medrol 4mg tablets. She said she is titrating down the amount of Medrol 4mg tablets (NDC Number: 59762-4440-2, Lot Number: DM4008, Expiration Date: Oct2022). The patient reported that her itching has improved, but she still has a rash on her torso. She noticed the COVID-19 vaccine injection site had a red welt first on 29Jan2021, clarifying the vaccine injection site has a rash now (2021). She said she was put on a heart monitor when her allergic reaction began to progress, and her heart rate was in the 140s, clarifying she has a heart rate of 145. She said at the time she was discharged from the Emergency Room; her heart rate was 115. She stated she has had to use her Albuterol inhaler throughout the weekend, which is more so than usual, but it is currently allergy season where she lives in. She had no blood work performed while she was being treated in the Emergency Room but did have an EKG to be on the safe side, along with monitoring of her vital signs. The outcome of the events generalized itching, rash, and shortness of breath was recovering; event tachycardia was recovered on 29Jan2021; event vaccination site rash was not recovered while the other events was unknown.
37 2021-03-02 hives, itchy skin Hives, flushing, headache, itchiness began about an hour after administration of the vaccine Tylenol... Read more
Hives, flushing, headache, itchiness began about an hour after administration of the vaccine Tylenol, Famotidine Symptoms began to subside about 20 minutes after administration of medication
37 2021-03-03 itchy skin 30 minutes after shot my throat and tongue started to swell. I took benadryl at that time. 8 hours l... Read more
30 minutes after shot my throat and tongue started to swell. I took benadryl at that time. 8 hours later I became very itchy and my face swelled (including lips)
37 2021-03-03 injection site pain Received the second vaccine on 2/10/21 and just yesterday (3/3/21- 3 weeks after my second dose) sta... Read more
Received the second vaccine on 2/10/21 and just yesterday (3/3/21- 3 weeks after my second dose) started having pain/soreness at the injection site like I had immediately after the first and second doses. Unsure why the pain came back. My skin looks fine- no redness or raised from what I can tell.
37 2021-03-03 skin warm arm automatically felt heavy and hot. immediately started coughing. then after that I started feelin... Read more
arm automatically felt heavy and hot. immediately started coughing. then after that I started feeling tight in my chest and airways. I waited and it progressively got worse. it felt like I had phlegm stuck in my throat that I could not get out. nurses at the drive offered to call 911 but I was close enough to an Urgent care/ER that I decided to drive myself over there. they took me in, started an IV and gave me 50mg of epinephrine and Benadryl, steroids and Pepcid. they prescribed an EpiPen. They told me to continue taking Benadryl because the allergic reaction could resurface. cough is still present and I have body aches.
37 2021-03-03 hives multiple instances of heart rate over 140 and a top heart rate of 155 hives - daily since injection ... Read more
multiple instances of heart rate over 140 and a top heart rate of 155 hives - daily since injection psoriasis outbreak - first time in 4 years
37 2021-03-03 itchy skin patient states had small reaction to Gardasil vaccine with numbness and tingling, wanted to continue... Read more
patient states had small reaction to Gardasil vaccine with numbness and tingling, wanted to continue with covid 19 vaccine. she had vaccine and immediately after receiving vaccine stated with itching and tingling. Gave her 50mg Benadryl and still having numbness and tingling and states " Throat was closing up. Gave epi-pen and symptoms improved then transported to ER.
37 2021-03-04 injection site pain Chest tightness/pain, acid reflux, gas, throat discomfort, fever, injection site soreness, headache,... Read more
Chest tightness/pain, acid reflux, gas, throat discomfort, fever, injection site soreness, headache, fatigue, extreme nausea, and body aches.
37 2021-03-04 hives, itchy skin, rash with redness Hives all over body. Started as red bumps like big bites and then turned into hives 2 days later. Ve... Read more
Hives all over body. Started as red bumps like big bites and then turned into hives 2 days later. Very itchy and uncomfortable. Went to a dermatologist and she gave me a steroid to clear it up. Never had hives or any other skin condition prior.
37 2021-03-04 itchy skin Pfizer-BioNTech COVID- 19 Vaccine EUA: During post-vaccination observation period, vaccine recipient... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: During post-vaccination observation period, vaccine recipient developed localized swelling and itchiness. They were monitored by EMS and took their own diphenhydramine.
37 2021-03-04 hives Swelling/hives on left arm, left hand, and right hand. Tingling/swelling lips and lump in throat.
37 2021-03-04 rash with redness Within minutes I had pin prick red dots on my right arm. We were at a drive through clinic waiting t... Read more
Within minutes I had pin prick red dots on my right arm. We were at a drive through clinic waiting the 15 minutes in the parking lot before leaving and had the paramedic from the ambulance come look. I leaned into the seat to let my husband photograph my dots, and where my shoulder was leaning into the seat, I immediately had a smattering of red pin prick dots. They began showing on my left arm. We were advised to go to the ER. My hemoglobin was fine (though clotting factors were off), and he?d see a few reactions like that, so we were sent home. I had diarrhea, abdominal pain, and severe nausea, but nothing scary or bad. I woke to not being able to urinate, and that was followed with complete incontinence. I cannot control my bladder at all, cannot urinate on demand, and often don?t realize I?m urinating until I feel the warm gush.
37 2021-03-04 injection site pain Woke up with horribly sore arm where shot was given, also mild sore throat, also headache and sore m... Read more
Woke up with horribly sore arm where shot was given, also mild sore throat, also headache and sore muscles throughout my body that aren?t improving with pain meds
37 2021-03-05 itchy skin Flushing, swelling of upper left lip. Itchiness on face, brain fog. BP 150/105 (pulse 119). Final BP... Read more
Flushing, swelling of upper left lip. Itchiness on face, brain fog. BP 150/105 (pulse 119). Final BP 129/97 (pulse 93).
37 2021-03-05 rash macular, injection site pain, rash, skin warm Numbness to right side of cheek/lip Rash to bilateral hands/arms/abdomen/legs/back/chest Arm injecti... Read more
Numbness to right side of cheek/lip Rash to bilateral hands/arms/abdomen/legs/back/chest Arm injection pain. Mottling to skin all over Warmth radiating up my arm to my face where it?s numb Body aches
37 2021-03-05 injection site mass, injection site redness, injection site warmth Redness on R arm, felt like there was a "lump", warm to touch, evaluated by EMS, advised Benadryl. C... Read more
Redness on R arm, felt like there was a "lump", warm to touch, evaluated by EMS, advised Benadryl. Cleared
37 2021-03-06 redness, itchy skin 02/26/2021-after 4hr ;redness. severe itchy, allergic reaction through the body /took a benadryl 02... Read more
02/26/2021-after 4hr ;redness. severe itchy, allergic reaction through the body /took a benadryl 02/27/2021 -visit Dr. recommend take a Zyrtec/ redness, severe itchy, allergic reaction through the body 03/01/2021- visit Dr. took a shot of steroid/ after no redness no itchy 03/03/2021 -until now hand and foot itchy in the morning
37 2021-03-06 hives Late Friday night - developed hives in trunk area. Saturday-Sunday: Hives slowly spread to limbs. ... Read more
Late Friday night - developed hives in trunk area. Saturday-Sunday: Hives slowly spread to limbs. Periodic usage of Benadryl 2 times a day (late afternoon and night) reduced the bumps, itchiness and redness to some extent. Would return and spread more by morning.
37 2021-03-06 rash Rash all over neck, torso and arms
37 2021-03-07 injection site pain 01/29/2021 Fatigue, soreness at injection site. Pt took OTC Tylenol/Advil. 02/18/2021 Epigastric pai... Read more
01/29/2021 Fatigue, soreness at injection site. Pt took OTC Tylenol/Advil. 02/18/2021 Epigastric pain, dyspnea, nausea, vomiting. Pt took OTC Tylenol/Advil and went to Dr. office because pt thought she had gallbladder pain/concern. 02/20/2021 Pt went to ED: tested negative for Covid-19 virus but found to have elevated liver enzymes. Pt remained at hospital inpatient status until 02/24/2021. Pt states she was never given any diagnoses/causes for symptoms. 03/05/2021 Pt went to her PCP, and blood labs obtained; pt continues to have elevated liver enzymes per pt's report.
37 2021-03-07 itchy skin, rash While in observation, patient reported being very hot and itchy. Rash on chest, neck and arms. Com... Read more
While in observation, patient reported being very hot and itchy. Rash on chest, neck and arms. Complaining of throat feeling a little tight prior to going to ED. While in Ed, given famotidine, solumedrol, and Benadryl. Prescribed EpiPen, famotidine and prednisone at discharge. Patient states she has rash on chest, neck and arms after 1st vaccine and was given Benadryl and steroid shot.
37 2021-03-07 injection site pain Within 12-14 hours from receiving the 1st dose of the vaccine, I began to have symptoms that initial... Read more
Within 12-14 hours from receiving the 1st dose of the vaccine, I began to have symptoms that initially started as general malaise, fatigue, and muscle and aches and pains. By 2am On 2/09/21, I began having chills and by 6am, I had a fever of 101. F. Pain at the injection site started to develop , which I understood is a normal side effect of vaccines in general, but then over the course of hours to days, the pain began to radiate up my arm to my shoulder, and up my neck, to my head where a severe headache would ensue and render me unable to perform my daily activities. For days I was feeling unwell causing me to call out sick from my job as a nurse more than once. I also feel pain in my axilla and breast tissue adjacent to my arm pit, directly beneath the injection site. I also experienced nausea when the headache and muscle aches were at their worst. The fever eventually subsided after a few days, but the headache has persisted despite taking Ibuprofen as directed by my physician via a telehealth visit on day 3. (I called for an appointment on day 2, but they only had the next day available.) The headache pain is heavy, sharp, piercing, and throbbing, definitely interrupting with my daily activities. I have to go lay down and apply an ice pack to my head and neck area several times a day. These symptoms had been persisting for several days in a row and after being seen by my doctor again on the 8th day because of the symptoms, she recommended I go to the emergency room to address the persisting headaches and rule out any head bleeding and report the symptoms related to the vaccine. I was also advised by my physician to consider skipping the 2nd dose of the vaccine because of my severe reaction to the first one.
37 2021-03-08 injection site pain I had local injection site soreness - resolved after a day or two. I just noticed I had muscle aches... Read more
I had local injection site soreness - resolved after a day or two. I just noticed I had muscle aches - seemed local to both thighs. I told my OB in a regular prescheduled checkup. It bothered me more than my belly did. Ached when I walked and when I got up and out of a chair - had to grab on to the chair or when I went up or down the the steps - had to hold the rail. I was close to full term. It resolved about the week after and I delivered shortly after that, too. I didn't miss work because of the adverse symptoms as it was my last day of work anyway. Estimated due date: February 7, 2021; delivered January 31st; Birth weight - 7 lbs 5 oz. 1st pregnancy - vaginal delivery. No complications during pregnancy. After delivery I had high blood pressure which was new. I think it's getting better - I'm trying to wean off the high blood pressure medication at this time.
37 2021-03-08 injection site bleeding It was administered really high in the arm, I started bleeding right away, no other pain at the time... Read more
It was administered really high in the arm, I started bleeding right away, no other pain at the time really. In the middle of the night I woke up in extreme pain, I couldn't lift my shoulder or move without being in so much pain. The first dose was a normal pain but this one I couldn't move my shoulder. This lasted days with extreme pain. I am still having issues with range of motion in my arm, certain ways I move my arm still causes pain but not extreme. I did a virtual visit on the next day after the 2nd dose and he prescribed a mild pain medication and recommended if it wasn't better in a week to come in and see someone. The pain didn't get better so I went in to see someone. The did an xray and nothing was wrong. and didn't know what exactly was going on and said it was varsities. He recommended doing cortisone injections but I opted out.
37 2021-03-08 itchy skin Patient stated to Lead RN that she was feeling "itchy" on her arms and legs and that scratching did ... Read more
Patient stated to Lead RN that she was feeling "itchy" on her arms and legs and that scratching did not relieve the itchiness after receiving her second dose of Pfizer vaccine. She stated it was the same reaction she felt as the first dose. EMT & Lead RN did not obverse any signs of distress or indication including hives or redness on skin. Patient stated she was not experiencing any SOB and upon observation by EMT Lead RN her breathing appeared unlabored and within normal limits. Lead RN authorized EMT to give 50mL Diphenhydramine HCl oral solution per protocol and a water bottle at approximately 2:15pm. Patient stated at approximately 2:30pm she was no longer feeling itchy. Lead RN &EMT educated patient regarding s/sxs of adverse reaction and when to go to the ED/call MD.
37 2021-03-08 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA Sore arm - started an hour later until 3/9 around 2pm Injection... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Sore arm - started an hour later until 3/9 around 2pm Injection site soreness - started about an hour later and has continued Fatigue - started about 10pm on 3/7 until around 11pm on 3/8 Body aches - started about 10pm on 3/7 until 12pm on 3/9 Headache - started about 10pm on 3/7 until 12pm on 3/9 Swollen lymph nodes on left side, behind hear and throat - started about 10pm on 3/7 until 2pm on 3/9 Sore throat on left left - started about 10pm on 3/7 and has continued
37 2021-03-08 itchy skin, redness itching and redness on face, neck, and arm on the same side of body where vaccine was administered o... Read more
itching and redness on face, neck, and arm on the same side of body where vaccine was administered occurred approximately 2 hours after administration.
37 2021-03-08 shingles, rash started getting rash on left torso under arm on 3/3 then noticed vesicles on 3/6 in distribution of ... Read more
started getting rash on left torso under arm on 3/3 then noticed vesicles on 3/6 in distribution of shingles
37 2021-03-09 itchy skin, redness, hives, injection site pruritus, injection site redness Localized itching and erythema at the site of injection with onset of hives on the upper arm spreadi... Read more
Localized itching and erythema at the site of injection with onset of hives on the upper arm spreading downward.
37 2021-03-09 rash Patient reported swelling of arm and feeling dizzy. She laid on the ground and became panicked. Wi... Read more
Patient reported swelling of arm and feeling dizzy. She laid on the ground and became panicked. Within a couple of minutes she started getting red blotches that could be seen on her chest and neck area and started to flush. She was given benadryl. Symptoms resolved after several minutes.
37 2021-03-09 itchy skin Pt reported itching 26 mins after vaccine. Evaluated by EMT and itching resolved.
37 2021-03-09 redness The left side of my face swelled a bit, became red and numb. By the next day, the redness and swell... Read more
The left side of my face swelled a bit, became red and numb. By the next day, the redness and swelling has mostly disappeared, but the numbness is still there. I can feel it in my ear, my eye, my teeth, lips, and whole left side of my face just aches.
37 2021-03-10 itchy rash, redness, pain of skin, rash, skin swelling 2 hours after injection got extremely tired and had rashes similar to that of a scalding water burn ... Read more
2 hours after injection got extremely tired and had rashes similar to that of a scalding water burn on the tops my feet. They are circular in shape and the skin between my toes hurt. The rash covers the majority of the tops of my feet. They are itchy. I have almost slept since 8pm last night and it is now 3:15 the following afternoon. My husband had difficulty waking me up. I have been extremely foggy and jumbleing my words each time I wake up and when I try to text I dont realize I'm typing words that do not make sense. I also have the normal symptoms like headache and sore arm. Tops of my hands seem puffy and red. Extreme thirst and hunger.
37 2021-03-10 itchy skin, hives, rash Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingl... Read more
Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingling lips and shaking. EMS was on scene at clinic immediately removed me from car and checked vitals, BP was high 176/94, took by ambulance to ER at Medical Center. Treated in ER for 4.5 hours. Developed migraine, received benadryl, steriods,and medicine for the migraine. Sent home told take benadryl for 2 days and do
37 2021-03-10 itchy skin Called for physician response to covid vaccine reaction. The following signs/symptoms were observed:... Read more
Called for physician response to covid vaccine reaction. The following signs/symptoms were observed: itching Heart Rate: 92, 90 BP: 147/91, 138/87 Treatment administered: zyrtec 10 ml SL at 18:45 Response to treatment: Itching improved within a few minutes Disposition : discharge to home at 19:09 - instructed to return to ED / call 911 if worsening of symptoms
37 2021-03-10 rash Sever Skin Rash all over the body
37 2021-03-11 hardening, itchy skin, redness 10 minutes after vaccination the entire left hand side of my face went numb as if I'd had a dental p... Read more
10 minutes after vaccination the entire left hand side of my face went numb as if I'd had a dental procedure (I was injected on the left side). The nurses on site looked me over and said I was ok to go home at the end of my wait time. The effect faded as the day went on and was gone the next morning. I was vaccinated on a Tuesday morning and on the following Thursday morning I woke up with swelling covering almost my entire bicep area on the side I was vaccinated. The area is about 8 inches by 4 inches. It is swollen, red, hard to the touch, painful and mildly itchy. As of today (Friday) it has gotten a couple of inches bigger and not improved at all.
37 2021-03-11 skin warm After 60 minutes from receiving the first shot my face became flush and hot like a bad sunburn. Thi... Read more
After 60 minutes from receiving the first shot my face became flush and hot like a bad sunburn. This only showed on my cheeks and a little on my forehead in color and felt hot to touch. The rest of my face being warm but not with the red coloring. The flush coloring faded after 4 hours and my face felt less hot but still warm. I didn't take anything but water and some food. A bad headache was included in this feeling and now my face feels and looks closer to normal after 9 hours. I did not run any fever and I did feel that laying down was the only thing to do. Yet while resting, lights flashed from my right side to the center (when looking into the darkness) which was very new and different. I only mention this as I have no clue how that could be related but I've never experienced this...
37 2021-03-11 injection site bruising, injection site pain, bruising Day of vaccine (Tues 3/9): Mild headache, injection site soreness. I can't tell if it's related, bu... Read more
Day of vaccine (Tues 3/9): Mild headache, injection site soreness. I can't tell if it's related, but I couldn't really focus on work-related tasks - I don't know if it was just the nervousness of waiting for side effects or what. Day after vaccine (Wed 3/10): Mild headache that came and went through the day (I took acetaminophen in the early evening), tiredness, injection site soreness (noticed bruise forming), and felt "off" - not quite nauseated, but not normal self. Same lack of focus/productivity. Two days after vaccine (Thur 3/11): No headache, injection site soreness waning (but bruise is bigger), not as tired, better focus, but in the evening, I felt a hard rounded node above my collarbone (about two fingers wide). Freaked out, Googled it, saw swollen lymph nodes on side of vaccine site is somewhat typical. Appears to be my left supraclavicular lymph node and if you look hard enough, you can visibly see the left side is slightly swollen. I cannot feel any other swollen lymph nodes. Today (Fri 3/12): Bruised injection site, and this swollen, hard lymph node is quite sore. Other than that, I feel fine at the moment.
37 2021-03-12 itchy skin Full body itch, treated with Benadryl ten minutes post vaccination. Stomach cramps, 4 hour post vacc... Read more
Full body itch, treated with Benadryl ten minutes post vaccination. Stomach cramps, 4 hour post vaccine. Fever, chills, muscle aches
37 2021-03-13 injection site rash, injection site warmth, injection site pruritus, injection site redness The next day my arm was very sore. I got a painful, red, itchy rash at the injection site. It was... Read more
The next day my arm was very sore. I got a painful, red, itchy rash at the injection site. It was also very hot to the touch. Today is Sunday and it?s pretty much better. Still a little sore but the rash is mainly gone and it?s no longer hot. Other than the rash I got a headache, tiredness, and muscle aches on the following day after injection 03/10 but those only lasted that day.
37 2021-03-13 injection site pain Two days after receiving my second dose, I awoke to the most intense dizziness and spinning I have e... Read more
Two days after receiving my second dose, I awoke to the most intense dizziness and spinning I have ever experienced, accompanied by nausea. The rapid spinning subsided, but I am unable to remain upright without dizziness and nausea returning. I have thrown up a little, but mostly have just heaved. I have a headache as well. Other side effects have been soreness at injection site and heavy fatigue the day after the second dose. I
37 2021-03-14 itchy skin Severe and sporadic itching of entire body 3 days post vaccine which has continued for over a week n... Read more
Severe and sporadic itching of entire body 3 days post vaccine which has continued for over a week now (8 days to be exact). Small rash will sometimes appear however after a few hours will go away. Benadryl will sometimes help however the itching is not getting better on its own. Predominately located on all 4 limbs, neck and chest. Itching is worse towards end of the day, especially at night and for short durations throughout remainder of the day. Itching to the point of breaking skin to relieve and even then it continues. I have increased water intake and have to take benadryl at night to even get some rest however once the benadryl wears off it comes back and almost worse.
37 2021-03-14 vaccination site pain Soreness for 48hrs at vaccination site; This is a spontaneous report received from a contactable nur... Read more
Soreness for 48hrs at vaccination site; This is a spontaneous report received from a contactable nurse (patient). A 37-year-old female non pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: EL3247), via an unspecified route of administration on left arm on 04Feb2021 12:30 at single dose for COVID-19 immunisation at workplace clinic. The patient medical history included known allergies with Sulfa drugs and Dust mites. The patient concomitant medications included daily multivitamin (unspecified) received within two weeks of vaccination. The patient was not received other vaccine in four weeks. On 04Feb2021 18:00, the patient experienced soreness for 48hrs at vaccination site. No treatment was received for the event. The patient not had COVID prior vaccination. The patient not tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date in 2021.
37 2021-03-15 blister, rash, injection site rash, injection site pruritus 2 nd dose Covid19 vaccine , Pfizer on 3/11 at 3 pm She start feeling sick on 3/12 at 3 am : fever... Read more
2 nd dose Covid19 vaccine , Pfizer on 3/11 at 3 pm She start feeling sick on 3/12 at 3 am : fever up to 103 F , cold sweats , body aches , she was in bed for 2 days This morning fever is 102 F Since yesterday - sore throat and blisters in her mouth and lips, feeling fatigue like running 1 mile No cough , no shortness of breath , no dyspnea of exertion Fine dry rash on face ( not itchy) and at the side of injection ( itchy) + nausea, no vomiting Appetite is fine No diarrhea Taking over the counter - Tylenol
37 2021-03-15 hives Hives on arms and chest
37 2021-03-15 redness, rash, itchy skin Swelling, intense itching and redness on face particularly around eyes and eyelids, cheeks, neck and... Read more
Swelling, intense itching and redness on face particularly around eyes and eyelids, cheeks, neck and back of ears. Also present in and around the bellybutton and on both arms (strong on right arm). Started day after injection and continued to intensify despite doses of benedryl and loratadine, and topical cortisone. Morning of 3/16 woke up to slight swelling in throat and overall intensified swelling in face and neck.
37 2021-03-15 hives Two hours you noticed swelling but I didn't think much of it. I started feeling a little weird and p... Read more
Two hours you noticed swelling but I didn't think much of it. I started feeling a little weird and pain in the arm. About 01:00, I woke up and I was in a lot of pain. I had hives all over me. Hives were spreading all over my body: hair; arm with the injection; we called 9-1-1 I went to the hospital. They gave me some meds through IV. By that time, I had taken Bendryl and I was there about 4 hours with IV. I felt better but hives didn't subside. That Sunday afternoon they started getting worse again and I went back to the hospital (16th)and they gave me rounds of something through IV. On 17th, I went back to hospital - they gave me another shot for the hives. I worked on the 18th - but was they said I should go home because I didn't look well. My lip started swelling that night. On the 19th, I went to my doctor and the Dr, used an epi-pen on me and gave me a shot of something for the welts still on my body. They still didn't go away. Symptoms have calmed down - but I still have spots on me. I am on Prilosec and anti-itch - Atarax and some others.
37 2021-03-16 rash, itchy skin Client stated got Pfizer Vaccine dose 1 on 2/24/21 and reported diffused itching and rash over body ... Read more
Client stated got Pfizer Vaccine dose 1 on 2/24/21 and reported diffused itching and rash over body 1.5hrs after receiving vaccine. Did not take any medication or report to provider. Symptoms resolved after 3 days.
37 2021-03-16 shingles Got shingles.
37 2021-03-16 itchy skin, hives Hives and itching that began on right arm and has since spread to left arm. Taking Benadryl and hydr... Read more
Hives and itching that began on right arm and has since spread to left arm. Taking Benadryl and hydrocortisone cream otc.
37 2021-03-16 rash macular On Wednesday, March 17, 2021 client received her first dose of Pfizer COVID vaccine (LOT # ER2613, E... Read more
On Wednesday, March 17, 2021 client received her first dose of Pfizer COVID vaccine (LOT # ER2613, EXP 7/2021) at approximately 2:55pm. Client waited in Observation Area and was observed by EMT to have blotchiness in both hands 15 minutes later. Client also stated to EMT her "throat feels tight and dry." EMT alerted Lead RN while EMT took vitals at 3:25pm. Vitals: BP: 110/80, HR: 125 bpm, O2 sat: 96%. Upon assessment of client, Lead RN authorized EMT to administer 50mg of Diphenhydramine HCL oral solution per protocol with a water bottle at 3:36pm. Another set of vitals were taken following administration of Diphenhydramine HCL oral solution. Vitals at 3:38pm: HR: 78 bpm, O2 sat: 97%. Final set of vitals were taken at 3:46pm: BP: 118/86, HR: 71 bpm, O2 sat: 96%. Client stated the initial throat tightness with dry throat and mouth subsided after administration of Diphenhydramine HCL oral solution. At 3:50pm client was educated by Lead RN & EMTs on s/sx of adverse reaction and when to go to the ED/call MD. Client left vaccine site with a steady gait at approximately 3:52pm.
37 2021-03-16 redness, skin warm red circle feels swollen hard underneath, warm to touch
37 2021-03-17 injection site pain Moderate to severe arm pain (numbness, tingling, radiating, heavy feeling, sensitive to touch throu... Read more
Moderate to severe arm pain (numbness, tingling, radiating, heavy feeling, sensitive to touch throughout arm, muscle soreness, muscle weakness), headache, fatigue, fever. Began about 30 mins after injection to 3 days after receiving injection. Site tenderness currently.
37 2021-03-17 rash with redness, rash, shingles On Sunday March 14th, I woke up with pain in my upper left back. The next day, small clusters of red... Read more
On Sunday March 14th, I woke up with pain in my upper left back. The next day, small clusters of red bumps started to form on my chest and under my left armpit. The rash spread to my back the following day. On Wednesday, March 17th, I went to urgent care and was diagnosed with shingles. I've never had shingles before. I'm currently on a 7-day treatment of valacyclovir.
37 2021-03-17 rash with redness Two days after receiving the vaccine, red rash localized to inner elbows and neck area began. On day... Read more
Two days after receiving the vaccine, red rash localized to inner elbows and neck area began. On day 3 after vaccine, a rash started on face and hands and worked its way all over the top half of her body. Patient took Benadryl at home, and then went to the ED, where she received Pepcid and prednisone. The rash went away after 1-2 hours following the medication administration.
37 2021-03-17 injection site pain injection site pain tiredness ? headache ? muscle pain ? chills 13 hrs post injection ? joint pain ... Read more
injection site pain tiredness ? headache ? muscle pain ? chills 13 hrs post injection ? joint pain same as above ? fever same as above ? nausea, vomiting, temperature 103.1 same as above ? feeling unwell same as above
37 2021-03-17 hives, redness pt. developed hives to the Lt. arm & redness to the chest. Medics present. Pt. denies any difficul... Read more
pt. developed hives to the Lt. arm & redness to the chest. Medics present. Pt. denies any difficulty swallowing &/or other S/S. Administered Benadryl 50mg PO at 1635. pt. waiting as vaccination site an additional 15 mins to be monitored (45mins total). pt. having someone else drive her home BP: 127/78. HR: 79, RR:16.
37 2021-03-18 rash, itchy skin Itching, numb tongue and throat within hour after vaccine. Diarrhea within two hours. Rash on cheeks... Read more
Itching, numb tongue and throat within hour after vaccine. Diarrhea within two hours. Rash on cheeks three days later.
37 2021-03-20 injection site tingling, injection site numbness Patient was instructed to remain in store for at least 15 minutes after vaccination to monitor for a... Read more
Patient was instructed to remain in store for at least 15 minutes after vaccination to monitor for any adverse effects. She c/o tingling and numbness from shoulder to her fingers on the left arm (vaccine site) approximately 10-15 minutes after vaccine was administered. Symptoms persisted approx. 30 minutes after vaccine. Patient reported symptoms had improved and decided to leave the store; she smiled and waved before leaving pharmacy.
37 2021-03-20 rash with redness, rash Reviewed shot 3/18/21 at 5:00 pm. Next day fever, headache, sore arm. On March 21 woke with all over... Read more
Reviewed shot 3/18/21 at 5:00 pm. Next day fever, headache, sore arm. On March 21 woke with all over body red rash. Still running fever and sore throat.
37 2021-03-20 injection site pain Severe Delayed arm pain (5 days later) at site of injection
37 2021-03-21 redness First Pfizer vaccination shot given at 11am, felt fine until 9pm that night then sudden onset dizzy,... Read more
First Pfizer vaccination shot given at 11am, felt fine until 9pm that night then sudden onset dizzy, lips tingling, then cheeks swelled and got very red, low grade fever 99.7F. Took 50mg benadryl within 10 mins of initial symptoms and another 25mg an hour later after talking to the oncall doctor.
37 2021-03-21 vaccination site rash Nausea and Vomiting: vomitted twice evening of 03/21/2021, still feeling nauseaus on 03/22/2021 at 2... Read more
Nausea and Vomiting: vomitted twice evening of 03/21/2021, still feeling nauseaus on 03/22/2021 at 2:30pm Headache: took tylenol for that, still dealing with the headache almost 24 hours later Dizziness: subsisided on it's own around 10pm last night Increased heart rate: went from 70 to 145 in one minutes at 5:47pm, went back down to normal heart rate around 6:30pm on 03/21/2021 Mild rash at vaccination site: did not take any medication, but disappeared this morning at 6:30am
37 2021-03-21 hives Patient has experienced worsening generalized urticaria and arthralgias, fatigue 48 hours after her ... Read more
Patient has experienced worsening generalized urticaria and arthralgias, fatigue 48 hours after her vaccination. This is a chronic longstanding issue for her already but has worsened, and patient is unsure if she should get the second dose of pfizer. She did not experience any anaphylaxis symptoms.
37 2021-03-22 hives Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue... Read more
Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue, dizzy light-headed, loss of voice, sob, diarrhea, and sore arm. No outcome still ongoing testing and seeing specialists.
37 2021-03-22 injection site pain Onset of extreme pain in vaccinated arm about 2-3 hours after vaccine, and worsening until the follo... Read more
Onset of extreme pain in vaccinated arm about 2-3 hours after vaccine, and worsening until the following day. Had radiating pain in arm in the elbow and down to the fingers which felt like extreme tendinitis. Could not lift my arm more than a few inches without excruciating pain. The following day, the radiating pain subsided, but I still had severe muscle pain around the vaccination and could only lift my arm to shoulder level. On day 3, most of the pain was finally gone.
37 2021-03-22 itchy rash, rash Rash on both ears, spread to behind ears and neck. Rash is itchy and burns.
37 2021-03-22 hair loss States she continues to lose her hair several weeks after first dose of vaccine.
37 2021-03-24 injection site redness, injection site hardening, redness My left underarm area is swollen and feels soft. The same consistency as a water balloon. There is ... Read more
My left underarm area is swollen and feels soft. The same consistency as a water balloon. There is some redness in my armpit as well. And the vaccination site is reddish and feels tougher than the rest of my arm or my right arm.
37 2021-03-24 rash, hives On 3/25/21 at 1220 Pt received her first Pfzier vaccine to the left deltoid and was sitting in the p... Read more
On 3/25/21 at 1220 Pt received her first Pfzier vaccine to the left deltoid and was sitting in the post vaccine observation site under 15 min observation. Pt was witnessed slumping down in chair by nurse at 1225 and then became unconscious with eyes gazed and to the right with snoring respirations. Pt was assisted to the floor by two nurses without any trauma lying supine and legs elevated. VS were taken 122/60,59,20 and SPO2 87%. Pt woke while BP was being taken and started talking and was A&OX4. Pt was placed on oxygen at 10LPM with NRB mask. SPO2 increased to 99%, pt's skins were W/D with good color. Pt denied any SOB, itchy throat or difficulty swallowing, rash or hives. Pt was feeling a bit better and oxygen was taken off. Pt was then sat up with legs straight while on the floor to repeat VS at 1231 Pt's BP was 70 systolic, pluse of 58, SPO2 dropped again to 87% and pt became vere dizzy and vision blackening and was layed back down immediately with legs elevated and NRB mask at 10 LPM was placed back on with increased SPO2 of 99%. Pt had positive orthostates. Pt also c/o tingling hands. 911 was contacted at 1234. VS at 1241 were 106/60, 62, 20 and SPO2 of 100%. Pt's husband was at her side. 1247 engine co 54 arrived onscene and report was given to paramedic. AMR unit 460 arrived approx 2 min later. Pt was assessed and transported to closest ER.
37 2021-03-24 hives Sever outbreak of Hives all over the body.
37 2021-03-26 hives Broke in a severe case of hives all over my body (scalp down to legs).
37 2021-03-26 rash Rash began on right hand (shot administered on left shoulder). First noticed around 8am. Rash began ... Read more
Rash began on right hand (shot administered on left shoulder). First noticed around 8am. Rash began spreading to right forearm and left hand. Took 2 benadryl around 12pm. By 6pm, rash was on both hands/wrist, both forearms, right upper arm, and a few spots on my neck. Took 2 benadryl at 7:00pm and 2 benadryl at 11:00pm.
37 2021-03-26 rash Started with lethargy and hot flashes, followed by extreme shortness of breath, difficulty speaking ... Read more
Started with lethargy and hot flashes, followed by extreme shortness of breath, difficulty speaking and holding up my head and keeping my eyes open. Then trembling. The local nurse at the vaccination sight reported high blood pressure, rapid pulse and seemingly extremely low blood sugar. I didn?t go to the ER because my supervisor agreed to take me home since we were volunteering at the sight prior to me receiving the vaccine. I had to keep eating every hour or so due to blood sugar seeming very low. Shortness of breath continued. Pulse rate still high as I could sleep with my head down due to racing pulse in my head. Later that night I had small bumps on my arms with no itch. Then I had extreme fatigue and muscle fatigue. I kept experiencing extreme episodes of hot flashes. I woke up in the middle of the night with a headache and uncomfortable hot flashes. I drank 100% juice and ate a few goldfish. I had mild nausea and food aversions. The next day the bumps were gone. I went to work but was sent home. I was told I should have gone to the ER but I don?t have insurance. Once home, I went through 5 hours of extreme chills unlike anything I have ever experienced. I had to cross my arms over my chest and stack on blankets to regulate. If I moved my arms for more than five minutes or pulled the blanket down, I began uncontrollably trembling. I still had trouble regulating my blood sugar on day two. It?s day three and no bumps and no chills. Less muscle fatigue as well. I am still pretty exhausted and tire easy when doing things. I did experience the common soreness in the muscle the vaccination was administered, but I figure that is normal. I am hopeful that I am improving and out of the danger zone. I took Garden of Life Elderberry with added nutrients last night and today I took my normal detox probiotic. I have been pushing fluids and have broken my intermittent fasting to try and keep my blood sugar up. I feel like my system is finally regulating and now I just have lingering exhaustion from the events that took place.
37 2021-03-28 itchy skin Left pinky finger began to get itchy at about 13 minutes. A couple minutes later my scalp was itchy.... Read more
Left pinky finger began to get itchy at about 13 minutes. A couple minutes later my scalp was itchy. I alerted staff then. Then my chest and back became itchy. At about 18 minutes after the shot I started having trouble breathing, my throat felt like it was closing and I had a terrible cough. Given two Epi shots about 10 minutes apart, ER gave me breathing treatments and other meds via an IV and shots (I don't know what, I was a little out of it).
37 2021-03-28 injection site pain, injection site swelling Pain and swollen right arm where shot was given. Metal taste in mouth that has not gone away yet. Ta... Read more
Pain and swollen right arm where shot was given. Metal taste in mouth that has not gone away yet. Taste like a coin is in mouth. Started between 30- 1 hour after shot and still tasting it a day later
37 2021-03-30 rash Dizziness, blurred vision, extreme aches, joint aches, difficulty walking, nausea, fever, chills, th... Read more
Dizziness, blurred vision, extreme aches, joint aches, difficulty walking, nausea, fever, chills, throw up, rash all over body, difficulty breathing, migraine
37 2021-04-03 skin burning sensation After a few minutes, I started to feel chest pains which started to intensify, then my breathing sta... Read more
After a few minutes, I started to feel chest pains which started to intensify, then my breathing started to get shallow. Next, I was feeling tingling in my extremities. Then like the flick of a switch, I went into anaphylactic shock. I couldn't breathe and struggled to get the words out to get an epi pen. I was then injected with 3 epi pens while the ambulance was called. I also felt tingling in my tongue and mouth. The following day at home, I had another reaction. It started with tingling in my throat then the shallow breathing again. Chest pains again, then anaphylactic shock again. The next day, allergy symptoms came back, but not anaphylactic shock. This time, the addition of burning in my biceps on both sides, which traveled down to my forearms. Later on, the burning traveled down my torso to my legs. There is also some burning in my ears and scalp. My breathing is shallow, and it seems like when the allergy meds start to wear off, the symptoms keep coming back. They're happening now as I write this
37 2021-04-10 hives I first got a bad headache and dizzy. They brought me back behind a curtain with an emergency person... Read more
I first got a bad headache and dizzy. They brought me back behind a curtain with an emergency person. I got very dizzy and nauseous after that. They had me lay down on a cot. About 30 minutes after I received the vaccine, they brought me out to my husband?s vehicle in a wheelchair. By that time, I was so dizzy that I could hardly stand by myself. I was told to call my primary care doctor. My husband called them while we were headed home. My tongue was swollen a little. We decided to go to my father in law?s home, since he is a doctor. By the time we got there, I was coughing. We were still on hold for a nurse at my primary care doctor?s office. I started getting hives on my chest and neck and wheezing around the same time. We left before seeing my father in law to go home and use my nebulizer. For the moment, I used my inhaler, which doesn?t work as well. Once we got to my driveway, a nurse from my PCP office said to go straight to the emergency room. I spent the night at the hospital that night and was treated for an allergic reaction, which resolved the issues. I continued medications at home after leaving the hospital the following day.
37 2021-04-11 skin warm, rash my arm has a big bump it is hot to the touch and painful. It started as 2 bumps that looked like a b... Read more
my arm has a big bump it is hot to the touch and painful. It started as 2 bumps that looked like a bee sting or bite. Then by Saturday 4/10/21 it was one big bump. I believe it is called the covid arm.
37 2021-04-17 rash Dizziness; blurred vision; joint aches; extreme pain; difficulty breathing; fever; chills; sweats; l... Read more
Dizziness; blurred vision; joint aches; extreme pain; difficulty breathing; fever; chills; sweats; large rash; This is a spontaneous report from a contactable consumer. A non-pregnant 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 21Mar2021 at 15:30 (Batch/Lot Number: EN 62v3) at 37-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient's medical history included gluten allergy from an unknown date and unknown if ongoing, COVID-19 prior to vaccination from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 28Feb2021 (Lot Number: EN6201, administration time 15:30, location: Left arm, dose number: 1). On 22Mar2021 02:00, the patient experienced: dizziness, blurred vision, joint aches, extreme pain, difficulty breathing, fever, chills, sweats, large rash; all of which required a visit to a doctor or other healthcare professional office/clinic, emergency room/department or urgent care and hospitalization. The patient was hospitalized for all of the events for 1 day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Mar2021. Therapeutic measures were taken as a result of the events, which included intravenous (IV) fluids and pain medications. The clinical outcome of the events was recovered with sequelae on an unspecified date. Follow-up attempts have been completed and no further information is expected.
37 2021-04-17 skin burning sensation anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheez... Read more
anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheezing; Throat closed; chest tightened; burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning; Scalp and ears also burning; ears also burning; Itchy throat all days; couldn't breath or talk; This is a spontaneous report from contactable consumers. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 13:30 (Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included fish, tree nuts, peanuts allergy, in-door & outdoor environmental allergies, pet dander allergy, rheumatoid arthritis, asthma, GERD, chronic dry eye and ADHD; all from an unknown date and unknown if ongoing. Concomitant medications included albuterol, lifitegrast (XIIDRA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), prednisone, cetirizine hydrochloride (ZYRTEC) and etanercept (ENBREL); all taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021 13:45, the patient began with chest pains, then tingling in extremities, then shortness of breath & wheezing. Suddenly, was in anaphylactic shock. The patient experienced throat closed, chest tightened, couldn't breath or talk. Same symptoms came back on 01Apr2021. The patient went to emergency room/department or urgent care. The patient stated, "I went into anaphylactic shock again and back to hospital. The following day, anaphylaxis re-turned, but no anaphylactic shock. Shortness of breath, burning in arms that traveled down my arms then into my torso and legs. Itchy throat all days. Scalp and ears also burning. Today, on day 4, still feeling the burning and trouble breathing. Every time the Benadryl wears off, it feels like it's still attacking my body". Treatment for the events was received such as 3 epi-pen injections, EKG, IV of Benadryl and IV of steroids. The outcome of the event "burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning" was unknown and the outcome of the rest of the events was not recovered. The patient was hospitalized due to event anaphylactic shock that was also reported as life threatening.
37 2021-04-20 injection site pain Sore at injection site a week after vaccine administered
37 2021-04-28 redness Clotting; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it... Read more
Clotting; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunisation. Medical history included allergies and asthma. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for allergies. The patient previously received first dose of BNT162B2 on 17Feb2021 for COVID-19 immunisation; and experienced thrombophlebitis and leg swelled up and got very sore, painful, and red (lot number: EL9266 at 04:00 PM). About 2 weeks after the first dose, patient's leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis. She received the second dose on 10Mar, and her leg got worse a few days later. She visited the emergency room and was sent to a specialist who put her on blood thinners for clotting. Patient stated that the only significant change or occurrence in her life was that she received the vaccine. The events resulted to a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the event clotting was unknown, while not recovered for the other events. Information on the lot/batch number has been requested.
37 2021-05-04 injection site swelling 24 hours after vaccine: chills, headache, muscle aches, fatigue, symptoms resolved within 8hrs of on... Read more
24 hours after vaccine: chills, headache, muscle aches, fatigue, symptoms resolved within 8hrs of onset. 48 hours after vaccine localized swelling at injection site continuing for 3+ days
37 2021-05-04 hives Severe Hives; Severe swelling on eye and lip; Severe swelling on eye and lip; severe swelling arthri... Read more
Severe Hives; Severe swelling on eye and lip; Severe swelling on eye and lip; severe swelling arthritic feeling in hands; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ENS318) via unspecified route administered in Arm Left on 26Jan2021 09:30 via an unspecified route of administration, as single dose for an unspecified indication. Historical vaccine included first dose of bnt162b2. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D COLECALCIFEROL). No other medication taken four weeks prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test with unknown date. The patient experienced severe hives on, severe swelling on eye, severe swelling on lip, Started roughly 10 hours after the vaccine and are still lasting 4 days later. Also severe swelling arthritic feeling in hands(could not grip anything on day 2) all these on 26Jan2021 19:00. The patient was currently using prednisone, Zyrtec, benedryl, and Pepcid AC and said nothing was helping. The patient said she had no known allergies and have never had hives before. She had to miss two days of work. The outcome of the event was not resolved. Follow-up (02Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Query: Dear Manufacturer, Kindly see the attached document received by Pfizer Inc. containing a product in which you have been identified as the manufacturer. Response: Email received. Case created #. Dear Colleagues, Would you kindly address the query below and copy it to the mailbox with your reply.
37 2021-05-12 shingles developed shingles. It began on my scalp and then traveled down my forehead and into my eye; develop... Read more
developed shingles. It began on my scalp and then traveled down my forehead and into my eye; developed shingles. It began on my scalp and then traveled down my forehead and into my eye; My eye became so swollen, it shut completely; fatigue; aches/ soreness; chills; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9267) dose 1, via an unspecified route of administration, administered on the left arm on 15Feb2021 05:00 AM as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 (prior vaccination), ulcerative Colitis and known allergies red food coloring. Concomitant medications included infliximab (INFLECTRA), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); zinc and ergocalciferol (VITAMIN D). Upon receiving the vaccine, the patient initially had a typical reaction including soreness, fatigue, aches, and chills (Feb2021). On 19Feb2021 07:00 AM, patient developed shingles. It began on her scalp and then traveled down her forehead and into her eye. This was all on the left side of her scalp and face (the vaccine was given on my left side). Her eye became so swollen, it shut completely. She visited both the ER and urgent care as well as an ophthalmologist. She is now 12 days post vaccine and she still have shingles and extreme swelling of left eye. Currently taking Valtrex, oral steroids, steroid eyedrops, and using antibiotic ointment on her eye. The events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events which included Valtrex, steroids, antibacterial ointment. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events fatigue, aches/ soreness and chills was unknown and not recovered for the other events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event Ophthalmic Herpes zoster with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
38 2020-12-31 injection site swelling, injection site warmth, injection site redness Injection site had developed redness, elevation and warm to touch 8 days after vaccination was given... Read more
Injection site had developed redness, elevation and warm to touch 8 days after vaccination was given. Topical benadryl applied to site to lessen redness..
38 2020-12-31 injection site pain Significant increase in pain and tenderness of right arm where I had fallen/broken my radial head at... Read more
Significant increase in pain and tenderness of right arm where I had fallen/broken my radial head at the olecranon. Also worsening of hip pain on the right where i have chronic hip pain.
38 2021-01-01 itchy rash, rash I broke out in a face rash. It started at my chin and went up my jaw lines. Was dry and itchy. No lo... Read more
I broke out in a face rash. It started at my chin and went up my jaw lines. Was dry and itchy. No lotion or creams I tried work. It finally went away on its own in about a week.
38 2021-01-01 injection site pain, injection site pruritus Pain and itching at injection site after about 2-4 hours lasted to the next day approximately 24 hrs... Read more
Pain and itching at injection site after about 2-4 hours lasted to the next day approximately 24 hrs Face flushing started about 2-4 hours after vaccine and lasted only about 4 hours. Nausea started about 6 hours after vaccine and lasted about 10 hours
38 2021-01-01 injection site pain delayed intermittent ache in L upper arm/shoulder/neck area.
38 2021-01-03 injection site swelling, injection site redness, injection site pain, injection site pruritus 40 mins after receiving the vaccine the right side of my throat, ear, forehead and arm went numb. T... Read more
40 mins after receiving the vaccine the right side of my throat, ear, forehead and arm went numb. The right site of my body started tingling. Burning , red, swollen and itching at the injecting site.. Area around injection site was the size of a softball very painful, itchy, burning sensation, swollen, and red. I took Benadryl
38 2021-01-03 hives Hives noted on chest. Took 25mg po benedryl and hives were resolved within 3 hours.
38 2021-01-04 injection site rash, injection site redness In first few days after vaccination experienced arm pain, headaches and body aches. All symptoms su... Read more
In first few days after vaccination experienced arm pain, headaches and body aches. All symptoms subsided by day 7. On day 10 (12.31) began to again experience arm pain and new rash over injection site. Pain spread to opposite arm and then became generalized. Pain worse in armpits. Rash turned into raised bullseye over injection site prompting MD visit. COVID tested completed and was negative blood work sent and is pending. I was started on Pepcid/benedrly and doxycycline.
38 2021-01-04 injection site pain It was extremely painful when I received the vaccine and I immediately felt my fingers tingling. In ... Read more
It was extremely painful when I received the vaccine and I immediately felt my fingers tingling. In about 10 min I felt very hot in my face, back and felt like I was going to pass out. My heart was racing, it was about 130. My BP initially was 139 and then 160 after that. I never passed out but I felt those waves with a tingling to my face and my neck as I was going to pass out and I started shaking and my heart was racing and my BP was up and it lasted about 45 min before it started going down. They gave me some Ibuprofen at the Employee health and they kept observing me and it started getting better after 45 min. I still felt the waves of feeling flush and hot and cold and very fatigued.
38 2021-01-04 injection site swelling, injection site pain, injection site warmth Mild headache starting on Saturday evening around 7:00pm, January 2nd, took 3 ibuprofen, Sunday morn... Read more
Mild headache starting on Saturday evening around 7:00pm, January 2nd, took 3 ibuprofen, Sunday morning, January 3rd, woke up around 10-11am body aches, headache, fatigue, swollen lymph node under left arm pit, took 3 ibuprofen around 12:00pm. Headache and body aches subsided slightly but never fully gone. Around 6:00pm -7:00 low grade fever and chills, took 3 ibuprofen around 8:00pm. Body aches and fatigue continued to Monday, January 4th, but was reduced in severity, took 3 ibuprofen around 10:00am. All symptoms with exception of swollen lymph node and heat/swelling/pain at injection site are now gone by Tuesday January 5th.
38 2021-01-04 injection site pain Nausea, bloating, gas, and pain at the injection site. Nausea set in 3 hours after injection and las... Read more
Nausea, bloating, gas, and pain at the injection site. Nausea set in 3 hours after injection and lasted about 36 hours. Bloating and gas continue day 3. Pain set in 10 hours after injection and lasted 24 hours. No medical attention needed, tea, soup, fluids, moving the arm, and rest helped.
38 2021-01-04 rash macular, itchy skin, rash papular, rash with redness Nervous; I had two new spot on my knee; I had another one on my shoulder and on my lower back/I am g... Read more
Nervous; I had two new spot on my knee; I had another one on my shoulder and on my lower back/I am getting one may be on my ear like I said they pop up and they itch a little; Red patchy hives and itchy waves of red rashes all over the body; raised red rash on my left hip; Red patchy hives and itchy waves of red rashes all over the body; raised red rash on my left hip; Red patchy hives and itchy waves of red rashes all over the body; raised red rash on my left hip; This is a spontaneous report from a Pfizer-sponsored program. A contactable 38-year-old female Nurse (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: 31Mar2021) at single dose since 22Dec2020. Relevant history and concomitant drug was none. The patient excepted Covid 19 vaccine could decrease the chance of contacting Covid 19 virus, while she stated she was getting a red patchy hives and itchy waves of red rashes all over the body just after received the vaccine. The patient (nurse) stated, "I would if I can explain a little more, the day after I received the Covid vaccine I had noticed a big like what I would explain it like a red hives, like a raised red rash on my left hip it last like a day its subsided and next morning I woke up and I had a different flares that was the same on my other side of my body again went away. After a day when I woke up and I had two new spot on my knee that was the other thing, those went away on that day. This morning I woke up and I had another one on my shoulder and on my lower back. I am also thinking I am getting one may be on my ear like I said they pop up and they itch a little and they go away. I never ever experienced anything like it and I see the only thing that I have changed in my life or regimen or added to my body so I just wanted to make sure it was reported. I am nervous and curious if it is a potential side effect added if I should be careful before getting second one all those things." No treatment was received for the events. Outcome of events was unknown. When probed for the Causality, the nurse stated, "I have no idea, if it is something going on with me that is completely unrelated its just occurred right after I got the vaccine so I have no idea if this is a separate issue or not. I going to see dermatologist and physician but until then I just thought to report it to you all to see if anybody is experiencing this and to know if it is safe to go for second dose."
38 2021-01-04 itchy rash itchy rash; This is a spontaneous report from a contactable nurse (patient). A 38-years-old female p... Read more
itchy rash; This is a spontaneous report from a contactable nurse (patient). A 38-years-old female patient received the first dose of bnt162b2 (Pfizer BioNTech, Solution for injection, lot number: EK5730), via an unspecified route of administration on the left arm on 22Dec2020 17:45 at a single dose for immunization. Medical history was reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. On 28Dec2020 at 06:00, 6 days after the initial Covid vaccine dose, the patient developed an itchy rash all over her body. Started first thing in the morning with itchy ankles, and by the afternoon, it was covering her whole body in patches and was intensely itchy. No other associated symptoms. No new detergent, clothing, foods, meds to explain. The patient left for work, showered, and took Benadryl. The rash went away and at the time of the report, feels fine. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. The patient has no other vaccine in four weeks. The events resolved on an unspecified date in Dec2020.
38 2021-01-04 hives urticaria generalized and involving soft palate
38 2021-01-05 hives 20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it ... Read more
20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it was tingling, patient felt flushed and warm and stated she "just didn't feel right" patient evaluated by provider - claritin 20mg given, vitals taken after another 30 minutes of being observed patient stated she"felt better"-hives gone
38 2021-01-05 itchy skin About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, ... Read more
About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, I began experiencing mild itching on my face, chest and upper body (no hives or rash) and my face was flush. At about 40 minutes, began experiencing nasal congestion, runny nose and and a slight tickle in the back of my throat. A few hours later, all symptoms resolved.
38 2021-01-05 injection site pain Fatigue and injection site soreness. Narrative: Patient awakened this AM with injection site sorene... Read more
Fatigue and injection site soreness. Narrative: Patient awakened this AM with injection site soreness and fatigue. She did not come to work today stating she felt too tired
38 2021-01-05 injection site tingling, injection site numbness Numbness and tingling on the injection site and the left side of your face. Also reports a metallic ... Read more
Numbness and tingling on the injection site and the left side of your face. Also reports a metallic taste in her mouth
38 2021-01-05 redness Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localize... Read more
Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localized reaction of tenderness and slight redness. No other symptoms. Provider was placed in the observation area and given and ice pack for the area and made aware that we do have oral Benadryl available. After about 2-3 min Genoveva alerted me that she was now having some itching/scratchiness to the back of her throat and requested Benadryl. 25 mg PO with water was administered and she was immediately escorted to the ED for evaluation with an RN, per protocol.
38 2021-01-05 vaccination site swelling Right arm Swollen and tender lymph node; Right arm Swollen and tender lymph node; This is a spontane... Read more
Right arm Swollen and tender lymph node; Right arm Swollen and tender lymph node; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular at the right arm on 28Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included psoriasis, psoriatic arthritis, chronic back pain and childhood asthma. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient known allergies was tramadol. On 29Dec2020, the patient experienced right arm swollen and tender lymph node. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
38 2021-01-05 vaccination site pain Shortness of breath; Sore arm like she got kicked in the arm by a horse. Her arm felt like this toda... Read more
Shortness of breath; Sore arm like she got kicked in the arm by a horse. Her arm felt like this today.; Chest pain; Headache; Body aches; Fever; Chills; fatigued; feels cold; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (lot number: EL3246), via an unspecified route of administration, at deltoid right, on 30Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included chronic asthma from an unspecified date, stomach surgery a year and a half ago, sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has had asthma stuff since she was very young. Is relatively healthy. No family medical history. No relevant tests. The patient's concomitant medications were not reported. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations within 4 weeks. The patient previously took flu vaccine on 01Oct2020 and experienced fatigued, tired, and sore arm like she got kicked in the arm by a horse. It was reported that received COVID-19 vaccine yesterday (30Dec2020). Been having some chest pain. Started a couple hours after receiving the COVID-19 Vaccine. Chest pain doesn't whole heartedly go away. Gets more intense and then relaxes. Wants to know if this is common or something she just has to deal with. Doesn't know if this is stomach pain. Had stomach surgery a year and a half ago. Sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has been taking heartburn and gas medications. Chest pain is not going away. Wants to know if this is common. Tried to look online and only found common side effects. Her husband looked it up and two people died from a heart attach after receiving the COVID-19 Vaccine. She is getting older, but is not that old. Caller works in behavioral health. Had an instant headache. Clarified chest pain: Is always lingering in the background. Doesn't fully go away. Comes and goes in waves. Gets intense and relaxes. Chest pain was pretty sharp this morning and it made her short of breath. Doesn't know if it was the pain that took her breath away. Occurred at 10:00. Indication: Has older people she takes care of. Her mother is super frail and has dementia. Her uncle is elderly and has heart issues. Wants to do her part so she doesn't catch it. No further details provided. In regards to the two people who had heart attacks and died after COVID-19 Vaccine, caller has no patient identifiers or NDC/Lot/Exp to provide. Stated this people were in the UK and the information was just something her husband read on the internet. Also experienced body aches, fever, and chills between 14:30 and 15:00 yesterday, 30Dec2020. Is super fatigued. Doesn't know if she is febrile, hasn't checked temperature. Still feels cold and has chills today. Does not have a headache today. It was also reported that fatigued and tired with Flu Vaccine (historical vaccine). Sore arm like she got kicked in the arm by a horse. Her arm felt like this today (31Dec2020). Therapeutic measures in response to chest pain is received, treatment included heartburn and gas medications. Gas medication is Equate brand Simethicone Extra Strength Gas Relief (NDC: 49035-487-02, Lot:H22016, Exp: Sep2022) at 125mg liquid-gel. Heartburn medication is Equate brand Cimetidine 200mg tablet (NDC: 49035-820-72, Lot: Doesn't know if lot number is OJE2445C or 0JE2445C, Exp: Jun 2022). Stated writing is so tiny. Gas and heartburn medication has not helped with chest pain. The outcome of the event chest pain was not recovered, of the other events were unknown.
38 2021-01-05 injection site pain, injection site bleeding Symptoms began around 6pm and gradually worsened? sneezing, runny nose, cough, sinus congestion, fev... Read more
Symptoms began around 6pm and gradually worsened? sneezing, runny nose, cough, sinus congestion, fever/chills, body aches (arthralgias, myalgia), headache, site injection pain (which was immediate upon injection, I bled- not a good administration), polyuria/difficulty sleeping overnight, I felt like I was very sick with the flu.
38 2021-01-05 injection site redness, injection site swelling Woke up with sore left arm and some redness and swelling at injection site on 1.5.21. Chills and ge... Read more
Woke up with sore left arm and some redness and swelling at injection site on 1.5.21. Chills and generalized body aches began about 1230, temperature taken at that time was 99.0. Continued with work and by 1530 began to have increased myalgias and pain in knees, took temperature 100.0 and took 400mg Ibuprofen. Fever broke, began to have diaphoresis and felt body aches were gone with exception to left arm. Woke up 1.6.21 and with pain in left axilla and noted to have tender and swollen lymphnodes. Took another 400mg Ibuprofen about 0830. Muscle pains remain to arm, axilla and neck.
38 2021-01-05 itchy skin itching; This is a spontaneous report from a contactable nurse reported for herself. A 38-year-old f... Read more
itching; This is a spontaneous report from a contactable nurse reported for herself. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date unknown), via an unspecified route of administration on the right upper arm deltoid on 28Dec2020 at single dose for covid-19 immunisation. The patient medical history included Gallbladder removal from 2019 to 2019, asthma but grew out of it which the last time she had an attack was when she was 12 years old, C-sections for her kids. The patient concomitant medications reported as none. The patient was got the COVID vaccine, the first shot and she experienced itching that's why she took the Benadryl 50 mg. She didn't know if that was normal for people who had the covid vaccine to experience this. The vaccine was received on Monday, 28Dec2020 and the itching started Tuesday on 29Dec2020. She was ok on Wednesday 30Dec2020 but today she is itching again. She took Benadryl 50mg the day the itching started, just once and the next day she was fine. It is explained that the itching was not severe and she was not scratching her skin, she just feel itchy like something was crawling on her skin. She has no known allergies but does remember when C sections had for her kids, she had severe itching with the epidural, she experienced this with but it happens every time she gets an epidural. She has had no adverse events or allergic reactions to any other vaccines. The vaccine was administered on the right upper arm deltoid. The outcome of the event was not recovered.
38 2021-01-06 rash I became flush in my face and broke out with a rash on my arms and back. I just took Benadryl at hom... Read more
I became flush in my face and broke out with a rash on my arms and back. I just took Benadryl at home.
38 2021-01-06 itchy skin, injection site pain Itchiness on right side of body, Mild headache, running nose and moderate soreness around injection ... Read more
Itchiness on right side of body, Mild headache, running nose and moderate soreness around injection site.
38 2021-01-06 injection site pain Low grade fever, site soreness, fatigue, headache
38 2021-01-06 rash My face became flush and broke out rash on back and shoulder.
38 2021-01-06 skin spots, itchy skin Pt in clinic for 1st COVID vaccination. Nurse reviewed screening checklist, nurse queried pt related... Read more
Pt in clinic for 1st COVID vaccination. Nurse reviewed screening checklist, nurse queried pt related to severe reactions to any injected medications or immunization previously. Pt denied any severe reaction history to injected medications or immunizations. Pt was administered COVID Pfizer injection approx. 0900. At approx. 0910 pt returned to nurses room reporting having stomach cramping. Pt reports attempted to use bathroom without success. Nurse notified Lead Nurse, NP. Emergency kit obtained, vital signs collected while Lead Nurse consulted Nursing Director, DNP, per consultation Lead Nurse contacted 9-1-1. Pt SpO2 stable in high 90's, pt did not present with difficulty breathing at that time, pt reported ongoing stomach pain and itching on abdomen. Pinprick petechiae observed on thoracic area, pt actively scratching. Per Lead Nurse, NP consultation with Nursing Director, DNP IM Bendaryl advised. Pt notified nurses of PMH allergy to Benadryl. Pt indicated when school-aged had anaphylactic reaction to penicillin and given IV Benadryl at that time, resulting in hives. Pt further reported allergic reaction to unknown facewash when 18 years old, when presented at MD office at that time was given IV Benadryl, subsequently sent to hospital at that time for severe reaction. Per consultation with Nursing Director epinephrine indicated. Nurse, RN administered epi-pen autoinjector 3mg at 09:22 (lot #G200810X, expiration 12/2021). Post epinephrine administration pt experienced nausea with vomiting and expressed feeling anxious. Pt affect became more somnolent with stomach upset. EMS arrived to clinic and pt consented to transport. Transfer of care to EMS approx. 09:45. RN
38 2021-01-07 hives Clinic Manager reports that EE received first dose Covid-19. EE reports that after 15 minutes EE bec... Read more
Clinic Manager reports that EE received first dose Covid-19. EE reports that after 15 minutes EE became unwell and was sweating. EE reports that EE was seen in clinic by providers and had elevated blood pressure and hives
38 2021-01-07 injection site pain Fever, injection site tenderness, body aches, joint pain, severe headaches, fatigue
38 2021-01-07 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA. Burning in the arm during vaccination and after
38 2021-01-07 injection site pain Shaking chills, lasting 2-3 hours, onset about 10 hours after administration with associated fever A... Read more
Shaking chills, lasting 2-3 hours, onset about 10 hours after administration with associated fever Also had localized soreness at site of admin that began 4-6 hours after admin, and is still a little present 2 days post admin, but improving
38 2021-01-07 injection site redness, injection site swelling Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. I... Read more
Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. Injection site was swollen right after it was administered and red and warm to the touch for 5 days.
38 2021-01-07 injection site pain nausea, fatigue, injection site painful
38 2021-01-07 hives, itchy skin, redness patient developed hives on heck, erythema/redness all up arms and neck, itchy on arms and feels warm... Read more
patient developed hives on heck, erythema/redness all up arms and neck, itchy on arms and feels warm behind ears. patient reports she has had many allergies (non-drug) in the past and has received allergy shots. patient received Famotidine and Prednisone in ED and discharged home
38 2021-01-08 injection site pain Muscle aches, nausea, fatigue, injecton site pain
38 2021-01-08 itchy skin, redness, skin swelling Right middle toe started with severe itching. It turned red and slightly swollen. 2 days later, 2 sm... Read more
Right middle toe started with severe itching. It turned red and slightly swollen. 2 days later, 2 small pustules appeared on top of the toe. Only 1 toe has ever been affected.
38 2021-01-09 injection site reaction Chills, joint pain, fatigue, local reaction. Benadryl, ibuprofen q6h
38 2021-01-09 skin warm Patient c/o tongue swelling, throat tingle and chest pain. Warm tingling around mouth. VS.Benadryl ... Read more
Patient c/o tongue swelling, throat tingle and chest pain. Warm tingling around mouth. VS.Benadryl 25 min 7:43, Epi Pen Eipi-Pen at 07:45, Rapid response called, Epi Pen working. Transferred to ED.
38 2021-01-09 injection site pain Same day of injection: general malaise and tiredness within 2 hours of shot Day 2: malaise and tired... Read more
Same day of injection: general malaise and tiredness within 2 hours of shot Day 2: malaise and tiredness lessened, but incredible soreness to injection site (left deltoid) Day 3: moderate diarrhea
38 2021-01-09 injection site swelling, injection site warmth, redness Severe arm pain, swelling at injection site, redness, warm to touch. Feverish, chills, headache, di... Read more
Severe arm pain, swelling at injection site, redness, warm to touch. Feverish, chills, headache, diarrhea, severe body aches, joint pain.
38 2021-01-10 hives 38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immed... Read more
38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immediately after receiving the vaccine, patient developed lightheadedness, flushing, hives, wheezing and throat swelling. Patient was treated in an emergency department with epinephrine, gradually improved and was able to be sent home with an EpiPen, prednisone, hydroxyzine, and famotidine. The next day, patient again developed shortness of breath and her husband administered the EpiPen. EMS arrived and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on epinephrine drip. Stridor continued and was unresponsive to nebulized albuterol. Patient was then intubated and placed on mechanical ventilation. Other treatments included solumedrol, pepcid, magnesium sulfate, nebulized epinephrine, and IV fluids. admitted to the intensive care unit, weaned off epinephrine drip, and extubated the next day. Patient was monitored on hospital floor for one additional day and was then discharged with no residual symptoms.
38 2021-01-10 redness 7 days after my first Pfizer COVID vaccine, I developed mastitis. It began in the morning with mild ... Read more
7 days after my first Pfizer COVID vaccine, I developed mastitis. It began in the morning with mild generalized muscle and joint pain and progressed to moderate to severe joint pain, a fever of 102 degrees, and localized redness and swelling of the left breast over the course of 12 hours. Treatment with Cephalexin 500 mg PO QID for 14 days was initiated within 12 hours of onset. The systemic symptoms resolved within 24 hours of treatment onset and the breast redness and swelling resolved within 72 hours. While I am aware that an infectious mastitis is likely unrelated to the vaccine, I opted to report this incident because I have breastfed 3 children and have never had mastitis prior to this event and because of the limited information available on this vaccine in lactating women.
38 2021-01-10 injection site pain Body aches and headache beginning at 4 am on 1/9/2021. Fever at 9:30 am 1/9/2021 to 100.5. Swollen ... Read more
Body aches and headache beginning at 4 am on 1/9/2021. Fever at 9:30 am 1/9/2021 to 100.5. Swollen left axillary lymph node noted. Sunday 1/10/2021 symptoms resolved except for lymph node enlargement and soreness at injection site. Taking tylenol and motrin with relief.
38 2021-01-10 itchy skin Developed throat itching and fullness approximately 45 minutes post vaccination. Between 1-1.5 hours... Read more
Developed throat itching and fullness approximately 45 minutes post vaccination. Between 1-1.5 hours, itching of head, neck, and face. No shortness of breath or rash identified. Diphenhydramine 50 mg PO and methylprednisolone 12 mg PO taken upon arriving home.
38 2021-01-10 injection site pain Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for severa... Read more
Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for several hours, racing heart rate, sudden hot feeling, extreme headache, extreme fatigue, brain fog, irritability, pain at injection site.
38 2021-01-10 rash, rash with redness Patient presented with a red widespread rash on her neck and chest at 1655
38 2021-01-10 injection site pain Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the ev... Read more
Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the evening - Aleve worked temporarily and then the side effects got worse, took another Aleve and eventually was able to sleep it off Arm aches at site of injection - still tender t otouch
38 2021-01-10 redness The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after ... Read more
The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after shot I started to feel extreme fatigue, muscle aches, slightly sore throat, mild congestion. I had a temperature of 99.1. I went to an urgent care and my BP was elevated (very unusual for me) 140/100 and HR 110 and temp still 99.1. They did a rapid swab on me that was negative. I continued to feel awful the rest of the day. On Sunday the next morning I awoke because I had a very swollen and sore lymph node in my left armpit. I took tylenol and did warm compresses. I had continued fatigue on Sunday and slept the whole day. I also continued with a high heart rate 110-130 with activity. My Bp was 117/70I had a pulse oximeter at home. My temp stayed 99. Monday morning I woke up feeling better. My HR was in the 80 and temp 98.3 and fatigue is gone. I still have mild soreness in my left arm but the redness is fine and warmth is gone. My left armpit is still sore
38 2021-01-10 injection site redness fatigue achy on 1/8 and nausea x 1 hour and redness at the injection site on 1/10. Pedialyte with im... Read more
fatigue achy on 1/8 and nausea x 1 hour and redness at the injection site on 1/10. Pedialyte with improvement of symptoms.
38 2021-01-10 redness within minutes entire body numbness and "hot", followed by full body erythema. Was transported to th... Read more
within minutes entire body numbness and "hot", followed by full body erythema. Was transported to the ED for treatment.
38 2021-01-11 itchy skin Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness ... Read more
Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness and pain, tongue swelling, lip swelling, difficulty breathing, chest tightness, fast heartbeat, increased blood pressure. Given benadryl, epi, solu-medrol and pepcid. Kept for observation. After release, continuing to have intermittent hot flashes, itching all over face and body, occasional jaw tightness, sore throat and tongue, increase in pulse, O2 sats in low 90s,
38 2021-01-11 cellulitis Facial cellulitis, eye swelling, headache, nausea
38 2021-01-11 rash, rash with redness, rash papular Raised red rash that lasted 8 hours on hips, stomach. chest and thighs. Not bothersome .No treatment... Read more
Raised red rash that lasted 8 hours on hips, stomach. chest and thighs. Not bothersome .No treatment needed.
38 2021-01-11 rash, bruising Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked lik... Read more
Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked like an egg under my arm, very visible very very sore/couldn't move my arm without it hurting; rash; hot to the touch; bruising; dizziness; nauseous; headache; body ache; muscle ache; very tired; joint pain; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET1685, expiration date not reported), via an unspecified route of administration on the left arm, on 30Dec2020 at 11:45 at a single dose for Covid-19 immunization. Medical history included latex and shellfish allergy. Patient was diagnosed with Covid-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ergocalciferol (VITAMIN D), calcium, topiramate, and cyanocobalamin (vitamin B12). The patient previously took erythromycin, terbutaline, iodine and experienced drug allergies. On 30Dec2020 at 11:45, the patient experienced swelling that looked like an egg under her arm, very visible very very sore, rash, hot to the touch, bruising, dizziness, nauseous, headache, body ache, muscle ache, very tired, couldn't move arm without it hurting, joint pain, and loss of appetite. On 04Jan2021, the patient had a nasal swab and was tested for COVID-19, both with unknown result. The patient did not receive treatment for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious.
38 2021-01-11 redness, itchy skin Two days after receiving 2nd dose of COVID19 vaccine, red itchy areas to upper legs and arms. Progre... Read more
Two days after receiving 2nd dose of COVID19 vaccine, red itchy areas to upper legs and arms. Progressed next day. Today 1/12/21 employee showed me additional red areas to arms, face, outer eyes and states red areas to abdomen. Otherwise feels well.
38 2021-01-11 vaccination site pain pain at injection site; body aches; mild headache; This is a spontaneous report from a contactable n... Read more
pain at injection site; body aches; mild headache; This is a spontaneous report from a contactable nurse (patient herself). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142; expiry date: unknown) via an unspecified route of administration, on 04Jan2021, at 0.3 mL, single for COVID-19 immunization. Patient has no relevant medical history. Concomitant medications were not reported. Prior to taking vaccine, she did an antibody test and it was positive for antibodies s in Nov2020, she remembered that she went for a complete physical. All COVID tests were negative but the antibody test was positive. She did a rapid test a week before the vaccine at the end Dec2020. The PCR Test was a couple months before the vaccine in Apr2020 and it was negative. During that time in Apr2020 she had mild symptoms and was not feeling well but then she felt better. The doctor gave her azithromycin and vitamins, a week later she was better. At her job they were doing COVID test every 2 weeks, but she was negative. She had no more symptoms. She has had no issues with vaccines in the past. She would get unspecified flu shots at work for flu vaccination, but would get mild pain at the injection site. Patient received PFIZER-BIONTECH COVID-19 VACCINE on 04Jan2021 and had been experiencing pain at injection site, mild body aches, and mild headaches. Her 1st dose was on 04Jan2021 at 4 o clock. The pain at injection site began on 05Jan2021. The body aches and headache also started on 05Jan2021, but she noticed relief with Tylenol. She has called her physician since she does not want to go in office. Her symptoms were ordinary and mild but bothersome, she doesn't know with this vaccine and what she would be feeling and decided on staying home. The pain at injection site stopped sometime between yesterday and today. Her 2nd dose is scheduled on 25Jan2021. Outcome of the event pain at injection site was recovered on an unspecified date in Jan2021, while for the remaining events was recovering.
38 2021-01-11 vaccination site warmth, rash papular, vaccination site rash small bulging rash on injection site that feels warm and is growing larger; small bulging rash on in... Read more
small bulging rash on injection site that feels warm and is growing larger; small bulging rash on injection site that feels warm and is growing larger; small bulging rash on injection site that feels warm and is growing larger; BNT162B2 first dose was administered on 23Dec2020, second dose was administered on 04Jan2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 04Jan2021 09:00 at single dose for Covid-19 immunization. The first dose was administered on 23Dec2020 15:00 via an unspecified route of administration at single dose. The patient's medical history was not reported. No known allergies. Concomitant medication included fluoxetine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced a small bulging rash on injection site that feels warm and is growing larger on 04Jan2021 at 11:45 PM. It was unknown if a treatment has been received for the event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. Information about batch/lot number has been requested.
38 2021-01-12 injection site pain 13 hours after vaccination developed severe arm tenderness at injection site, aches and chills. The... Read more
13 hours after vaccination developed severe arm tenderness at injection site, aches and chills. These lasted about 12 hours. Aches and exhaustion continued another 6 hours.
38 2021-01-12 injection site pain Began with shooting sharp pains in left foot gradually going up my left leg. At that point I took al... Read more
Began with shooting sharp pains in left foot gradually going up my left leg. At that point I took aleve and a trazadone in hopes of getting some rest. I fell asleep. I woke up around 0200 on 1/13/21 with extreme muscle and joint aches, a sensation of pins, needles, and tingling all over my body I felt very jittery and was actually shaking slightly throughout the ordeal. I felt like my nervous system was overloaded and my perception of pain was extremely heightened. At one point during this 4 hour period I had a visual hallucination. By 0600 I was feeling better- more relaxed. Muscle aches and sore joints are still present today. Also have a slight increase in temp 99.6 and injection site pain.
38 2021-01-12 injection site pain Body Aches, Fatigue, Injection site pain
38 2021-01-12 rash with redness, rash papular, hives, itchy rash, rash Pt developed itchy, painful red, raised rash appears consistent with hives
38 2021-01-13 injection site pain 1/11:motrin 800mg 1 hr prior to injection. minor pain at injection site. no redness or swelling no... Read more
1/11:motrin 800mg 1 hr prior to injection. minor pain at injection site. no redness or swelling noted. 1/12: still minor soreness at injection site but around bed time , I noticed pain in my armpit and swelling( fluid filled area) around possible lymph node. Palpable lymph node along left clavicle with similar fluid filled swelling. Took motrin throughout the day and 50 mg of benadryl at bedtime. 1/13: Left arm pit still swollen. more tender with movement. While at work i put hot compress in my arm pit to help with the pain and shortly after i noticed my left arm had bright red streaks from my arm pit to my wrist. It also was very mottled looking. My arm felt tight/heavy or kind of like a pinched nerve feeling.. I took motrin throughout the day for soreness and took benadryl at bedtime. I place ice pack under my arm during the evening as well. 1/14: Swelling remains in the armpit. Tenderness is getting better. Similar swelling around clavicle . Still taking motrin for inflammation and using ice pack under my arm.
38 2021-01-13 injection site pain, sensitive skin 1/12: 12:01am: Shaking chills, body pain, headache, nausea, faint, skin sensitivity, pain at injecti... Read more
1/12: 12:01am: Shaking chills, body pain, headache, nausea, faint, skin sensitivity, pain at injection site left arm. Temp 98.6 1/12: 0600am: Shaking chills, cold sweat, faint, nausea, headache, body pain, fatigue, skin sensitivity, pain injection site. 1/12: 0630am: Same as above, Temp 100.9, took Ibuprofen 3 tabs. 1/12: 0730am: Less of all symptoms, ate food. 1/12: 12:30pm: Headache, body aches and pains, weakness, fatigue, nausea, skin sensitivity, pain at injection site. 1/12: 1:12pm: Temp 99.5. took ibuprofen 3 tabs. 1/12: 2:15pm-3:40pm: Breakthrough body aches, pains, headache, skin sensitivity, pain at injection site. 1/12: 7:40pm: Body aches, tired. Temp 98.3. took Ibuprofen 3 tabs. 1/13: 0800: Slept well, no further pain medication, no further side effects except mild soreness at injection site. 1/24: 0800: no soreness to injection site.
38 2021-01-13 injection site pain 12 hours after vaccine Fever, chills, muscle pain, joint pain lasting 14 hours. followed by tightnes... Read more
12 hours after vaccine Fever, chills, muscle pain, joint pain lasting 14 hours. followed by tightness in chest lasting 14 hours. Dry cough lasting 5 hours. Swollen lymph nodes on injection side arm pit lasted 48 hours. Tender abdomen, nausea started at 24 hour mark and lasted about 18 hours. Fatigue lasted 72 hours post vaccine.
38 2021-01-13 vaccination site pain Burning after injection; This is a spontaneous report from a contactable pharmacist. A 38-year-old ... Read more
Burning after injection; This is a spontaneous report from a contactable pharmacist. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, intramuscular in the left arm, from 08Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced burning after injection on 08Jan2021. The outcome of event was recovering. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
38 2021-01-13 redness Facial numbness, face turned red elevated BP
38 2021-01-13 injection site redness, injection site swelling, injection site mass, injection site inflammation Fever, chills, body aches, headache. Injection site is red and inflamed. It is also swollen and a... Read more
Fever, chills, body aches, headache. Injection site is red and inflamed. It is also swollen and a hard lump.
38 2021-01-13 injection site swelling, injection site hives, injection site warmth, injection site pain, injection site pruritus Had COVID vaccine and had reaction. Large welts at site of injection, warm to touch, very swollen an... Read more
Had COVID vaccine and had reaction. Large welts at site of injection, warm to touch, very swollen and tender. Itchy around that area.
38 2021-01-13 rash Patient presented for her second Pfizer vaccine January 11, 2021. She waited her 15 minutes and sta... Read more
Patient presented for her second Pfizer vaccine January 11, 2021. She waited her 15 minutes and started to pull away when she noticed that she was beginning to get warm. She looked in her car mirror and noticed a rash on her neck and chest. She then pulled back around to let us know of her reaction. Vital signs checked. BP was 122/68. HR was 97. Sp02 was 99% on RA. She denied any SOB. At 1657 she was given Benadryl 25 mg po that she swallowed without any difficulties. She reported that she began to feel better. Rash started to look better. Patient will wait another 15 minutes to make sure that her symptoms resolve. Patient is A0x4. She is talking without difficulty.
38 2021-01-13 rash Rash; This is a spontaneous report from a contactable physician (patient herself). A 38-year-old fem... Read more
Rash; This is a spontaneous report from a contactable physician (patient herself). A 38-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on left arm on 05Jan2021 08:15 at single dose for covid-19 immunization, administered at hospital. Medical history included asthma. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced rash within 12 hours on 05Jan2021. The reported event was non-serious. The patient underwent lab tests and procedures which included nasal swab-PCR on 07Jan2021 with pending result. Therapeutic measures were taken as a result of rash with steroid cream and antihistamine. The outcome of the event was not recovered. No follow-up attempts are possible; Information on the lot/batch number cannot be obtained.
38 2021-01-13 injection site pain Sever sore arm at injection site and to move arm, body aches, and fatigue.
38 2021-01-13 injection site pain Soreness at the injection site, arm pain
38 2021-01-13 injection site pain Soreness at the injection site, arm pain, headache and full body chills
38 2021-01-13 itchy skin, bruising Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At ... Read more
Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At approximately 7:00 pm EE reports she went to store and when she went to get out of her car she felt really dizzy. EE reports she hadn?t eaten much that day so tried to eat some chocolate covered pretzels and coke. EE denied syncope. EE reports she started feeling ?chest tightness? and starting panicking. EE denies airway issues and SOB. EE said she got nervous and went to Hospital across the street for assessment. EE reports at triage her SPO2 was 100% but slightly tachycardiac. EE reports after her triage assessment she called her daughter to come pick her up and did not seek further medical care. EE reports when she got home she started with generalized itchiness, denies rash. EE reports she took 50 mg Benadryl, 25 mg Atarax, and 40 mg Pepcid at 8:45 PM. EE reports not change in itchiness and took 2nd dose of 50 mg Benadryl around 01:30 (1/14). EE reports she woke up around 06:45 (1/14) with bilateral arm bruising from scratching overnight per EE and feeling chilled. Last day of work and shift - ? scheduled to work tonight (1/14) Home remedies? ? see symptoms for home remedies Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE encouraged to take Claritin and Benadryl as outline by the Medical Directive at TCH. EE educated to only take Benadryl if she will be at home today and that is she unable to take Benadryl when at work, EE verbalized back understanding. EE educated if she is still feeling unwell for her shift tonight, to notify her manager and to manage per hospital Illness in the Workplace Policy. EE denied further questions at this time.
38 2021-01-13 itchy skin, bruising Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At ... Read more
Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At approximately 7:00 pm EE reports she went to store and when she went to get out of her car she felt really dizzy. EE reports she hadn?t eaten much that day so tried to eat some chocolate covered pretzels and coke. EE denied syncope. EE reports she started feeling ?chest tightness? and starting panicking. EE denies airway issues and SOB. EE said she got nervous and went to hospital across the street for assessment. EE reports at triage her SPO2 was 100% but slightly tachycardiac. EE reports after her triage assessment she called her daughter to come pick her up and did not seek further medical care. EE reports when she got home she started with generalized itchiness, denies rash. EE reports she took 50 mg Benadryl, 25 mg Atarax, and 40 mg Pepcid at 8:45 PM. EE reports not change in itchiness and took 2nd dose of 50 mg Benadryl around 01:30 (1/14). EE reports she woke up around 06:45 (1/14) with bilateral arm bruising from scratching overnight per EE and feeling chilled. Last day of work and shift - ? scheduled to work tonight (1/14) Home remedies? ? see symptoms for home remedies Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE encouraged to take Claritin and Benadryl as outline by the Medical Directive at hospital. EE educated to only take Benadryl if she will be at home today and that is she unable to take Benadryl when at work, EE verbalized back understanding. EE educated if she is still feeling unwell for her shift tonight, to notify her manager and to manage per hospital Illness in the Workplace Policy. EE denied further questions at this time.
38 2021-01-13 vaccination site redness, vaccination site warmth, vaccination site swelling sever body aches; head ache; nausea; Arm where vaccine was giving was swollen and red; Arm where vac... Read more
sever body aches; head ache; nausea; Arm where vaccine was giving was swollen and red; Arm where vaccine was giving was swollen and red; Arm where vaccine was giving was swollen and red and warm to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient (no pregnancy) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at site of right arm at 15:00 on 28Dec2020 at single dose for COVID-19 immunization. Medical history included eczema psoriasis, allergies: Augmentin, and birth control. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC) for birth control within 2 weeks of vaccination and levocetirizine dihydrochloride (XYZAL). At 06:00 on 29Dec2020, the patient experienced sever body aches, headache and nausea. Arm where vaccine was giving was swollen and red and warm to the touch, body aches lasted for 24 hours, arm issue didn't not go away for 5 days. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of event arm where vaccine was giving was swollen and red and warm to the touch was recovered in Jan2021; of rest events was recovered at 06:00 on 30Dec2020.
38 2021-01-14 injection site swelling, injection site redness, injection site reaction 24 hours post vaccine began to experience injection site reaction. Localized tissue reaction includi... Read more
24 hours post vaccine began to experience injection site reaction. Localized tissue reaction including swelling at site, 8cm redness (continues to grow 48 hours post vaccine administration)
38 2021-01-14 injection site pain Developed a fever of 101 12 hours post vaccine administration along with other symptoms. Took Tyleno... Read more
Developed a fever of 101 12 hours post vaccine administration along with other symptoms. Took Tylenol at 03:20 am with improvement in symptoms. Fever up 100.7 persisted after Tylenol wore off along with myalgias. No other symptoms beyond what was listed. Employee Health was contacted. chills, fatigue, fever, headache, injection site pain and new or worsened muscle pain
38 2021-01-14 hives Fever, chills, hives, body aches
38 2021-01-14 rash My entire arm is painful and there is now a knot under my left arm pit that is tender and there is r... Read more
My entire arm is painful and there is now a knot under my left arm pit that is tender and there is rash also under the same arm pit.
38 2021-01-14 injection site pain Sore arm and pain at injection site
38 2021-01-14 injection site swelling, injection site redness chills, muscle pain, Nausea swelling and redness on injection site
38 2021-01-14 vaccination site pain sore throat; Fatigue; fever; injection site soreness; This is a spontaneous report from a contactabl... Read more
sore throat; Fatigue; fever; injection site soreness; This is a spontaneous report from a contactable other HCP (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via uknown route of administration, on 06Jan2021 at 11:15 AM (at the age of 38 years old) as a single dose in the right arm for COVID-19 immunization at hospital facility. Relevant medical history included anxiety and depression. The patient has known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 evening, the patient experienced injection site soreness at 6:30 PM, fatigue and fever at 7:30 PM. Fatigue and fever were gone by morning. Injection site soreness faded every day. On 08Jan2021, the patient experienced sore throat. No treatment was received for the events injection site soreness, fatigue, fever and sore throat. The outcome of the events injection site soreness, fatigue, fever and sore throat was recovering. The patient was not pregnant at time of vaccination. Since the vaccination, the patient had been tested for COVID-19 via COVID test Nasal Swab on 08Jan2021 with pending result. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
38 2021-01-15 injection site pain Approximately 28 hours after injection I started experiencing intermittent numbness and tingling in ... Read more
Approximately 28 hours after injection I started experiencing intermittent numbness and tingling in the right hand. At 33 hours post injection developed a deep dull aching pain throughout entire right arm. This worsened, and after 2 more hours intermittent sharp shooting pain down the arm. Pain rated 6 out of 10 intermittently with a constant 3 out of 10 full ache. Difficulty falling asleep due to discomfort and at one point the pain woke me up from sleep. It was resolving by early the next morning, and disappeared by hour 48 post injection. These pains were not inclusive of the soreness and tenderness of the injection site or the muscle pain when lifting the arm. Those symptoms are still present to a minimal extent 54 hours after injection, at the time I am writing this report.
38 2021-01-15 shingles Developed shingles starting 48 hours after vaccination
38 2021-01-15 injection site redness, injection site pain, vaccination site hardening Large (approx 3 inches), hard, red area around vaccination site. Area very sore and tender to touch.
38 2021-01-15 injection site redness developed headache, myalgia, arthralgia, fatigue, collarbone & back motrin helped 1/13 begain again ... Read more
developed headache, myalgia, arthralgia, fatigue, collarbone & back motrin helped 1/13 begain again 1/14 redness tangerine size at injection site- motrin 1/15/21 recovered no redness at injection site- aches gone
38 2021-01-15 itchy skin, rash, redness sudden onset redness with rash to face and neck, generalized itching to upper body, skin tingling
38 2021-01-17 rash Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presented for her second Pfizer vaccine January 11, 20... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presented for her second Pfizer vaccine January 11, 2021. She waited 15 minutes and started to pull away when she noticed that she was beginning to get warm. She looked in her car mirror and noticed a rash on her neck and chest. She then notified staff of reaction. Vital signs checked. BP was 122/68. HR was 97. Sp02 was 99% on RA. She denied any SOB. She was given diphenhydramine po that she swallowed without any difficulties. She reported that she began to feel better. Rash started to look better. Patient waited another 15 minutes. Patient was alert and oriented x4 and was talking without difficulty.
38 2021-01-18 skin spots 1638: Presented with dizziness, lightheaded, feeling flush, feels impending sense of doom, BP 138/82... Read more
1638: Presented with dizziness, lightheaded, feeling flush, feels impending sense of doom, BP 138/82 (high for patient), Heart rate 75, Patient alert and oriented X3, Respiration easy and unlabored, Denies shortness of breath 1645: BP: 138/82 HR 82 99% Biox 1647: Went to get husband in the parking lot 1648: EMS called 1650: Husband with patient, patient still nausea 1653: Petechial rash observed to upper chest 1654: resting in supine position in recliner 1655: 118/70, HR 99, 99% Biox, 20 respiration 1700: EMS here 1703: no flu shot this year 1706: Left with EMS ? Patient reques
38 2021-01-18 injection site pain Arm pain at site of shot, nausea, diarrhea
38 2021-01-19 itchy skin 11 minutes after receiving shot, scalp on head started itching, tongue started swelling, area around... Read more
11 minutes after receiving shot, scalp on head started itching, tongue started swelling, area around tonsils felt like it was swelling. Pt received epi, and lips/tongue/throat continued to swell and itching spread to different parts of face.
38 2021-01-19 vaccination site pain, hardening Nausea.Headache, fatigue, muscle aches,body soreness; and soreness at vaccination site - about 6 hr... Read more
Nausea.Headache, fatigue, muscle aches,body soreness; and soreness at vaccination site - about 6 hrs later; Two days after vaccine tender to touch left elbow started hurting - later that day I could feel a hard rod-like structure in the elbow on that side > Two days after vaccine - whole arm was hurting. Developed Lymphadenopathy. Fourth day after vaccine: Auxiliary tail of Left breast was hard as well. Called my PCP - warm compresses and Ibuprofen. My arm - I still feel a hard vein in my left arm. The other symptoms went away after 6 or 7 days. (Although nausea stopped after two days.)
38 2021-01-19 skin spots, rash papular, itchy skin Papular rash with petechiae and itching 10 days after vaccine
38 2021-01-19 itchy skin Patient c/o "flushing" at 1725. Patient offered water. 1730 patient complained "I am not going to l... Read more
Patient c/o "flushing" at 1725. Patient offered water. 1730 patient complained "I am not going to lie, I am not feeling well." Reported that "the water didn't want to go down" and c/o "throat shutting down." Reports feeling nauseous and started to itch both lower arms. 1737 0.5ml epinephrine administered IM to right deltoid, 911 called. BP 132/82, pulse 92, O2 96% on RA. EMS arrived at 1745 and transported to ER at 1758. Called client morning of 1/15 and reported Benadryl given IV while transported to ER, discharged to home at 2130 on 1/14.
38 2021-01-19 itchy skin Systemic: Anxiety / itchiness
38 2021-01-20 skin discolouration Burning pain in feet, discoloration of multiple toes
38 2021-01-20 rash, itchy rash Itchy Rash on Stomach, and legs
38 2021-01-20 rash LT arm was so sore I could not move it. 01/19/2021 Rash all over my up body (shoulders neck head), a... Read more
LT arm was so sore I could not move it. 01/19/2021 Rash all over my up body (shoulders neck head), arm still sore. Took over the counter meds. Lt arm still hurts 01/20/2021 No more rash, but shoulders and upper back are super tight. I am also super tired today. 01/21/2021
38 2021-01-20 injection site redness, injection site pruritus, injection site hardening, injection site pain, injection site swelling Swelling and redness at injection site, hard bump, tender, itchy Tues. 1/19/2021 - 1530 - size of a... Read more
Swelling and redness at injection site, hard bump, tender, itchy Tues. 1/19/2021 - 1530 - size of a quarter Thurs. 1/21/2021 - 1000 - Size of a lemon Warm and cold compresses applied, IB Porphin
38 2021-01-20 rash, redness, injection site pruritus, skin discolouration, itchy skin The day after I had the shot, i started to itch on my left arm , around the area I had the shot,,and... Read more
The day after I had the shot, i started to itch on my left arm , around the area I had the shot,,and then it developed into a rash like situation on both arms...the itching was so intense and then i noticed tiny bumps and black and blue spots along my right and left arm. It then spread to my thighs and upper chest area. I also had tightness in my throat and i took some Benadryll over the weekend hoping it would go away but it didn't. It got worse. On Monday, it was swollen on both arms and looked more like hives, red itchy with tiny bumps. On Tuesday, I went to my PCP who indicated it may have been an allergic reaction from the vaccine. She gave me Medrol and that is what I have been taking. Today the itching is a little less intense ..
38 2021-01-20 sensitive skin Tremendous body aches. Skin sensitivity. Sound created body pain waves. Fatigue. Mild nausea. 9 pm T... Read more
Tremendous body aches. Skin sensitivity. Sound created body pain waves. Fatigue. Mild nausea. 9 pm Tuesday through 5 pm Wednesday.
38 2021-01-20 hives, rash hives; rash on her neck, largely on her chest across both breasts and some going down her belly, nea... Read more
hives; rash on her neck, largely on her chest across both breasts and some going down her belly, near her belly button and upper back; This is a spontaneous report from a contactable pharmacist reporting for herself. A 38-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer -BioNTech, Lot# EL0140), intramuscular in left arm, on 08Jan2021 at 14:00, at single dose, for COVID-19 immunisation. Medical history included ongoing hypothyroidism (diagnosed about 25 years before) and COVID-19 from Oct2020 to an unknown date. Concomitant medications were not reported. The patient experienced hives on 10Jan2021 with outcome of not recovered; rash on her neck, largely on her chest across both breasts and some going down her belly, near her belly button and upper back on 10Jan2021 with outcome of not recovered. The events did nor require emergency room visit or physician office visit. The reporter considered the events as non serious, stated they were not interfering, not causing any issues. The reporter also stated that she was not convinced that they were due to the vaccine, since she thinks it is autoimmune (her body's immune response to the vaccine). She gets the same type of rash when she gets sick.
38 2021-01-20 vaccination site pain moderate diarrhea; incredible soreness to injection site (left deltoid); general malaise tiredness w... Read more
moderate diarrhea; incredible soreness to injection site (left deltoid); general malaise tiredness within 2 hours of administration; general malaise tiredness within 2 hours of administration; This is a spontaneous report from a non-contactable nurse reporting for herself. A 38-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142, expiry date not reported) on 06Jan2021 intramuscularly in the left arm for COVID-19 immunization. There was no relevant medical history and no concomitant medications. The patient had not had COVID prior to the vaccination and she was not tested post the vaccination. On 06Jan2021, the patient experienced general malaise tiredness within 2 hours of administration. On 07Jan2021, she experienced severe soreness (stated as "incredible soreness") to injection site (left deltoid). On 08Jan2021, she experienced moderate diarrhea (per CDC systemic reaction classification). The events were non-serious. No treatment received for the events. The events were resolved on an unspecified date in Jan2021. No follow-up attempts are possible. No further information is expected.
38 2021-01-22 rash 5 days after shot began post nasal drip and phlegm in throat. 8 days after shot began rash under arm... Read more
5 days after shot began post nasal drip and phlegm in throat. 8 days after shot began rash under armpits 10 days after shot began sore throat and dry cough 10 days after shot, rash has not improved with hydrocortisone or Allegra and appears to be spreading.
38 2021-01-22 injection site discomfort Leftside sudden onset jaw pain. Jaw pain 7 out of 10. Left arm discomfort to injection site 2 of 10... Read more
Leftside sudden onset jaw pain. Jaw pain 7 out of 10. Left arm discomfort to injection site 2 of 10. Left jaw pain is constant ,achy, and at times throbbing. Unable to close mouth all the way on left side. Unable to chew food due to pain. Received vaccination at 3:10pm and the sudden onset pain started at 8pm the same day. Meds taken: Tylenol, ibuprofen, and benadryl. All meds have been un effective to help control pain. Ice and heat have been un effective for jaw pain. Ice has been effective for injection site pain.
38 2021-01-22 injection site redness, injection site swelling, injection site rash Patient was asked to wait 30 minutes after COVID vaccine administration. (pt has had rash, fever, sw... Read more
Patient was asked to wait 30 minutes after COVID vaccine administration. (pt has had rash, fever, swelling at injection site after flu shot before - after several hours) patient had redness and swelling around the site of the injection in less than 30 minutes and some redness on her chest so she was given 50 mg of Benadryl around 1:45 and the bandage was removed as ice packs were also applied. at 2:04 PM it looked much better and the rash resolved at 2:15, then nausea began. it was better after eating a snack. patient was instructed to check in with PCP after 24 hours if symptoms persisted and to get an EpiPen to have on file in case of emergency after 2nd shot.
38 2021-01-22 injection site pain, injection site swelling, injection site rash, injection site warmth Swollen arm very very painful to move hot to the touch, rash. Fever, nauseous, headache, body ache... Read more
Swollen arm very very painful to move hot to the touch, rash. Fever, nauseous, headache, body ache, dizzy, light headed, fuzzy and faint, loss of appetite very tired. Symptoms started within a few minutes and got worse over time. The Er put me on steroids for 10 day's, antihistamines, and pepsid for 30 days.
38 2021-01-23 redness, vaccination site warmth Localized erythema, warmth, edema at vaccination site (left deltoid), 4 cm by 4 cm
38 2021-01-23 pain of skin, skin swelling On the date listed i noticed significant swelling under my armpit that was very tender, its no longe... Read more
On the date listed i noticed significant swelling under my armpit that was very tender, its no longer tender but its still there. Also the night of the shot I had to sleep semi sitting because my asthma actually bothered me alot, I havnt had this happen to me in quite sometime.
38 2021-01-23 injection site redness, injection site pruritus, injection site swelling Redness, swelling and itching at the insertion site. Redness about 3 inches in diameter and lasted 3... Read more
Redness, swelling and itching at the insertion site. Redness about 3 inches in diameter and lasted 3 days.
38 2021-01-24 hives After about 10 minutes of injection, developed itchiness and tightness of throat. Developed hives le... Read more
After about 10 minutes of injection, developed itchiness and tightness of throat. Developed hives left side of face, under chin, neck and chest. Was also feeling dizzy during observation. Brought to our UCC, vitals stable (HR 80/BP 129/80/02 sat 99%)treated with solumedrol and Benadryl, discharged on prednisone, instructions for bendaryl and an EpiPen. On 1/14 evening, felt "vasovagal", took her vitals at home, per pt HR 39, BP 100/50 and throat felt "constricting". Went to ED, given epi, steroids, oxygen for comfort. No physical evidence of allergy however; ENT performed largynoscope, no mucosal edema or erythema, no rash. Discharged following day and has improved.
38 2021-01-24 vaccination site pain Pfizer-BioNTech COVID-19 Vaccine EUA On 1/23, I had a low-grade fever (highest measurement was 99.6)... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA On 1/23, I had a low-grade fever (highest measurement was 99.6), and my blood pressure was a bit low (92/58 by a home blood pressure measuring device). I also had some mild breast pain that could be related to my period. On 1/23 and 1/24, I had vaccine site muscle pain, fatigue, and dizziness.
38 2021-01-24 injection site pruritus, injection site redness Report redness and itchy at the injection along with swelling of the left supraclavicular lymph node... Read more
Report redness and itchy at the injection along with swelling of the left supraclavicular lymph nodes. Treatment-none. Outcome- itchiness resolved, redness improved-mild and lymph node swelling is improving. Does not interfere with ADL.
38 2021-01-24 injection site pain, skin laceration The day following the 2nd vaccination dose, I had zero symptoms other than a slightly sore injection... Read more
The day following the 2nd vaccination dose, I had zero symptoms other than a slightly sore injection site. Around hour 30 following the vaccination I began to feel warm, and I got up to brush my teeth and cool off in the bathroom. As I was brushing my teeth, I started experiencing an increasing ringing noise in both my ears that I thought was strange and somewhat alarming, but I didn't feel any signs of dizziness or dysphoria. The next thing I remember is waking up the bathroom floor with my husband standing over me. Apparently I experienced a complete lose of consciousness and feel to the floor, hitting my chin on the bathroom vanity as I feel and splitting my chin open, which I have zero recollection of. My husband states that when he found me, that my eyes were open, but I was staring blankly at him with a glazed over look and my whole body was limp and diaphoretic. I came too in about 30 seconds after he found me, but I was very confused, not making a lot of sense, and felt very disoriented and weak. It took about 20 mins for my fever to break, and to have the strength and power to get up and walk to bed. We changed all my clothes because I had soaked through them, and he got me into bed after cleaning/bandaging up my chin. I then slept solidly until noon the next day, which is very unlike me, but since then I have felt relatively fine with no other experiences of fever/chills/disorientation, just some continued mild fatigue off and on. After discussing with my nursing colleagues, they all had similar experiences around hour 24-30 post 2nd vaccine with fevers, chills, restless sleep, or just general malaise, but no one experienced a complete loose of consciousness, so I reached out to my PCP yesterday, and she confirmed today that I should report this to VAERS. I have never experienced any form of loss of consciousness/fainting/black-out/syncope prior to this, which is another reason I thought it was important for me to report this.
38 2021-01-24 redness, itchy skin The patient had redness. chest flushing, and itching about 15 minutes after she received the vaccine... Read more
The patient had redness. chest flushing, and itching about 15 minutes after she received the vaccine. She was given 50mg of diphenhydramine. The itching subsided within 30 minutes after receiving the diphenhydramine. The patient experienced some nausea as well. After monitoring the patient for about an hour she was sent home from work due to the grogginess from the diphenhydramine.
38 2021-01-25 shingles, blister 01/12/21 body aches x 24hrs 01/19/21 Rt back pain, rt chest/torso pain, weakness, headache. 01/2... Read more
01/12/21 body aches x 24hrs 01/19/21 Rt back pain, rt chest/torso pain, weakness, headache. 01/23/21 blisters developed with burning pain and was diagnosed with Shingles at the urgent care Center and more headache
38 2021-01-25 itchy skin AT 2130 ON 1/20/21 DEVELOPED SHAKES, THAT PROGRESSED TO 'CONVULSING. DEVELOPED FEVER OF 104.3. SEVER... Read more
AT 2130 ON 1/20/21 DEVELOPED SHAKES, THAT PROGRESSED TO 'CONVULSING. DEVELOPED FEVER OF 104.3. SEVERE ARM, NECK, AND CHEST PAIN. SHORTNESS OF BREATH THAT IMPROVED OVER TIME. ON 1/23/21 COMPLAINED OF SEVERE ITCHING OVER ENTIRE BODY
38 2021-01-25 injection site warmth, injection site swelling I had terrible insomnia and the worst headache Wednesday night. When I finally went to sleep I tosse... Read more
I had terrible insomnia and the worst headache Wednesday night. When I finally went to sleep I tossed and turned and was cold and hot. I woke up with barely any strength. I slept from 8am-1:30pm Thursday. I had body aches, an upset stomach, muscle aches, and overall felt yucky. Friday I went to work for a presentation and was feeling awful. I had a fever and took some ibuprofen. My injection site was swollen and warm to the touch. I was dripping sweat last night Friday night. My lymph nodes are still swollen under my arm where I got the vaccine and my neck.
38 2021-01-25 injection site warmth, injection site nodule Round circular spot on injection site, feels like a knot, warm to the touch starting 8 days after re... Read more
Round circular spot on injection site, feels like a knot, warm to the touch starting 8 days after receiving the vaccine
38 2021-01-25 redness, itchy skin this was maybe an allergic reaction; itching; her face was red; her arm, it was really red; her arm,... Read more
this was maybe an allergic reaction; itching; her face was red; her arm, it was really red; her arm, it was really puffy; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at deltoid left on an unspecified date at single dose for COVID-19 immunization. The patient medical history was none. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT), biotin and multivitamin. On an unspecified date, the patient reported that she has a lot of itching going on, people were saying her face was red, she felt itchy, it was as if she could write her name on her arm, it was really red and puffy, her left eye stated to itch, but she did not want to scratch, she thought this was maybe an allergic reaction, her pathologist gave her two ZYRTEC, she was supposed to take one, and took another one as well. Course of event was reported as follows: the patient clarified that itching started during night, her scalp started itching a little, then stomach, then she was like ok. The next, she finished working out, got a shower, she did shower and continued to itch. At work, all of a sudden, her arms started itching, then legs started, then stomach and back started itching, her coworker said it was red, face was red. It was not intolerable, but uncomfortable. The patient outcome of the events was unknown.
38 2021-01-26 injection site pain At the vaccination day only soreness at the injection site. I started feeling bad on 12/27/20 with a... Read more
At the vaccination day only soreness at the injection site. I started feeling bad on 12/27/20 with a sore throat. Monday I had a bit of sinus congestion and Tuesday 12/29/20 no sense of smell or taste. I was tested that day on 12/29/20 and was positive.
38 2021-01-26 injection site swelling, injection site redness, injection site hardening, injection site pain, injection site warmth I have a small hard bump at the injection site. It is swollen, warm, and red. It is slightly painf... Read more
I have a small hard bump at the injection site. It is swollen, warm, and red. It is slightly painful to touch.
38 2021-01-26 rash Pt called office on 1/14/2021 and reported that she had her second Pfizer Covid 19 immunization. s... Read more
Pt called office on 1/14/2021 and reported that she had her second Pfizer Covid 19 immunization. she reported having some periorbital edema, facial rash (located underneath her protective face mask) and tingling around her lips. She had self medicated with some cetirizine . we provided her an injection of solumedrol IM. Symptoms resolved.
38 2021-01-26 injection site pain Soreness at the injection site
38 2021-01-26 injection site mass Soreness in left arm with a knot/lump where injection was given.
38 2021-01-26 injection site pain Tachycardia 120s-130s that lasted ~8-10 hours Other symptoms included fever, chills, body aches, hea... Read more
Tachycardia 120s-130s that lasted ~8-10 hours Other symptoms included fever, chills, body aches, headache, malaise, cough, chest irritation, pain at injection site, pain with movement of the affected arm. I received an influenza vaccine on 12/17/20 but do not know the manufacturer or any other details. If needed, please reach out to my PCP:
38 2021-01-26 pain of skin Took my shot at 1:00pm. Around 8:00pm, I started to have stomach cramps. At 1:00am the next morning ... Read more
Took my shot at 1:00pm. Around 8:00pm, I started to have stomach cramps. At 1:00am the next morning I started having chills and shaking which continued until 4am when I started having back cramps and arm cramps where I had my shot. I also felt feverish and had a very bad headache, so I took 600mg of ibuprofen. I went in to work that morning and had chills and my skin hurt when my clothes touched my skin. I continued to have a headache also. I was sent home by my boss at 12pm on 1/5/21 because I looked and felt so bad and slept through the afternoon and for 10 hours that night. The next day, I continued to take 6oomg of ibuprofen every 6 hours and still had a lot of fatigue. The day after I was tired but them remained symptom free.
38 2021-01-26 vaccination site pain headache; Right arm pain; fatigue; myalgia; This is a spontaneous report from a contactable healthca... Read more
headache; Right arm pain; fatigue; myalgia; This is a spontaneous report from a contactable healthcare professional (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on right arm on 12Jan2021 08:30 (dose number 2) at a single dose for COVID-19 immunization. Medical history included allergic rhinitis. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks and no other medication in two weeks. There were no concomitant medications. The patient previously took dexilant and had known allergies to the medication. The patient experienced right arm pain, fatigue, myalgia and headache on 12Jan2021 15:00. Treatment for the events included Advil 200 mg. The patient was tested for COVID (Nasal Swab) on 19Nov2020 which showed negative result. The outcome of the events was not recovered.
38 2021-01-26 injection site pain hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a s... Read more
hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021, she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-27 injection site warmth, injection site pain, injection site swelling, injection site pruritus 2 days after the injection she noticed itching around the site of the injection. The following morni... Read more
2 days after the injection she noticed itching around the site of the injection. The following morning she had burning and swelling and the arm is hot to the touch. The injection site was noted to be in her mid humeral area, below the deltoid.
38 2021-01-27 injection site pruritus, injection site swelling, injection site redness Dose #1 4 hours later tingling on my tongue and a strange taste almost metallic which lasted 5 days,... Read more
Dose #1 4 hours later tingling on my tongue and a strange taste almost metallic which lasted 5 days, I woke up on 12/31/20 with body aches, chills, headache, that is when I called the infectious disease nurse and they tested me for covid on the 31st and it was negative, I also approximately 2 weeks after the dose i developed a large red bullseye around the injection site and it lasted about 3 days. I had some itching and swelling at the injection site but the bullseye showed up later. The infectious disease team did not seem to find I needed any additional treatment. I self medicated myself with Tylenol, Benadryl Zyrtec OTC and Ibuprofen. There was about 4-5 days before the second dose when the symptoms cleared up.
38 2021-01-27 hives Hives
38 2021-01-27 vaccination site pain Intense abdominal cramps; chronic diarrhea; chills; feeling unwell; soreness in injection site; musc... Read more
Intense abdominal cramps; chronic diarrhea; chills; feeling unwell; soreness in injection site; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for self). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular (right arm) on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history included sciatica and Allergy: sulphur drugs. Concomitant medication included Multivitamins (unspecified). The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that initially after the vaccine (Jan2021; unspecified date), she experienced soreness in injection site and muscles aches, but these symptoms were mild. On 11Jan2021, the patient experienced intense abdominal cramps, chronic diarrhea, muscle aches, chills, and feeling unwell (also reported that these symptoms developed 5 days after vaccine). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The patient has been tested for COVID-19 post vaccination: Covid test type post vaccination was Nasal Swab, Covid test name post vaccination=Pcr; Covid test date=13Jan2021; Covid test result=Negative. The outcome of events was not recovered.
38 2021-01-27 sensitive skin Low-grade fever, chills, shivering, joint pain, skin sensitivity beginning 12 hours after vaccinatio... Read more
Low-grade fever, chills, shivering, joint pain, skin sensitivity beginning 12 hours after vaccination and lasting the following 18 hours.
38 2021-01-28 injection site pain 1/27/2021 - Freezing cold, shivering, full body muscle aches, shot site pain worse than before. Symp... Read more
1/27/2021 - Freezing cold, shivering, full body muscle aches, shot site pain worse than before. Symptoms continued through the night, requiring multiple blankets, layers of clothing, and figuring how to lay to avoid pain. 1/28/2021 - I had to call off from work. Exhaustion found; remained in bed all morning. Muscle pain worsened, but improved at about 6pm. Continued to be cold, but no shivering; improved at about 2pm. But started having cycles of cold/hot. Headache developed. 1/29/2021 - Returned to work late. Continued weak muscle pains, cold/hot cycles, and headache. All mild.
38 2021-01-28 rash macular, hives, itchy skin 9th Jan 2021-Hives-small: 10th Jan-hives-getting bigger: 11th Jan-17th Jan HIVES are worse, 18th J... Read more
9th Jan 2021-Hives-small: 10th Jan-hives-getting bigger: 11th Jan-17th Jan HIVES are worse, 18th Jan-hives-itchy-24th Jan 2021-worst blotchy-on her thighs & butt & forearms & elbows & her lip. 25th Jan-through today 29th January 2021-Saw her PCM 27th January-Benadryl, Zyrtec, Pepcid, hydrocortisone cream prescribed. Reminded-go to the ER if she feels SOB and gets worse. Sees her PCM-Monday 1st February 2021. Her Internal Medicine increased her allergy meds to the max she said. Still taking the Zyrtec & now 50mg Benadryl.
38 2021-01-28 injection site pain About 10 mins after receiving the first dose of Pfizer vaccine - I experienced chest pounding tachyc... Read more
About 10 mins after receiving the first dose of Pfizer vaccine - I experienced chest pounding tachycardia. They had me lay on the gurney and checked my pulse ox. My heart rate was 147 but my Sp02 100%. After about 30 mins or so it naturally came down with no medical interventions. Otherwise for the first dose my only other reaction was expected fatigue, injection site soreness and mild headache. Of note - I did go ahead and get my second COVID19 vaccine after consulting with medical professionals on 1/24 and did not experience any chest pounding tachycardia. Maybe mild tachycardia but I was also nervous due to the previous first inject reaction.
38 2021-01-28 rash macular Red blotchy swollen fingers and toes. Really sore arm and severe headache.
38 2021-01-28 itchy rash, rash papular, rash with redness itchy red bumpy rash in both my under arms and upper back area; itchy red bumpy rash in both my unde... Read more
itchy red bumpy rash in both my under arms and upper back area; itchy red bumpy rash in both my under arms and upper back area; itchy red bumpy rash in both my under arms and upper back area; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: unknown), via an unspecified route of administration on the right arm, on 16Jan2021 08:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant at the time of vaccination. Concomitant medication included acetylsalicylic acid (ASPIRIN), OTC allergy meds and unspecified multivitamins. Patient had an itchy red bumpy rash in both under arms and upper back area on 16Jan2021 20:00. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The events were considered non-serious.
38 2021-01-28 redness muscle and joint pain chills nausea headache sore, swollen and red arm
38 2021-01-28 vaccination site mass, vaccination site redness the vaccine was administered too far up and may have been given subcutaneously; developed a lump and... Read more
the vaccine was administered too far up and may have been given subcutaneously; developed a lump and redness in the injection site; developed a lump and redness in the injection site; Pain; This is a spontaneous report from a contactable nurse reporting for herself. A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), subcutaneous on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included unspecified medications (patient take medications). She received on Wednesday (on 13Jan2021) the second dose of the Covid vaccine and she developed a lump and redness in the injection site. In her opinion the vaccine was administered too far up and may have been given subcutaneously, the patient did not know if the injection was too far up while getting on the muscle. She would like to know if this was a side effect of the medication. The patient also experienced pain on 13Jan2021. The patient tried taking Tylenol for pain and took a dose of Motrin for pain, but that was it, the nurse assessed causal relationship between pain and COVID Vaccine was Yes. The outcome of the events was unknown.
38 2021-01-29 injection site discomfort 3 hours after vaccine I got diarrhea one time only. maybe about 8 hours later injection site was ver... Read more
3 hours after vaccine I got diarrhea one time only. maybe about 8 hours later injection site was very mild discomfort. Next day I was tired all day. All symptoms were over after 2 days.
38 2021-01-29 itchy skin, injection site pruritus Itching at injection site which spread to bilateral arms, legs and abdomen 4 minutes following injec... Read more
Itching at injection site which spread to bilateral arms, legs and abdomen 4 minutes following injection. 50mg Benadryl PO administered to patient by co-workers in LTC facility. HR 108, SaO2 98%, 5 min following injection. Dizziness began 11 minutes following vaccine injection. Patient laid in bed with elevated head. HR 80, SaO2 98% 15 minutes following injection. Tingling in lips mouth area began 30 minutes following vaccine injection. 911 called within 2 minutes of this and EpiPen 0.3mg dose administered at same time in left thigh. HR 94, SaO2 98% 32 minutes following vaccine injection. Ambulance arrived and patient stable, stating reduction in tingling of lip/mouth area and reduction in overall body itching. Patient taken to ER, based on history of allergy to fish, and patient's agreement to be seen in ER.
38 2021-01-29 redness Patient complaint of itching throat 15 minutes post getting vaccine. Redness noted right forehead ... Read more
Patient complaint of itching throat 15 minutes post getting vaccine. Redness noted right forehead Treatment 50 mg benadryl given right deltoid 5:48pm. Symptoms resolved in 10 minutes.
38 2021-01-30 redness Had shot on Wednesday. Didn?t even feel the injection. Took Tylenol for mild headache and soreness. ... Read more
Had shot on Wednesday. Didn?t even feel the injection. Took Tylenol for mild headache and soreness. Thursday felt fine. Friday had sore elbows and a noticeable mild flare up in my right pointer finger. (Normal for me this time of year to a flare up) by Saturday morning I felt pain in my elbows while doing yoga. By Saturday afternoon my elbow had swollen up and turned bright red - excruciating to the touch. Went to urgent care they said ?bursitis? and gave me prednisone- will follow up with rheumatologist Monday.
38 2021-01-31 injection site warmth, injection site hardening, injection site nodule Around the 2nd night/3rd morning, my arm began to swell. It was hot to the touch and feels like a k... Read more
Around the 2nd night/3rd morning, my arm began to swell. It was hot to the touch and feels like a knot. The knot and size keeps increasing for nearly a full week-still has a fever, hot to the touch, and very hard. The injection site is not sore. I'm now at day 17 and I still have a golf ball size knot that I'm very concerned about. It does not have a fever and the red swelling has gone away.
38 2021-01-31 redness Congestion started the night of 1/29/21. The next morning on 1/30/21 she started to get tingling in ... Read more
Congestion started the night of 1/29/21. The next morning on 1/30/21 she started to get tingling in both arms, facial swelling, face became tingling and flushed feeling. Slight tingling in tongue. She took Benadryl with mild relief. No shortness of breath or difficulty swallowing. Tingling of tongue and arms is gone but still has facial swelling and redness.
38 2021-01-31 sensitive skin Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations,... Read more
Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
38 2021-01-31 rash macular Pt. received vaccine at 6:10. After sitting about 5-6 minutes she started feeling faint. Red blotch... Read more
Pt. received vaccine at 6:10. After sitting about 5-6 minutes she started feeling faint. Red blotches started. Pt. was moved to treatment room where she started c/o tightness in her throat - pulse ox 98%, BP 140/88, pulse 120. Throat- no obvious obstruction. Heart tachy, lungs -CTA, red blotches on chest and arms. Pt. given Benadryl at 18:22, Epi given Left deltoid. EMS called. Pt. remained conscious after about 5 minutes and became more relaxed. Breathing became easier. EMS started IV. Pt. transported to Hospital, much improved, airway open. pt. reported tightness in throat nearly resolved as they left.
38 2021-01-31 injection site redness, injection site pruritus, injection site swelling, injection site pain Redness, itching, swelling, and mild pain at the injection site that didn't appear until 9 days afte... Read more
Redness, itching, swelling, and mild pain at the injection site that didn't appear until 9 days after the injection. Redness and swelling was about 2 inches in diameter. Symptoms improved with topical analgesic and resolved within 2 days.
38 2021-01-31 injection site pain Severe headache and injection arm ache developed in the evening after getting the injection. Treate... Read more
Severe headache and injection arm ache developed in the evening after getting the injection. Treated with Excedrin Extra Strength. Arm muscle ache lasted 3 full days - treated with acetaminophen. 48 hours after injection, woke up with a swollen armpit - lasted about 12 hours. Had small waves of nausea and soft stool/diarrhea between the 48th and 60th hours. Fatigue throughout the 72 hour period.
38 2021-01-31 rash with redness, rash Small red bumps spread out on chest and bottom of my back. A few on my arm and neck.
38 2021-01-31 vaccination site pain headache which was getting more intense; 26 hours later had a low grade fever at 100 degrees; body a... Read more
headache which was getting more intense; 26 hours later had a low grade fever at 100 degrees; body aches; chills; very sore arm at injection site; This is a spontaneous report from a contactable Other HCP (patient). This 38-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration at arm right on 10Jan2021 15:00 at single dose for covid-19 immunisation as healthcare worker. Medical history included headache. Concomitant medications were none. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) for covid-19 immunisation. The patient received the second dose of the vaccine on 10Jan2021, and on 15Jan2021 until today (18Jan2021) she had been experiencing headache which was getting more intense. It was very unusual for her. The patient had other symptoms initially that were more on the normal range. The patient stated the headache was not normal. The patient clarified her other symptoms as: 14 hours after the injection, experienced chills and very sore arm at injection site on 11Jan2021 at 5:00 am. 26 hours later had a low grade fever at 100 degrees and body aches on 11Jan2021 at 17:00. Headache began five days post vaccination. Headaches got more intense. Headache was quite bad yesterday (17Jan2021). None of her normal medications for headache had worked. The patient had headaches in the past, but not for the length of more than a day. The patient clarified she was referring to the Pfizer COVID-19 Vaccine. Headache medications that were not working for this headache included Norco, Fiorecet, Maxalt, and Advil 100mg (with Acetaminophen, Lot: DN7580, Exp: Jan23). Outcome of the event chills, very sore arm at injection site, 26 hours later had a low grade fever at 100 degrees, body aches was unknown. Outcome of the event headache which was getting more intense was not recovered.
38 2021-02-01 hives Immediately following the vaccination, she developed airway compromise, wheezing, hives. Was given I... Read more
Immediately following the vaccination, she developed airway compromise, wheezing, hives. Was given IM epinephrine, and Benadryl, taken to ED. Stabilized, discharged home on prednisone 50 mg x 5 days. Returns 2/2/21 with Bell's Palsy. Negative MRI imaging. Airway symptoms resolved. Discharged on prednisone and acyclovir.
38 2021-02-01 rash, itchy rash, rash papular, rash with redness Itchy Rash (red and raised bumps) on neck and face that has not resolved. Over the counter Benadryl... Read more
Itchy Rash (red and raised bumps) on neck and face that has not resolved. Over the counter Benadryl taken
38 2021-02-01 injection site warmth, injection site pruritus, injection site redness, injection site pain Pain and redness at injection site. Redness initially size of a quarter on day 1, 11 hrs after injec... Read more
Pain and redness at injection site. Redness initially size of a quarter on day 1, 11 hrs after injection and increased to the size of a silver dollar on day 2.5. Remained silver dollar size through day 5. Also swelling of arm 2 inches above injection site through it to 2 inches below. Warm to touch. Itchy near injection all lasting 5 days. Symptoms subsided by day 5. Treatment: Tylenol and Benadryl which were ineffective.
38 2021-02-01 rash Rash on entire trunk of body; This is a spontaneous report from a contactable physician (reported fo... Read more
Rash on entire trunk of body; This is a spontaneous report from a contactable physician (reported for herself). A 38-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3302, expiry date not reported), via an unspecified route of administration on 19Jan2021 08:30 at a single dose in the left arm for COVID-19 immunization. Medical history included penicillin allergy (rash as a child). The patient was not pregnant at the time of the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient had the first dose of BNT162B2 (Pfizer brand; lo EL1284) for COVID-19 immunization on 29Dec2020 08:30 AM, in the left arm. The patient did not receive any other medications within 2 weeks of vaccination and any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on entire trunk of body on 20Jan2021 20:00. No treatment received in response to the event. The event was reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event rash on entire trunk of body.
38 2021-02-01 injection site pain Vaccine was administered too high in the arm, directly under the shoulder blade. Site was very pain... Read more
Vaccine was administered too high in the arm, directly under the shoulder blade. Site was very painful within a couple hours after administration and required pain medication for several days. A few days after administration, noted "popping" in shoulder when moved in circular motion; no decreased mobility noted. 2 weeks after vaccination, the administration site is still painful to touch and shoulder still pops when arm is moved in circular motion, forward or backward.
38 2021-02-01 itchy skin generalized itching
38 2021-02-01 itchy skin, rash papular, skin spots papular rash with petechiae; papular rash with petechiae; itching; This is a spontaneous report from... Read more
papular rash with petechiae; papular rash with petechiae; itching; This is a spontaneous report from a contactable other hcp. A 38-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), first dose, intramuscular on 07Jan2021 single dose for covid-19 immunisation. Vaccine location was left arm. Medical history included drug hypersensitivity to pertussis vaccine, erytrhromycin, sulfacetamide. Concomitant medications included celecoxib (CELEXA), ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient experienced papular rash with petechiae on 17Jan2021, itching on 17Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Jan2021. The events outcome was unknown Information on the Batch/Lot number has been requested.
38 2021-02-02 injection site redness, injection site pain ARM Injection site sore red Muscle aches Joints sore Fatigue 24 hours
38 2021-02-02 injection site swelling, injection site warmth, injection site pruritus, injection site mass, injection site redness Lt deltoid swelled, got itchy, red, and hot for a couple hours. Better today but still has a lump by... Read more
Lt deltoid swelled, got itchy, red, and hot for a couple hours. Better today but still has a lump by site of injection.
38 2021-02-02 itchy skin, rash Report rash and itchiness all over day after vaccine given. Treatment Benadryl on day 3 : Outcome co... Read more
Report rash and itchiness all over day after vaccine given. Treatment Benadryl on day 3 : Outcome complete resolution of symptoms.
38 2021-02-02 itchy skin c/o generalized itching, denies SOB or mouth/throat itching, pt declined Benadryl
38 2021-02-03 redness, itchy skin Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and... Read more
Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and chest; Slight itching; This is a spontaneous report from a contactable healthcare professional (the patient). A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 18Jan2021 at 10:30 (at the age of 38-years-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient was allergic to penicillin. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685) on 28Dec2020 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ALERTEC), both for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021 at 11:00, the patient experienced bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching. Treatment was given when seen by paramedics with an emergency room visit which included a second dose of allergy medication. The clinical outcome of the events bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported events were likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering the plausible temporal relationship and clinical course of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-02-03 rash Mild Rash all over appear 10 days after vaccine; This is a spontaneous report from a contactable nur... Read more
Mild Rash all over appear 10 days after vaccine; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. EH9899, expiry date: not reported), intramuscular on 08Jan2021 08:30 at a single dose (first dose) on left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took cipro [ciprofloxacin hydrochloride] which she had known allergies. The patient experienced mild rash all over appear 10 days after vaccine (18Jan2021). The patient has no COVID prior vaccination and has not tested post vaccination. The COVID vaccine was administered in a hospital. She had no other vaccines received in four weeks and no treatment was received in response to the adverse event. The outcome of the event was not recovered.
38 2021-02-03 vaccination site pain diarrhea; go back and forth throwing up; feel nauseas almost every day; injection site started hurti... Read more
diarrhea; go back and forth throwing up; feel nauseas almost every day; injection site started hurting; Headache; when she's breathing she feel like her lungs are cold; she cannot breathe good; feels like they (lungs) were burning; felt like she had the flu; felt like she was hit by truck; she has not been feeling well/not felt very good/felt really sick; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on the left arm on 03Jan2021 14:00 at a single dose as precaution for working in the healthcare field. The vaccine was administered at the Long-Term Care for facility. Medical history included had trouble breathing due to asthma that was diagnosed at age of 16. Concomitant medications included amitriptyline taken from an unspecified date for 6 years for interstitial Cystitis and it helps her sleep at night. After she got it (vaccine), her injection site started hurting and headache on 03Jan2021 that there went away a couple of hours after getting vaccination. Sometimes when she's breathing she feel like her lungs are cold, she cannot breathe good, and feels like they (lungs) were burning on 03Jan2021. Also, it was reported that ever since she got a first dose of the vaccine she has not been feeling well/not felt very good on Jan2021. She goes back and forth throwing up on 05Jan2021, and feel nauseas almost every day on 04Jan2021. When she got it, for the last of these 2 days (Jan2021) felt like she had the flu and felt like she was hit by truck and she felt really sick. The patient goes back and forth having diarrhea on 18Jan2021. For the reported events injection site started hurting, headache, she's breathing she feel like her lungs are cold, she cannot breathe good, and feels like they (lungs) were burning, throwing up and feel nauseas, diarrhea; an ER or physician's office required and gave her Zofran. The outcome of the event injection site started hurting and headache was recovered; unknown for he has not been feeling well/not felt very good, felt like she had the flu and felt like she was hit by truck and felt really sick; and not recovered for the rest of the events.
38 2021-02-04 itchy skin Approximately 7:00pm, I began to experience itching from head to toe. No rash noted. Had a little bi... Read more
Approximately 7:00pm, I began to experience itching from head to toe. No rash noted. Had a little bit of throat scratchiness, took 50mg of Benadryl and two Tylenol pills for my arm soreness and went to bed. When I woke up the next morning it was resolved.
38 2021-02-04 itchy skin Itching that is still ongoing 1 week post vaccination that started 10 minutes after vaccination. I f... Read more
Itching that is still ongoing 1 week post vaccination that started 10 minutes after vaccination. I flushed initially, was dizzy, and then began itching to the head and neck. Itching eventually spread to the torso and legs and became generalized. I began taking benadryl 25-50 mg and continuing pepcid as needed afterwards. GERD also severely worsened and has waxed and waned. Itching overall has waxed and waned, but as soon as medications wear off, itching will very quickly return and is intense to the entire, head, neck, torso and upper extremities. I am also getting breakthrough itching as well even with higher dosages of antihistamines. I had to call out from work 2/5/21 today as a medical provider in primary due to the effects of the antihistamines. I called my allergy/immunology specialist on Tuesday 2/2/21 and he prescribed xyzal 5mg twice daily and hydroxyzine 25 mg at night. I saw him in the office yesterday, and after discussion, overall decided I should not receive the second dose of the vaccine, and when itching subsides and able to be off of antihistamines for 3 days we will do the PEG protocol testing, and in another 1-2 weeks (14-21 days after initial injection) we will do an IgG spike test to see if I developed antibodies.
38 2021-02-04 redness, itchy skin, hives face started itching; throat was getting dry; face was starting too itch and be red; hives after sec... Read more
face started itching; throat was getting dry; face was starting too itch and be red; hives after second dose of vaccine; This is a spontaneous report from a contactable Other HCP reported for herself. This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL1283, Expiry Date: 30Apr2021), via an unspecified route of administration on 18Jan2021 06:45 at single dose injected into left arm for COVID-19 immunisation. Medical history included asthma from 2010. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT EJ1685, EXP 31Mar2021.) on 18Jan2021 at 04:00PM, injected into her right arm for COVID-19 immunisation, uses salbutamol (ALBUTEROL, NDC: 6699301968, LOT: VE7L, EXP: Nov2021) inhaler as needed for asthma and took inhaled steroids, but nothing recent. The patient got the second dose of the vaccine at 06:45AM, and the hives began on the 21Jan2021, she noticed them about 06:20AM and she had to be at work at 07:00AM. She said she treated that with diphenhydramine hydrochloride (BENADRYL, 25mg LOT: P120108. EXP May2022, UPC: 193968051518) because her face started itching and her throat was getting dry, so she took BENADRYL 25mg this morning about 06:40AM. She says she took one dose of this by mouth, because it seems to make her sleepy and she had to work. She says she got to work and started working, and her face was starting too itch and be red, and her throat was super dry, this was at 07:20AM, so she took prednisone (NDC: 20603-5338-31, LOT 8675217, EXP Dec2020) 60mg by mouth. She says this was expired, but she still took it, it is in a dose pack that has a box that says distributed by (Company name). She says she took Prednisone 60mg, one time today by mouth. She says she has asthma so she keeps a prescription of Prednisone at home that her doctor writes so she can have it, she says with asthma she keeps Prednisone around. She says she also applied equate Hydrocortisone cream 1% (LOT: 0JT0306, EXP Aug2022) that she got over the counter to the hives topically. She says that the label for that says underneath anti-itch it says intensive healing that it is mixed with vitamins, chamomile and Vitamins A, C, and E. Equate Hydrocortisone cream 1% UPC: Unknown, the tube has a barcode with no number, it did have a box that she did throw away. She thought hives was medically significant, but it is not getting worse, it is worrisome, but she is improving with the medicine she used for treatment. The outcome of hives was recovering. The outcome of other events was unknown.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-02-04 injection site pain nose bleeds times 2, nausea, vomiting, diarrhea, upset stomach, abdominal pain, tiredness, pain at i... Read more
nose bleeds times 2, nausea, vomiting, diarrhea, upset stomach, abdominal pain, tiredness, pain at injection site.
38 2021-02-05 itchy skin, pain of skin, injection site rash, skin warm, injection site redness Red rash on arm where vaccine was given. Rash is splotchy and bumpy and has spread down from vaccin... Read more
Red rash on arm where vaccine was given. Rash is splotchy and bumpy and has spread down from vaccine site. Very hot to touch. Itchy and painful to touch. Started night after vaccine and got larger 2 days after. Also have pain in armpit on right side.
38 2021-02-06 injection site redness, injection site hardening, injection site pain HA which began approximately 20 mins after administration (0810 AM on 2/3). Localized injection sit... Read more
HA which began approximately 20 mins after administration (0810 AM on 2/3). Localized injection site pain began later that evening around 1700 (on 2/3).. Enlarged right supraclavicular lymph node noted around 1100 on 2/4 with increased arm pain (mostly located in shoulder and increased with movement). Localized injection site reaction noted as redness and a painful knot at same time. Right side of neck sore and tender-to-touch, but not able to palpate any other lymph nodes. As of this submission, Supraclavicular lyonnaise node still swollen, arm pain with movement (at shoulder) minimal , and injection site still painful with a knot.
38 2021-02-06 injection site reaction, injection site hardening, injection site swelling, hives, injection site pruritus delayed reaction - hard, raised, itchy welt at injection site. approximately two inches in diameter... Read more
delayed reaction - hard, raised, itchy welt at injection site. approximately two inches in diameter. lasted three days
38 2021-02-07 itchy skin Feverish, chills, headaches, nausea, dry mouth, and sleepiness the day after the Vaccine was taken. ... Read more
Feverish, chills, headaches, nausea, dry mouth, and sleepiness the day after the Vaccine was taken. Started out slowly late morning around 9am and got worse by the afternoon. Took Motrin to relieve symptoms and slept. The next day felt better but in the evening on 2/5/21 felt itchy starting from arms and neck. Then after about 10 min of itchiness in that area and started itchiness down to my stomach and legs. I took allergy medication prescribed by my physician: Cetirizine HCL 10mg tablet (1 tablet). No issues after that. Had some issue with the itchiness from the first dose around the 3rd-5th day after the first vaccine was given. Didn't take any allergy medications and had a tiny bit of dark circular spots on limps and torso but wasn't severe. Thought that was from something I ate, or clothes detergent, etc. so shrugged it off.
38 2021-02-07 redness, hardening, injection site reaction, skin warm For 3 days: injection site reaction, fatigue, headache, loss of appetite, arm soreness. Mild to mod... Read more
For 3 days: injection site reaction, fatigue, headache, loss of appetite, arm soreness. Mild to moderate. Day 7 - 9: Moderate injection site reaction: swelling, hot to touch, hard, 3.5 inch red circle, sore. On going headache.
38 2021-02-07 hives, itchy skin Pfizer-BioNTech COVID 19 Vaccine EUA----Hives, itching, rapid heart rate 120-140, rapid breathing, n... Read more
Pfizer-BioNTech COVID 19 Vaccine EUA----Hives, itching, rapid heart rate 120-140, rapid breathing, next morning 2/3/21 HA, body aches & nausea. Treatment day of with Benadryl 50mg PO X 2 doses 2 hours apart 2/3/21 Tylenol & Benadryl.
38 2021-02-07 rash, itchy skin RASH ON CHEST, UNDER CHIN AREA; SHORTNESS OF BREATH; INCREASED HR 109 ETC... DRY MOUTH; ITCHING ARMS... Read more
RASH ON CHEST, UNDER CHIN AREA; SHORTNESS OF BREATH; INCREASED HR 109 ETC... DRY MOUTH; ITCHING ARMS, LEGS CHEST, AND FACE. TOOK BENYDRYL AND ALBUTEROL INHALOR.
38 2021-02-07 rash rash, abdominal pain, nausea, vomiting, diarrhea
38 2021-02-09 vaccination site redness, vaccination site swelling Below injection site (by armpit)is pink slightly swollen tender to touch; Below injection site (by a... Read more
Below injection site (by armpit)is pink slightly swollen tender to touch; Below injection site (by armpit)is pink slightly swollen tender to touch; Below injection site (by armpit)is pink slightly swollen tender to touch; This is a spontaneous report from a contactable nurse (patient) reported that a 38-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number : EL9263) via an unspecified route of administration on left arm on 27Jan2021 13:30 at single dose for covid-19 immunisation at workplace clinic. Medical history included allergies to sulfa, nickel and latex. The patient's concomitant medications included prenatal vitamins within 2 weeks of vaccination. The patient previously received first single dose of bnt162b2 on 06Jan2021 01:45 PM via unknown route on left arm for Covid-19 immunization (Lot number: EK09231). On 29Jan2021, patient had below injection site (by armpit) is pink slightly swollen tender to touch. The events did not result in emergency room or physician visit. There was no treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient had been tested for COVID-19, patient underwent covid test type post vaccination nasal swab, rapids and PCR in 2021, all results were unknow. The outcome of the events was recovering.
38 2021-02-09 shingles, rash with redness, itchy skin, itchy rash I received my first Pfizer Covid-19 vaccine on January 19, 2021. I didn't have any immediate reacti... Read more
I received my first Pfizer Covid-19 vaccine on January 19, 2021. I didn't have any immediate reaction after receiving the injection, aside from a sore arm. I'd like to note that when I received the vaccine I was breastfeeding as I do not know if this contributed to my reaction. About two days after receiving the vaccine, on January 21, 2021, I noticed a red itchy rash underneath my left breast. I initially thought this could be a complication associated with breastfeeding known as Mastitis. By the weekend the symptoms had decreased around my left breast and I developed a strong itchy sensation on the left side of my back. On January 25, 2021 I noticed I had a red rash on the left side of my back, on my left side and on my left breast. On January 27, 2021, I contacted my dermatologist and made an appointment thinking I had a rash. On January 28, 2021 I went to see Physician Assistant. During this visit diagnosed with Shingles. I do not know if the Covid-19 vaccine lead to developing Shingles. I wanted to share my experience in case there were other patients who received the Covid-19 vaccine and developed Shingles as a rare side effect.
38 2021-02-09 injection site pain Site: Pain at Injection Site-Medium, Systemic: Other- Pain radiating from neck to deltoid "in a line... Read more
Site: Pain at Injection Site-Medium, Systemic: Other- Pain radiating from neck to deltoid "in a line." Patient believes immunizer had good technique and doesn't believe the shot was given too high on the arm. Medium; symptoms lasted 21 days.
38 2021-02-09 vaccination site swelling Swollen lymph nodes on Left underarm; Painful to move; Swelling at injection site; Low grade fever; ... Read more
Swollen lymph nodes on Left underarm; Painful to move; Swelling at injection site; Low grade fever; fatigue; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9263) via an unspecified route of administration on the left arm on 22Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa. Concomitant medication included atomoxetine hydrochloride (STRATTERA) and bupropion hydrochloride (WELLBUTRIN). On 23Jan2021 02:30 AM, the patient experienced swollen lymph nodes on Left underarm. Painful to move. Swelling at injection site. Low grade fever and fatigue day 2 and 3. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
38 2021-02-09 rash with redness, itchy rash, rash itchy rash started on neck; itchy rash started on neck and it had been itchy since. It still had red... Read more
itchy rash started on neck; itchy rash started on neck and it had been itchy since. It still had red marks left; itchy rash started on neck and it had been itchy since. It still had red marks left. It felt dry.; This is a spontaneous report from a contactable consumer reported for herself that a 38-years-old female patient received bnt162b2 (BNT162B2; brand=Pfizer, Lot number=EK5730) first dose, via an unspecified route of administration on 21Dec2020 11:00 AM at SINGLE DOSE at left arm for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium, vitamin d, estradiol, apoaequorin, colecalciferol (PREVAGEN [APOAEQUORIN;COLECALCIFEROL]), iron. The patient previously took codeine and experienced drug hypersensitivity. After receiving the first dose of Pfizer, a itchy rash started on her neck and it has been itchy since. It still has red marks left. When I feel it, it felt dry. The events reported as non-serious. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient then received second dose of Pfizer COVID 19 vaccine (Lot number=EJ1685) on 11Jan2021 10:00 AM at Left arm. Outcome of events was not recovered, no treatment received for the adverse event.
38 2021-02-10 rash, rash with redness Red rash noted to posterior and anterior trunk.
38 2021-02-10 itchy skin, redness, rash Thursday started extreme fatigue, headache, muscle aches. On Sunday started rash on chest, arms and ... Read more
Thursday started extreme fatigue, headache, muscle aches. On Sunday started rash on chest, arms and legs with itching in face and throat. Went to urgent care on Monday and received steroid cream for rash. Rash went away by Thursday, but came back on Saturday, then have had a light redness on and off since the following Sunday. Still had the fatigue, headache, muscles aches, but started the shortness of breath, chest pain with dry cough, nausea. Saw NP on Thursday and got prednisone for cough and shortness of breath. Felt better on Thursday but got worse over the weekend with increased shortness of breath, chest pain with cough and spotty vision. Saw NP on Monday and was sent to ER to rule out life threatening illnesses. Finished the prednisone on Monday.
38 2021-02-11 shingles Developed shingles on L hip 2 days after 2nd covid vaccination
38 2021-02-16 redness, itchy skin Burning and itching sensation when feet are warm/sweating. 2/14 toes became red and swollen, . Light... Read more
Burning and itching sensation when feet are warm/sweating. 2/14 toes became red and swollen, . Light chest cough previous week, possibly unrelated.
38 2021-02-17 vaccination site pain This is a spontaneous report from a contactable conusmer (patient). A 38-year-old female patient rec... Read more
This is a spontaneous report from a contactable conusmer (patient). A 38-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: 9L3248, expiry date: not reported), via an unspecified route of administration on 29Jan2021 12:15 PM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included migraines, reaction to soy, allergy to penicillin. The patient had no concomitant medications (as reported). Past drug history included estrogen medications which causes migraines and fatigue. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL0140) on 08Jan2021 03:15 PM at a single dose on the left arm for COVID-19 immunization (age at vaccination: 38-year-old). On 30Jan2021 12:45 AM (as reported), the patient experienced soreness in left arm, lasted 72 hrs; woke up after 12 hours with bad headache, muscle aches, chills, fever; headache lasted 36s hours, fever lasted about 36 hours, muscle aches ongoing after 72 hrs, chills still persistent, subside with Tylenol (As reported). After about 60 hours swelling in left arm pit lymph node to about the size of a golf ball, sore all down left flank; after 72 hours swelling in lymph nodes near pubic bone and on neck as well, swelling in arm pit lymph node is decreasing. The patient received Tylenol for chills. She did not receive any treatment for the remaining events. Outcome of the events was recovering. The reporter assessed the events as non-serious. Since the vaccination, the patient not been tested for COVID-19.
38 2021-02-18 itchy skin, rash, skin spots 1/29/21 had mild arm pain and low grade temperature for 24 hours. Headache for multiple days after v... Read more
1/29/21 had mild arm pain and low grade temperature for 24 hours. Headache for multiple days after vaccine. 2/13/2021 noticed rash, like heat rash, on legs bilaterally. Put on hydrocortosone cream and then area burned and got very painful. Employee took zyertec for itching. Swelling noted in both lower legs and feet. Lower legs and feet showed petechaie and purpura from knees to toes. On 2/15/2021 saw MD and prescribed steroid. Petechaie improving but area is still red/purple and itchy. Will follow up with a dermatologist.
38 2021-02-18 hives About 24 hours after both shots my skin broke out in hives (armpits, nape of neck, public area and m... Read more
About 24 hours after both shots my skin broke out in hives (armpits, nape of neck, public area and my face/ears felt swollen). A Benadryl helped everything go down .
38 2021-02-18 rash Developed a rash on my back about 48 hours post 2nd covid vaccine administration. The the rash then... Read more
Developed a rash on my back about 48 hours post 2nd covid vaccine administration. The the rash then progressed to my chest and within 5 days I developed 2 lesions on my anterior chest that I saw a dermatologist for who felt this was a fixed drug reaction from the vaccine. No new environmental factors. Did not develop rash following the first vaccine
38 2021-02-18 itchy skin Patient reports throat itching, anxious and was given Benadryl , patient felt better after 10 minute... Read more
Patient reports throat itching, anxious and was given Benadryl , patient felt better after 10 minutes.
38 2021-02-18 redness, rash Sudden onset of lip and face tingling, redness and rash to chest, flushed face and increased heart r... Read more
Sudden onset of lip and face tingling, redness and rash to chest, flushed face and increased heart rate
38 2021-02-18 rash, hives Within 10 minutes started with lump in throat chest discomfort. Progressed to coming, rash and hive... Read more
Within 10 minutes started with lump in throat chest discomfort. Progressed to coming, rash and hives. Given zofran, Epi, benadryl, Pepcid and solumedrol. All iv
38 2021-02-21 injection site warmth, injection site swelling, injection site rash, injection site pruritus Covid arm- rash at site of injection a couple days after it was given. Itchy, hot to touch, swollen.
38 2021-02-21 itchy skin Pt complained of extremity feeling warm internally, itching, and numbness.
38 2021-02-21 skin burning sensation burning in arm, and headache
38 2021-02-22 injection site pain I had headache and nausea for the rest of the day that I got the vaccine. After that I was fine. As... Read more
I had headache and nausea for the rest of the day that I got the vaccine. After that I was fine. As a result I didn't feel like doing anything but laying down. Also as expected, I had pain at the injection site.
38 2021-02-22 itchy skin Itching within 1 hour of vaccine. Has appointment with allergy to evaluate if she should get 2nd.
38 2021-02-22 rash with redness, redness On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really ... Read more
On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really read, red hard rash, my face turned very red, pain on my shoulder & neck, and very bad headaches, my work send me o the emergency room, & also I had hard time seeing everything was very hard to see. I felt very nauseas I couldn't eat for the first couple of days, a lot of body aches & felt very fatigue. In the emergency room they prescribed me Trimodal & Zofran. I had to miss 4 days of work it lasted about 7 days the first 4 days my symptoms were sever but by the 5th day it was getting better.
38 2021-02-22 skin burning sensation, redness, injection site redness, injection site swelling Within 30 minutes, I turned bright red - my face and my forearms. Not a rash or raised rash. It was ... Read more
Within 30 minutes, I turned bright red - my face and my forearms. Not a rash or raised rash. It was a deep red flushing. I took a dose of oral Benadryl it didn't go away. It felt like a sunburn. I had a headache starting at the back of my head. 1st and second day, I had pain in my joints. Not muscular pain. It came and went the joint pain - behind my left knee was hurting really bad and then it went away. Then my right wrist would start hurting and then it would go away, etc. The second day, the headache was more mild - like a mild pressure in my head. The redness was still there - the red face and red arms. My left arm at the site was cherry red and about the size of two inch circle and somewhat raised. The third day, my headache was worse. It was not like a normal headache but an overall pressure in head. Pink and a bit larger but didn't hurt as bad on arm- the redness continued for six days on my face. The headache lasted 14 days straight - Motrin, ice, heat and extra sleep was tried for treatment. On 15th day it started to let up. On 16th day, it was very mild headache. On the 17th day, it was a full blown headache again. Day 18 it was gone. On the second week, I had mild pain in my stomach and then that went away. On day 3, I had about an hour - twice that day - where I was short of breath and then it went away - it was just that day - about noon and at night. I took Benadryl and when I woke up that didn't happen again. Doctor called on day 12 - when my headaches weren't going away. He took some labs. My labs were normal except thyroid (and I already have a condition for my thyroid). Dr. gave me a medication for headache but I didn't take it - it had a possibility of making me tired and I didn't want to take it.
38 2021-02-23 rash Elevated blood pressure 1) 172/107 2) 156/92 (normal for her is around 127/85 per patient), wave of ... Read more
Elevated blood pressure 1) 172/107 2) 156/92 (normal for her is around 127/85 per patient), wave of fatigue, felt a lump in throat, rash across opposite arm and chest, felt heat sensation. Symptoms improved after 20-30 minutes of monitoring and patient went home with instructions to seek medical attention if symptoms begin to worsen.
38 2021-02-23 redness Patient experienced lip swelling, facial redness & swelling with tingling. Patient transported to E... Read more
Patient experienced lip swelling, facial redness & swelling with tingling. Patient transported to ER for further treatment.
38 2021-02-24 itchy skin CLIENT HAD ITCHING, NO HIVES VISIBLE AND NO AIRWAY PROBLEMS. CLIENT GIVEN BENADRYL 50MG THAT RESOLVE... Read more
CLIENT HAD ITCHING, NO HIVES VISIBLE AND NO AIRWAY PROBLEMS. CLIENT GIVEN BENADRYL 50MG THAT RESOLVED ITCHING. SHE TOOK AT SECOND DOSE AT 2100 LATER THAT NIGHT FOR ITCHING AND HAD RESOLVED COMPLETELY THE DAY AFTER.
38 2021-02-24 rash with redness, rash Red flat rash on trunk, neck, back groin. I first noticed about 36 hours after second dose. It could... Read more
Red flat rash on trunk, neck, back groin. I first noticed about 36 hours after second dose. It could have been there sooner, I was just so sick from fever/body aches, I would t have noticed. It progressively got worse by the end of the day so I finally took Benadryl before bed. The nurse told me to try not to take anything, but the night before my fever wouldn?t let up and I felt really bad so took Advil. The rash kept getting worse so I ended up taking Benadryl and it helped clear it up. It looked very drug allergy to me. Not raised, just red
38 2021-02-24 rash, shingles Shingles-rash/low grade fever. Started 2/21/2021
38 2021-02-25 shingles Developed shingles as an adverse reaction to the vaccination
38 2021-02-26 redness I received the shot at 2:50, at about 5pm I had a bad headache and I noticed my left ear was hot. By... Read more
I received the shot at 2:50, at about 5pm I had a bad headache and I noticed my left ear was hot. By 6pm I noticed my ear was extremely red and swollen.
38 2021-02-26 shingles Shingles, started 6 days after vaccine. Prescribed Valtrex.
38 2021-02-26 rash with redness, skin tightness, skin burning sensation Sunburn-like rash on face, neck, chest, back and arms. It also burns like a sunburn and my skin feel... Read more
Sunburn-like rash on face, neck, chest, back and arms. It also burns like a sunburn and my skin feels tight. This started at 7pm tonight and is continuing now, 40 minutes later.
38 2021-02-27 hives, redness Normal symptoms developed within 12 hours - fever, chills, headache, fatigue. But about 36 hours aft... Read more
Normal symptoms developed within 12 hours - fever, chills, headache, fatigue. But about 36 hours after the vaccine I woke up with an extremely swollen face, accompanied by redness and hives.
38 2021-02-28 hives Rapid Heart Rate, Flushing, Hives on upper body, Nausea, Dizzy, feeling faint - This reaction occurr... Read more
Rapid Heart Rate, Flushing, Hives on upper body, Nausea, Dizzy, feeling faint - This reaction occurred very quickly in approximately 5 minutes. EMT at site was not alarmed. My heartrate decreased, and after my waiting time was over, I went home. After getting home and sending pictures of rash and list of symptoms to an allergist, I was told to take a double dose of liquid Benadryl and a dose of oral steroids.
38 2021-02-28 redness tacchycardia, High blood pressue, redness on vaccine arm, mild flushing
38 2021-03-01 redness Redness and itching all over body. Warm/hot sensation.
38 2021-03-01 injection site pain severe headache beginning after a few hours and still occurring 26 hours after injection, minor inje... Read more
severe headache beginning after a few hours and still occurring 26 hours after injection, minor injection site pain beginning morning after
38 2021-03-02 injection site pain, injection site mass, injection site redness, injection site bruising First was a large 1.5 inch diameter, red welp at site. For the next 60 hours, experienced severe mig... Read more
First was a large 1.5 inch diameter, red welp at site. For the next 60 hours, experienced severe migraine and joint pain. Red welp at site eventually turned purple with a large 4inchx1 inchx0.5 inch deep indention into muscle tissue at vaccine site. Arm has a constant dull ache that worsens with use and on palpation at site with noted weakness.
38 2021-03-02 itchy skin Itchiness on her arms, legs and body. Feeling hot. Given 25mg Benadryl IM RD. Patient referred to ER... Read more
Itchiness on her arms, legs and body. Feeling hot. Given 25mg Benadryl IM RD. Patient referred to ER by NP.
38 2021-03-02 hives bad hives, wheezing, chest tightness, fatigue, slight headache
38 2021-03-04 redness 10 minutes after vaccine, patient experienced flushing to her face, chest, and L arm. Her initial vi... Read more
10 minutes after vaccine, patient experienced flushing to her face, chest, and L arm. Her initial vitals showed pulse Ox: 100%, HR: 123, BP: 138/82. Patient denies SOB, sore throat, or difficulty swallowing. On exam, she has some flushing of her face b/l and chest had some popular erythema. It was not pruritic and blanched. No evidence of urticaria. She did not have any rash involving her b/l arms, abdomen, and back. Her airway was patent, no stidor. She was given a benadyrl. After 20 minutes, her HR decreased to 101. Her rash on her chest improved as well as her facial flushing. Patient was advised to follow up with her primary care physician.
38 2021-03-04 injection site pain Pfizer-BioNTech COVID-19 Vaccine EUA 10:33 am: received vaccine 10:55am: left facility and began d... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 10:33 am: received vaccine 10:55am: left facility and began drive home 11:00-11:20: sudden entire face numbness (forehead, cheeks, nose, lips, chin?NOT tongue or inside mouth) 11:20-noon: numbness improves Noon-2:30pm: slightly dizzy/lightheaded, ?out of it,? brain fog 2:30 still slightly dizzy/lightheaded, ?out of it,? brain fog, sudden tiredness Felt tired the rest of the day. Sore arm around injection site. Felt completely fine the next day.
38 2021-03-04 injection site pain Tingly arm down to finger tips, twitch in muscles in. Legs, diarrhea, and nausea. Sore arm at locati... Read more
Tingly arm down to finger tips, twitch in muscles in. Legs, diarrhea, and nausea. Sore arm at location for two days.
38 2021-03-04 injection site swelling, bruising, injection site pain after receiving shot i had an headache later that day about 3pm. I took ibuprofen 800mg a,d went to ... Read more
after receiving shot i had an headache later that day about 3pm. I took ibuprofen 800mg a,d went to sleep. I woke up about 10:30pm that night feeling sluggish. That Sunday I woke up with the same headache not as bad and i took another ibuprofen 800. My arm was very sore and swollen at the injection site. On Monday, when i woke up my right armpit had swollen up and bruised rally bad. My lymph nodes in my armpits had also swollen and very tender to touch. I went to SCS clinic and they gave me some Cyclobenzaprine for muscle relaxation and told me to follow up with my PCP. I went to my PCP on 3/4/2021 and she prescribed me some Prednisone for swelling.
38 2021-03-04 redness face became hot & red, felt dizzy/light headed, went away after about an hour
38 2021-03-04 itchy skin, rash facial/neck itching-rash
38 2021-03-05 itchy skin Nearly immediate flushing of face and neck which mostly resolved. Minimal flushing present 1.5 hour... Read more
Nearly immediate flushing of face and neck which mostly resolved. Minimal flushing present 1.5 hours post-vaccination. Itching also present and ongoing.
38 2021-03-05 rash with redness, rash Swollen, red facial rash with bumps (looked similar to bad acne)
38 2021-03-06 redness Patient presented for her first dose of Pfizer covid-19 vaccination today. She had Covid in the fall... Read more
Patient presented for her first dose of Pfizer covid-19 vaccination today. She had Covid in the fall. She has had anaphylactic reaction to antibiotics in the past, was advised she should be evaluated for 30 minutes post vaccination today. She agreed, was seated in the front row of chairs, next to the EMS and RN Observer tables. This RN checked in frequently with patient throughout her 30 minute observation period, conversing throughout the wait time. She reported feeling anxious about the vaccine and potential for side effects. She had her husband drive her to her appointment today. Her earlobes and forehead were flushed red and dry, but her neck was without redness. She had even, regular respirations and was able to speak clearly without issue. RN reassured her that we were here, assessing for any changes and were available to help. After 15 minutes, patient stated her mouth felt dry. RN offered water, patient accepted. She was able to drink and swallow without trouble. Patient's coloring remained the same, but she reported feeling better. She was still able to converse without difficulty. At about 29 minutes, patient stated she was worried that something may happen after her 30 minutes was up, stated her tongue was starting to feeling thick. RN offered her additional observation with EMS, alerted them to the situation. Patient checked out with RN station and this RN walked her into the hallway for EMS evaluation. EMS helped patient out of her sweatshirt and mask. EMS noted lip swelling and increased redness in her face, neck, chest, earlobes. EMS obtained vitals and administered 50 mg benadryl IM in her right deltoid. Patient's husband came in from the parking lot. Patient declined solumedrol injection due to her diabetes. EMS advised patient she needed additional evaluation and she was transported to hospital via ambulance. Patient's husband followed in his car. VAERS report filed.
38 2021-03-07 injection site pain, pain of skin Day of injection: Foggy head, injection site pain, chills, fever, muscle aches, sensitive to touch (... Read more
Day of injection: Foggy head, injection site pain, chills, fever, muscle aches, sensitive to touch (lightly touching my skin felt like needles and washing my hair hurt my scalp). Day 2: Felt hungover, nausea, splitting headache, fever, muscle aches, sensitive to touch, lethargic Day 3: Sneezing (~60 + times), pain from lymph node in left armpit, dizziness, lump in throat, fever, lethargic Day 4: Sneezing, swollen and red eyelids, dizzy, lethargic
38 2021-03-07 injection site pain, skin warm, skin hardening, redness Morning of March 5th: started feeling pain at the injection site right arm deltoid. Evening of March... Read more
Morning of March 5th: started feeling pain at the injection site right arm deltoid. Evening of March 5th: Pain is still present. I started to rub the arm. My arm became swollen, red, hard, warm to touch, itchy and painful to move. Later that night, I also felt something in my left forearm. I started using a cold pack. Morning of March 6th: right deltoid has not changed. Now alternating between heat and cold on arm. Evening of March 6th: left forearm feels like a sore muscle after exercising. I began to flex my wrist to stretch the muscle. My left forearm then became swollen, red, hard, warm to touch, itchy and painful to move. Morning of March 7th: Went to urgent care. I was prescribed a cream and antibiotics and told to take an allergy pill. Morning of March 8th: Right deltoid has lessened is swelling, redness, pain and itchy feeling. I started to feel the sore muscle feeling in both calf muscles and right forearm. I did not stretch the muscle and it has not produced the same reaction.
38 2021-03-07 itchy skin, rash macular My skin started to become itch with red spots; My skin started to become itch with red spots; This i... Read more
My skin started to become itch with red spots; My skin started to become itch with red spots; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number and expiry date unknown), via an unspecified route of administration at the left arm on 13Jan2021 09:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient reported that her skin started to become itch with red spots on 30Jan2021 14:00. No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. The outcome of the events were recovering. Events were reported as non-serious. Information on the lot/batch number has been requested.
38 2021-03-07 itchy rash itchy rash all over my stomach by the end of the day it was on my legs, chest, back, neck and arms.;... Read more
itchy rash all over my stomach by the end of the day it was on my legs, chest, back, neck and arms.; This is a spontaneous report from a contactable other health care professional (patient, self-reported). A 38-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3246, expiry date was unknown), via an unspecified route of administration, in Arm Left, on 19Jan2021 at 17:00, as single dose for COVID-19 immunization. Medical history included Slight anemic and slight Vit. D deficiency. Concomitant medication included ethinylestradiol, levonorgestrel (VIENVA) as birth control (in two weeks of vaccine). Patient previously took sulfamethoxazole, trimethoprim (BACTRIM), ibuprofen (MOTRIN) and Ibuprofen; had known allergies with these medications. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19 post vaccination. Patient reported that day after vaccine (20Jan2021, 06:00) got a very itchy rash all over my stomach by the end of the day it was on my legs, chest, back, neck and arms. Events resulted in doctor or other healthcare professional office/clinic visit. Patient was prescribed anti-histamine and steroid cream. Outcome of the event was not recovered.
38 2021-03-08 redness, itchy skin, hives Pt. states that she received the covid vaccine at 13:40 pm on 3/09/2021. Around 14:30 on 3/09/2021 p... Read more
Pt. states that she received the covid vaccine at 13:40 pm on 3/09/2021. Around 14:30 on 3/09/2021 patient developed redness to both ears along with feeling flushed and sweaty. BP reportedly was in the 170s-180s/100s. Pt. was given benadryl at 14:35 pm. Pt. states that around 14:40 pm she developed hives to face and itching. Pt. states that she feels as though her symptoms are improving. Patient denies shortness of breath, denies trouble breathing, denies chest pain.
38 2021-03-09 redness, rash macular Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash app... Read more
Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs. The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
38 2021-03-10 hives, redness, itchy skin Itching hives welts red like a lobster almost immediately after I waited for the 30 mins and even t... Read more
Itching hives welts red like a lobster almost immediately after I waited for the 30 mins and even told EMS they said it?s normal
38 2021-03-10 injection site redness, injection site swelling, injection site warmth, injection site pruritus Redness, itching, warmth and swelling at injection site
38 2021-03-11 itchy skin Chest pain, shortness of breath, itching, tingling in the mouth
38 2021-03-11 redness I am not sure if this is typical, but it's been really scary and I'm not sure if I should get the 2n... Read more
I am not sure if this is typical, but it's been really scary and I'm not sure if I should get the 2nd dose now... about 7p on 3/11/21 I started noticing my Right hand was feeling cold/tingly/numb. By the time I went to bed it was feeling strange up to my right elbow. I woke up (3/12/21 about 6a) with both hands (mostly all my fingers) looking very white (like Raynaud phenomenon). My right hand to elbow still feels strange and seems most affected (shot was administered on Left deltoid). My right hand almost feels like I have a glove on (wetsuit material).. I've been trying to keep circulation to them by taking hot showers and rubbing them. They now seem more reddish and almost like chilblains might occur. They feel tingling. I have previously had chilblains in my feet when they were cold, but I've been good at managing and don't get that anymore. Never had it in my hands previously..
38 2021-03-11 injection site pain Stiff arm . Moderate soreness at injection site..
38 2021-03-12 hives, injection site hives Hives (chest, injection site), flushing. Evaluated by EMS-Cleared
38 2021-03-12 hives I developed hives that started with my hands, but spread to my arms, lips, and knees. It wasn?t impa... Read more
I developed hives that started with my hands, but spread to my arms, lips, and knees. It wasn?t impacted by OTC Benadryl and hydrocortisone cream, so I went to urgent care and was prescribed prednisone and an antihistamine
38 2021-03-14 rash, hives Approximately 3 hours following the vaccination, I started having hives/rashes across my body, start... Read more
Approximately 3 hours following the vaccination, I started having hives/rashes across my body, starting below my neck, chest, and moving to my arms and stomach and back area. Approximately 7 hours later, hives still remain.
38 2021-03-14 hives Hives reaction of bilateral forearms and bilateral legs posterior/anterior noticed the following mor... Read more
Hives reaction of bilateral forearms and bilateral legs posterior/anterior noticed the following morning post vaccine continued for 3 days until sought treatment at urgent care which they prescribed methylprednisone
38 2021-03-14 hives Pfizer-BioNTech COVID-19 Vaccine EUA Systemic , severe hives began three days after shot. Did not go... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Systemic , severe hives began three days after shot. Did not go away with Benadryl. Got a prescription for Prednisone, and the hives went away within 48 hours.
38 2021-03-14 itchy skin Shortly after vaccination complained of itchiness to face and throat. Symptoms progressed. Received ... Read more
Shortly after vaccination complained of itchiness to face and throat. Symptoms progressed. Received Benedryl 50mg orally followed by Epinephrine 0,3 IM. Transported to hospital
38 2021-03-15 injection site pain 1. Fevers 2. Chills 3. Body aches 4. Soreness at site of injection 5. Deliriousness 6. Extreme weakn... Read more
1. Fevers 2. Chills 3. Body aches 4. Soreness at site of injection 5. Deliriousness 6. Extreme weakness Symptoms Lasted for about 48 hours post vaccination time. Was pregnant at the of the second shot (4 weeks pregnant - 01/12/2021). Expected due date was 09/15/2021. Had a sound heartbeat at 8 weeks (02/11/2021). Lost the heartbeat at 12 weeks(03/03/2021). Had a natural miscarriage at 13 weeks (03/09/20201).
38 2021-03-15 itchy skin, hives Head ache, hives and itching that stopped after 4 hours. Tired, body aches
38 2021-03-16 injection site pain, injection site redness After the second vaccination, The first injection site became red like a bee sting. Both injection s... Read more
After the second vaccination, The first injection site became red like a bee sting. Both injection sites are red but the first one is now larger and red AFTER the second injection.
38 2021-03-16 hives, rash Hives/rash on underside of arm
38 2021-03-16 injection site pain, injection site swelling Pain/swelling in the injection site the evening of 2/26 and for a day or two after. Lightheadedness... Read more
Pain/swelling in the injection site the evening of 2/26 and for a day or two after. Lightheadedness/fatigue the evening of 2/26 and part of the day after. Some tenderness/soreness in underarm area of the same arm injected. This didn't start for probably a week or so and lasted for maybe a week. I am not 100% sure on the timelines for that, but I know it didn't start right away and I know it was gone by 2.5 weeks after the injection.
38 2021-03-17 skin warm Hot, painful, raised lump on left arm lasting over one week.
38 2021-03-17 injection site pain Injection Site Pain , Tiredness, Headache , Joint Pain , Sweating right after receiving the shot ... Read more
Injection Site Pain , Tiredness, Headache , Joint Pain , Sweating right after receiving the shot about 45 minutes later when it started and ended around 8 am this morning .
38 2021-03-17 itchy skin, rash Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Det... Read more
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: pt reports itching and rash within 15 mins after vaccine is given. Benadryl was given and feeling better but emotionally overwhelm due to possibly unable to receive 2nd shot
38 2021-03-18 injection site pain At 2 am diarrhea, upset stomach, slight arm pain at injection site. At 3 pm nausea and exhaustion, ... Read more
At 2 am diarrhea, upset stomach, slight arm pain at injection site. At 3 pm nausea and exhaustion, woken from nap at 10 pm, temperature taken (100.0 degrees Fahrenheit), shooting stomach pains, headache, neck pain and general aches in joints.
38 2021-03-18 injection site pain Low fever, chills, malaise, headache, severe pain at injection site (inability to move arm, lay on a... Read more
Low fever, chills, malaise, headache, severe pain at injection site (inability to move arm, lay on arm or press on it without 7 out of 10 pain). Pain in arm began at 1300 hrs on 3/17, fever noticed at 500 hours on 3/18.
38 2021-03-18 hives, rash Rash/hives on neck, chin, back of neck, upper chest area
38 2021-03-19 injection site pain, injection site swelling, itchy skin, injection site redness Itching, injection site pain, tiredness, fever, injection redness and swelling, nausea, feeling unwe... Read more
Itching, injection site pain, tiredness, fever, injection redness and swelling, nausea, feeling unwell
38 2021-03-19 itchy rash, rash with redness, rash Rash (red and puritic) on right side of neck/chest Immediately took Benadryl Rash resolved within 8 ... Read more
Rash (red and puritic) on right side of neck/chest Immediately took Benadryl Rash resolved within 8 hours
38 2021-03-20 itchy skin Extreme muscle pain, headache, itching
38 2021-03-20 vaccination site pain blackout/ I wasn't able to see him only hear his voice; panicking sensation; mild pain in the admini... Read more
blackout/ I wasn't able to see him only hear his voice; panicking sensation; mild pain in the administration spot; then I vomited; excessive heat coming out of my body like hot flash; fell on my face; like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat; This is a spontaneous report from a contactable consumer, the patient. A 38-years-old (also reported as 45 years old) non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, in the right arm on 01Mar2021 at 13:30 (at the age of 38-years-old) as a single dose, for covid-19 immunization. The facility in which the vaccine was given was Doctor's office/urgent care The patient had no known medical history or allergies. Concomitant medication were reported as yes but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 02Mar2021 04:00, the patient experienced blackout/ I wasn't able to see him only hear his voice (medically significant), panicking sensation, , mild pain in the administration spot, vomited, like excessive heat coming out of my body like hot flash, fell on my face, when my husband touched me it became worse I'm talking about the heat. The reporter explained on mild pain in the administration spot, but after I went to bed I woke up to use the restroom and suddenly I had blackout and fell on my face It was panicking sensation my husband rushed for help he was talking to me but I wasn't able to see him only hear his voice then I vomited and there was like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat and my eyes were widely open in a scary way. Body temperature was checked with a thermometer and it was 98.1. The patient went back to bed was feeling the same blackout sensation. Consumer stated she is a healthy person in all means and never had such thing before. The patient underwent lab tests and procedures which included body temperature: 98.1 on Mar2021. No treatment was given for the events. The clinical outcome of the events Blackout, Vaccination site pain, fell on face, panicking sensation, vomited, hot flash and Feeling hot was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
38 2021-03-21 rash, blister, shingles 24 hours after 2nd dose, chills, 30 hours fever 101, body aches, headache 12 days later hot sensiti... Read more
24 hours after 2nd dose, chills, 30 hours fever 101, body aches, headache 12 days later hot sensitive arm, 14 days 2 bumps headache fatigue 15 days several bumps and blisters. Day 19 Diagnosed with Shingles.
38 2021-03-21 pain of skin Fever reaching 102 the night of 3/20. On 3/21 my fever stayed at 100.4 after taking advil. Severe bo... Read more
Fever reaching 102 the night of 3/20. On 3/21 my fever stayed at 100.4 after taking advil. Severe body aches, chills, skin pain, and severe headache.
38 2021-03-21 injection site pain Patient described pain in right shoulder at the time of vaccination. She rated the pain a "5" on a 1... Read more
Patient described pain in right shoulder at the time of vaccination. She rated the pain a "5" on a 1-10 scale, with "10" being the worse pain. The vaccination site was examined and appeared normal. The injection site was appropriately placed. There were no acute signs of inflammation or allergic-type reaction. The patient was provided an ice pack to her shoulder and acetaminophen 650mg orally. Symptoms were relieved and she was released to home with her husband, who was the driver.
38 2021-03-21 hives, redness, itchy skin Received vaccine on 02/26/21. By next day developed L facial swelling, erythema, pruritis and c/o h... Read more
Received vaccine on 02/26/21. By next day developed L facial swelling, erythema, pruritis and c/o hives; Seen in local ER and given steroids. Unclear other treatment as records not available. Asked PCP to get and submit.
38 2021-03-21 rash with redness red dots in right legs appears on that evening, right leg hurt and can't walk normally ~30 hours af... Read more
red dots in right legs appears on that evening, right leg hurt and can't walk normally ~30 hours after short, and not getting better until now. Will go to see doctor if symptoms last.
38 2021-03-22 itchy skin During 1st dose (2/27/2021 lot En 6202) patient developed swollen lips starting on 2/28/21. However,... Read more
During 1st dose (2/27/2021 lot En 6202) patient developed swollen lips starting on 2/28/21. However, patient assumed it was due to a change in laudry detergent that masks were watched in the previous day). During the 2nd does, Sunday, March 21, 2021 the patient stared to have tingling in lips 3/21/21 the by 6:00pm on 3/22/21 the lips were swollen. Patient took 50mg of diphenhydramine at 8pm. On 3/23/21 the swelling was worse on the lips, cheeks swollen, and ears itching. Another 50mg of diphenhydramine at 6am. The swelling did not change and patient went to ER at 7:30am. Patient was given 10mg decamethasome, 50mg diphenhydramine, and 20 mg famotide at 7:54am. Doctor noted minor swelling in the throught. At 1030am patient was released. Meds helped swelling some but not all the way. ER doctor believes it us angioedema.
38 2021-03-22 itchy skin Patient complaining of tingling to chest and neck, mild itching, tightness to throat with swallowing... Read more
Patient complaining of tingling to chest and neck, mild itching, tightness to throat with swallowing and sips of water, and dizziness at 10:15. Blood pressure was elevated. At 10:21, dexamethasone 4 mg was given by mouth. At 10:24, patient noted dizziness upon standing. At 10:53, patient was ambulating in the hallway without dizziness and left symptom free.
38 2021-03-22 itchy skin Patient developed itching about 15 minutes post vaccination. She then developed chills after drinki... Read more
Patient developed itching about 15 minutes post vaccination. She then developed chills after drinking water.
38 2021-03-22 rash STRONG HEADACHE IRRADIATING TO EARS AND EYES. IT STARTED 24 HOURS AFTER THE INOCULATION AND IT HAS L... Read more
STRONG HEADACHE IRRADIATING TO EARS AND EYES. IT STARTED 24 HOURS AFTER THE INOCULATION AND IT HAS LASTED FOR MORE THAN 2 DAYS. SKIN RASH ON THE HEAD, NECK AND CHEST AREA; IT STARTED 36 HOURS AFTER THE INOCULATION AND IT HAS LASTED FOR MORE THAN 2 DAYS.
38 2021-03-22 itchy skin Started itching a few minutes after received the shot. Felt slight shortness of breath but wasn?t su... Read more
Started itching a few minutes after received the shot. Felt slight shortness of breath but wasn?t sure if I was having panic attack or reaction. Took Benadryl and used inhaler and that helped. Around 2pm started having cramps as id period was on but it?s not due for a week. Took advil, it helped. Around 5:30pm severe abdominal cramps, nausea, went to bathroom several times. Arm, neck and shoulder pain. Dizziness and just feel weird. If gets worse tonight will go to ER, if same or better will call doctor in the morning
38 2021-03-22 injection site swelling, injection site redness, injection site pruritus, injection site pain, injection site warmth, injection site mass Swollen red, itchy lump - Now gone Now having severe injection site/arm pain for last 3 weeks. I wo... Read more
Swollen red, itchy lump - Now gone Now having severe injection site/arm pain for last 3 weeks. I work in the health care field so I was able to get my vaccine early. I do not have any redness or lumps now. It is slightly warm to touch, but when pressed it seems to sink in some. It is a dull ache which keeps me sleeping on my back. It has not gotten any better. I will reach out to my primary soon.
38 2021-03-23 itchy skin (note: I had no reaction to the first dose) 13 hours after receiving my second dose I had been in b... Read more
(note: I had no reaction to the first dose) 13 hours after receiving my second dose I had been in bed for a couple of hours unable to get comfortable because I felt weird. That?s when my ankles and feet began to itch. I checked for mosquito bites, none were there but I noticed that my ankles and feet were swollen. I applied a lotion recommended eczema thinking my skin might be dry. Over the next hour the itching got worse and spread up my calves. That?s when I noticed that my tongue felt weird and kinda poofy. I?m used to occasional dry mouth due to my meds, but this was nothing like that. It freaked me out so I got up took Allegra hoping that on top of the Zyrtec I?d taken hours before would help. Since I was restless and desperately needed sleep I took 1/2 of a 15mg trazadone tablet. That did the trip. No itching and I was able to sleep. Now I?ve been in bed all day with flu-like symptoms, I?m miserable and I?ve missed work. Unless I awake tomorrow morning feeling magically better I?ll miss work again. The itching and swollen tongue really freaked me out, hence my report today.
38 2021-03-23 injection site pruritus, injection site redness, injection site swelling, injection site pain Five days after receiving the second Pfizer Covid-19 injection, I noticed that I had developed a lar... Read more
Five days after receiving the second Pfizer Covid-19 injection, I noticed that I had developed a large red swelling on my left arm where I received my injection. It is slightly itchy and moderately painful. Overall size is a circle with a 2-3inch diameter.
38 2021-03-23 rash, itchy skin Rash in various parts of the body. Mostly around joints. A lot of itching. It?s lasted several days.... Read more
Rash in various parts of the body. Mostly around joints. A lot of itching. It?s lasted several days. It hasn?t gone away.
38 2021-03-24 itchy skin, hives Hives the next day on left hand side of body. Approximately 10 of them. Could have happened the day ... Read more
Hives the next day on left hand side of body. Approximately 10 of them. Could have happened the day of vaccination but I didn't notice until I took a shower the next day. Only mildly itchy
38 2021-03-24 injection site pain Injection site pain Tiredness/fatigue Headache Muscle/joint pain Chills Nausea Feeling unwell Cou... Read more
Injection site pain Tiredness/fatigue Headache Muscle/joint pain Chills Nausea Feeling unwell Cough
38 2021-03-24 itchy skin Patient stated she began to feel itchiness all over her body. Patient stated she has severe allergic... Read more
Patient stated she began to feel itchiness all over her body. Patient stated she has severe allergic reactions to ?everything in the air?. Accompanied to paramedic tent. Further evaluation completed by paramedics.
38 2021-03-25 itchy skin, rash, redness 20 minutes after receiving the vaccine, my face felt very hot (but I thought this was because I was ... Read more
20 minutes after receiving the vaccine, my face felt very hot (but I thought this was because I was wearing a mask and in a large room that was stuffy with a lot of people). I left the facility 10 minutes later and in the car my face felt like it was on fire. When I arrived home, my husband noted that my face was very red. I also developed itching around where my clothes were tight (bra and underwear line). I looked in the mirror and my face was erythematous with a sandpaper like rash (similar to scarlatina). I did not develop a rash in the other areas I was itchy. I took Benadryl 50 mg. The symptoms did not worsen and improved some. Since that time, my face has continued to have a rough, sandpaper like feel and is pink. Yesterday evening it became red again and I took another dose of Benadryl 50 mg. Of note, I was told by 2 different providers to go to an Urgent Care yesterday, but I did not as my symptoms are only cutaneous.
38 2021-03-25 injection site pain Fatigue/extreme tiredness, sound sensitivity, pain at the injection site, brain fog (lack of mental ... Read more
Fatigue/extreme tiredness, sound sensitivity, pain at the injection site, brain fog (lack of mental acuity), dull persistent headache even after tylenol, aspirin, and ibruprofen,
38 2021-03-25 bruising Feb. 3, 2021 within first 4 hours of receiving injection I began to experience restless legs. Febru... Read more
Feb. 3, 2021 within first 4 hours of receiving injection I began to experience restless legs. February 6, 2021 I experienced an out of the ordinary nosebleed. February 21, I found a bruise on my right leg. February 26, 2021 my PCP did lab work and determine on March 2, 2021 that my platelet count was 73,000. Repeated lab test on March 3 with results returning March 5 with 33,000 platelets. Had a nosebleed on March 4, 2021. Admitted to Hospital March 5 with 30,000 platelets that fell to 29,000 after being admitted. Throughout February 3-March 5, continued to experienced leg pain that included weakness and tingling in legs.
38 2021-03-25 rash, itchy skin Severe rashes covering my entire body after 6 days of the second COVID-19 vaccine. The rashes are ge... Read more
Severe rashes covering my entire body after 6 days of the second COVID-19 vaccine. The rashes are getting worse daily and very itchy and swollen.
38 2021-03-25 hives minor tachycardia, chest pain, nausea, hives, headache
38 2021-03-26 injection site pain, injection site swelling, injection site pruritus I had very little soreness after receiving first vaccination shot. Then 9 days later, I noticed my a... Read more
I had very little soreness after receiving first vaccination shot. Then 9 days later, I noticed my arm was itchy at injection site. It is rather swollen but not red or hot to touch. My arm is very sore, feels like the muscle is sore & weak. Difficult to use arm and tender to the touch.
38 2021-03-27 rash 12 hours after injection- generalized body rash on torso, arms and legs- not on face.. Significant a... Read more
12 hours after injection- generalized body rash on torso, arms and legs- not on face.. Significant arm pain, arm pit pain. 48 hours post injection- generalize swelling of arm pit, with swelling to left pectoral and trapezoid muscles.
38 2021-03-27 injection site pain Immediately after the vaccine on 3/20/21, I had some injection site muscle soreness. Later that eve... Read more
Immediately after the vaccine on 3/20/21, I had some injection site muscle soreness. Later that evening around 8:00 p.m., I developed episodes of vertigo- several per hour. developed a fever overnight. The next day I was fatigued, achey, and continued to have vertigo. I slept most of the day. I continued to have episodes of vertigo and have been fatigued. My vertigo is getting worse and it is 8 days post vaccine.
38 2021-03-28 injection site mass Chills, huge injection site lump, muscle aches, dizzy, exhaustion, low grade fever
38 2021-03-28 shingles I had shingles 3 to 4 weeks prior to receiving my vaccine. Within 2 to 3 hours after the vaccine, I... Read more
I had shingles 3 to 4 weeks prior to receiving my vaccine. Within 2 to 3 hours after the vaccine, I felt a burning sensation on the left side of my forhead going up into my scalp and then the shingles rash appeared. I was put on antiviral medication. I also had to see an eye doctor because the shingles rash started to both my vision.
38 2021-03-30 redness, itchy skin, skin burning sensation Erythema on face, neck, arms, and hands; Burning sensation of skin; Itching of skin; Chest tightness... Read more
Erythema on face, neck, arms, and hands; Burning sensation of skin; Itching of skin; Chest tightness; This is a spontaneous report from a contactable consumer. A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 29Jan2021 13:15 as single dose for covid-19 immunisation. Medical history included drug hypersensitivity (allergies: Penicillin) and mast cell activation syndrome from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), montelukast sodium (SINGULAIR), ascorbic acid, quercetin (QUERCITIN) and omeprazole (OMEPRAZOLE) On 01Feb2021 16:45, The patient experienced erythema on face, neck, arms, and hands, burning sensation of skin, itching of skin and chest tightness. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of erythema on face, neck, arms, and hands, burning sensation of skin, itching of skin and chest tightness. The outcome of event was recovering.
38 2021-04-01 bruising blood work revealed platelet count 73,000; found a bruise on right leg near knee; an out of the ordi... Read more
blood work revealed platelet count 73,000; found a bruise on right leg near knee; an out of the ordinary nosebleed; restless legs; tingling sensations in my legs; This is a spontaneous report received from a physician (also the patient). A 38-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration, administered in Arm Right on 03Feb2021 08:30 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a workplace clinic. The patient medical history includes: Graves Disease, Lupus, O- Blood, RH-, allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at time of vaccination. Concomitant medication (reported as any other medications the patient received within 2 weeks of vaccination) included gabapentin taken for an unspecified indication, start and stop date were not reported. It was reported that (reported as within first 4 hours of vaccine) on 03Feb2021, the patient experienced restless legs. On 06Feb2021, the patient experienced an out of the ordinary nosebleed. From then until 21Feb2021, the patient would experience tingling sensations in my legs and then on 21Feb2021 found a bruise on right leg near knee. On 26Feb2021 blood work revealed platelet count 73,000; 03Mar2021 blood work revealed platelet count 33,000 (results received on March 5), significant nosebleed on 04Mar2021, hospitalized with 29,000 platelet count on 05Mar2021. The outcome of the event tingling sensations in my legs was recovered on 21Feb2021; for all other events was recovering. The treatment received was a steriod IV. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 4 days (from 05Mar2021 to 09Mar2021).; Sender's Comments: A causal relationship cannot be completely excluded between BNT162B2 injection and serious reported events only due to close chronological sequence. Other evidence or argument supporting a causal relationship cannot be established, so far. Otherwise, multi-morbid current conditions, and concomitant medication may have played as contributory factors to the serious reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-04-09 cellulitis, vaccination site pain, vaccination site itchiness Fever; chills; uncontrollable shaking; itching at injection site; pain in injection site; cellulitis... Read more
Fever; chills; uncontrollable shaking; itching at injection site; pain in injection site; cellulitis in right arm; Pregnant patient; This is a spontaneous report from a contactable consumer. A 38-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 38-years-old via an unspecified route of administration, administered in arm right on 25Feb2021 23:30 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and alprazolam (XANAX), both taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to Bactrim. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on the right arm on 05Feb2021 (lot number: EM9810) 11:00 for covid-19 immunisation. The patient experienced cellulitis in right arm, fever, chills, uncontrollable shaking, itching at injection site and pain in injection site on 26Feb2021 08:00. The mother reported she became pregnant while taking bnt162b2 on 25Feb2021 23:30. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 28Oct2021. Last menstrual period was on 15Jan2021. Therapeutic measures were taken as a result of the events which included treatment with cefalexin. The outcome of maternal exposure during pregnancy was unknown while the patient was recovering from all of the other events.
38 2021-04-09 vaccination site pain headache; blurred vision; couldn't stand without assistance; a band of numbness and tightness in my ... Read more
headache; blurred vision; couldn't stand without assistance; a band of numbness and tightness in my right arm that migrated down my arm from the site of the vaccination all the way to my wrist; a band of numbness and tightness in my right arm that migrated down my arm from the site of the vaccination all the way to my wrist; The site of injection also became very sore; a band of vice-like grip appeared around the lower part of my head, near my jaw, and it migrated up my head until it settled around my temples and eyes; faintness; strong vasovagal response; narrowing field of vision; rushing sound in ears; dizziness/severe dizziness; nausea; This is a spontaneous report from a contactable consumer (patient) reported for self. A 38-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 at 16:30 (Lot number: EP7533) on the right arm at single dose for COVID-19 immunization. Medical history included chronic lyme disease, hypothyroidism, allergies to cephalosporin antibiotics. Concomitant medications included levothyroxine, metronidazole, sertraline, clonazepam (KLONOPIN); that all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosis with covid-19 and patient had not been tested for covid-19 since the vaccination. Patient experienced a strong vasovagal response within 30 seconds of receiving the dose with narrowing field of vision, rushing sound in ears, faintness, dizziness, nausea; all of these symptoms improved after lying on the floor for 15 minutes. 2 hours later, a band of vice-like grip appeared around the lower part of patient head, near patient jaw, and it migrated up patient head until it settled around patient temples and eyes. The patient developed a headache, blurred vision and severe dizziness such that he couldn't stand without assistance. Patient also felt a band of numbness and tightness in his right arm that migrated down his arm from the site of the vaccination all the way to his wrist. The site of injection also became very sore. There was no treatment received for the adverse events. The outcome of events was recovering.
38 2021-04-15 injection site pain After the first dose, shortness of breath and heart racing, muscle pain at the site of the injection... Read more
After the first dose, shortness of breath and heart racing, muscle pain at the site of the injection Once in 3-4 days and for 2 weeks After second dose, after an hour, she had mild symptoms similar o her first dose, elevated heart rate, shortness of breath, felt lightheaded, palpitations, back pain, chest pain with the shortness of breath.
38 2021-04-22 shingles Fatigue, febrile, malaise times one week following vaccine. Developed shingles in right eye, and for... Read more
Fatigue, febrile, malaise times one week following vaccine. Developed shingles in right eye, and forehead one week post vaccine.
38 2021-04-26 itchy skin After initial dose of vaccine, eczema patch begun spreading up my arms (had only previously had it o... Read more
After initial dose of vaccine, eczema patch begun spreading up my arms (had only previously had it on my hands). Some mild lymph node swelling and general fatigue between the first and second vaccine dose. After the second dose I had severe lymph node swelling (up to a baseball size lump under my arm). Within a week of the second dose, I was treated for a sinus infection (though had no symptoms such as congestion) with antibiotics and steroids. After going off steroids, the eczema rash that had occurred after the first shot cropped up again and spread from my scalp to my knees and was extremely itchy. I also had painful, swollen lymph nodes from my ears to collar bone. I was not wheezy, but was coughing and had a tight feeling in my chest frequently. I had to do 2 rounds of steroids, increase antihistamine doseage, and begin a steroid cream (topical). I also had to decrease my immunotherapy doseage significantly because I had more severe responses to my injections. My skin finally cleared after about 4 months though I am still having to take increased medication dosages and decreased immunotherapy doseages.
38 2021-04-28 injection site pain Fatigue, headache, swollen lymph node in left armpit Soreness at injection site
38 2021-05-07 sensitive skin, skin irritation still have neck pain on left side where injection was administer; Vaginal labia manora are swollen a... Read more
still have neck pain on left side where injection was administer; Vaginal labia manora are swollen and skin is sensitive to touch; Vaginal labia manora are swollen and skin is sensitive to touch; I cannot walk or urinate since vulva is irritated; I cannot walk or urinate since vulva is irritated; I cannot walk or urinate since vulva is irritated; I cannot walk or urinate since vulva is irritated; ER diagnosis said I have a acquired disorder of genital organ.; Within 1.5 hr of vaccine started experiencing vaginal pain; Also experienced swollen lymph nodes under arm pit to enlarge; This is a spontaneous report received a contactable other healthcare professional, the patient. A 38-year-old [non-pregnant] adult female received the second dose of BNT162b2 (solution for injection; Lot unknown and expiry information not provided) as a single dose via unspecified route in the left arm on 20Apr2021 at 10:00 (at 38-years-old) for COVID-19 immunisation. Relevant medical history included Autoimmune Hashimoto's, penicillin allergy and known allergies to gluten, soy, dairy, wheat, malt and eggs. Concomitant medications sans therapy dates included levothyroxine sodium (TIROSINT) for thyroid; and liothyronine sodium (CYTOMEL) for thyroid. The patient previously received Covid-19 immunisation with first dose of BNT162b2 (Lot unknown) in left arm on 30Mar2021 at 10:00 (at 38-years-old). The patient denied COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 20Apr2021 at 12:00, reported as about one- and one-half hours after receiving the vaccine, the patient began to experience vaginal pain. The patient reported that she also experienced swollen lymph nodes under arm pit to enlarge, still have neck pain on left side where injection was administered. The patient explained that her labia majora are swollen, and the skin is sensitive to touch. The patient explained that she went to the emergency room (ER) because she could not walk or urinate as her vulva was irritated. The patient reported that the only thing that she did this week was get vaccinated and the ER diagnosis said she had an acquired disorder of genital organ and advised an obstetrical /gynecological consultation. The patient stated she never had this problem. The patient assessed the events serious (Disability or permanent damage). Relevant testing included a negative post-vaccination COVID-19 test via nasal swab on 20Oct2020 (as reported). There was unspecified treatment received for the events. The outcome of the events vaginal pain, swollen lymph nodes under arm pit to enlarge, neck pain on left side, labia majora are swollen, skin is sensitive to touch, vulva was irritated, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162b2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-05-09 skin spots, rash Developed a rash on legs- ended up in the emergency room. It was a petechial rash and upon further ... Read more
Developed a rash on legs- ended up in the emergency room. It was a petechial rash and upon further lab work and review, was diagnosed with Vasculitis.
39 2020-12-31 injection site pain, injection site reaction About 45 mins to an hour of receiving the vaccination , i felt a terrible pounding headache, I took... Read more
About 45 mins to an hour of receiving the vaccination , i felt a terrible pounding headache, I took Tylenol ES 500mg after felt relief but decided to sleep early. When I woke up this morning my injection site arm felt so painful and heavy and i had fevers between 103-101.5 though I took some tylenol 500mg every 6 hours. Tachycardic between 140-120bpm, i still have terrible headache, muscle & joint pains, extreme fatigue. Some dry cough but no shortness of breath.
39 2020-12-31 hives HIVES, SOB, THROAT CLOSING UP, WHEEZING
39 2021-01-03 injection site pain 12/29/20 ~1115 Received Pfizer COVID-19 vaccine. Only issue within the 15minute wait time is tendern... Read more
12/29/20 ~1115 Received Pfizer COVID-19 vaccine. Only issue within the 15minute wait time is tenderness in injection site. No adverse effects until 2 pm (dizziness, headache, fatigue, nausea, chills). Got home by 5pm. Worsened symptoms. Temperature hit 40C. Myalgias and joint pain started. Took Tylenol 1gm. Recurrent fever and chills. Symptoms did not get better. 12/30/20 started having pressure and stabbing chest pain. Went to ED for dehydration and nausea. Negative chest xray and troponin. COVID PCR also negative. As of 1/4/2021, writer is still experiencing same symptoms to a lesser extent.
39 2021-01-03 sensitive skin, injection site pain 2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dr... Read more
2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dry next morning and a couple hrs later it switched to increased salivation. The evening after injection I had a headache and just felt general malaise and fatigue, "run down". Difficulty sleeping that night due to body aches. HEadache, neck and lower back pain. Skin sensitivity when touched, bed sheets kinda hurt my skin. The bodyaches and malaise persisted through out day 2. Tylenol seemed to help. I slept better that night but woke up with night sweats, completely drenched. Arm pain at injection site on day 2 that resolved by mid day. Now 1 week later I have extreme fatigue yesterday and today. I do have hypersomnia but not even my adderall is helping. Not sure if this is related or not.
39 2021-01-03 injection site pain Around 24 hours post COVID vaccination into her left delt, she woke up with severe left shoulder an... Read more
Around 24 hours post COVID vaccination into her left delt, she woke up with severe left shoulder and neck muscle pain. She got in touch with her provider and was treated with valium and Celebrex. She reported about 2 cm swelling and fatigue. Thirty hours post vaccination, she had pain and swelling and could barely move. Dr. needed to take valium and Celebrex though for those 48 hours, and would have gone to the ER if they had not helped (the pain was that debilitating)
39 2021-01-03 injection site warmth, injection site swelling, injection site redness Erythema, swelling, warm to touch, around injection site. "tingling down arm to metacarpals per pat... Read more
Erythema, swelling, warm to touch, around injection site. "tingling down arm to metacarpals per patient"
39 2021-01-03 skin warm, rash macular, redness, hives, skin swelling Severe hives all over body- trunk of body fully covered in raised, red, blotchy, "firey" patches of ... Read more
Severe hives all over body- trunk of body fully covered in raised, red, blotchy, "firey" patches of hives; also, under armpits, over the shoulders, panty lines, behind knees, on and under breasts, back, onto neck and face (chin, lip area, eye brow area)
39 2021-01-04 injection site hives, injection site redness, injection site pruritus, injection site reaction, injection site swelling, injection site warmth Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcu... Read more
Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcutaneous but I did end up with an injection site reaction 2 days later to include a 2x3 inch red, itchy, raised, hot to the touch welt. Also had extreme dizziness, nausea, headache 2 days after injection. Dizziness, nausea, headache subsided after 24hrs however injection site reaction will go away and come back randomly. Seems to coincide with getting sick? Was fine up until 12/29 when I did end up getting sick to include headache, body aches, chills. I went to go get covid tested which was negative. I ultimately had a sinus/ear infection. However injection site reaction had gone away UNTIL I got sick on 12/29 then it showed up again and still have it as of today.
39 2021-01-04 injection site pain I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate ... Read more
I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate tiredness and body aches and headaches that were really bad until the 23rd that was sporadic. I felt feverish malaise really bad headache and body aches. I took Tylenol and Advil around the clock. on the 20th I also had very mild runny nose for 2 days. I went to get a covid test on the 23rd and it was negative. Symptoms resolved by the 25th I had no symptoms
39 2021-01-04 rash, blister, hives Left with nasty scab; Hand was wet from where she had scratched/busted open water blisters on her ha... Read more
Left with nasty scab; Hand was wet from where she had scratched/busted open water blisters on her hand; A rash and hives on that hand/rash unilaterally from the vaccination-side armpit to her breast and collar bone; A rash and hives on that hand; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at 14:00 at single dose for COVID-19 immunization. The patient medical history included breast cancer survivor, radiotherapy, psoriasis, pre-diabetic, hypertension, hypercholesterolemia and chronic obstructive pulmonary disease (COPD), all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported that: " on 23Dec2020 at 6:00, she woke up and her hand was wet from where she had scratched/busted open water blisters on her hand (same arm that she received the vaccine in). She also reported a rash and hives on that hand, and a rash unilaterally from the vaccination-side armpit to her breast and collar bone but nothing at injection site. She stated she took BENADRYL, symptoms subsided until BENADRYL wore off, then resurfaced, took more BENADRYL, then symptoms resolved. Symptoms lasted about 24 hours post injection, patient was left with a "nasty scab" on her hand from where she scratched the water blisters". The patient outcome of the events was recovered except for the "nasty scab" whose outcome was not recovered. Information on the lot/batch number has been requested.
39 2021-01-04 hives Patient works at County EMS. Shot given at 9AM and at approximately 915AM an EMT came and told me sh... Read more
Patient works at County EMS. Shot given at 9AM and at approximately 915AM an EMT came and told me she broke out in urticaria. She denied having this reaction to a vaccine before, but has had reactions to unknown substances a few times on the scene of calls and had to receive EPI and Benadryl. At 9:20 AM EMS personnel gave her one shot of Epi (with Epi Pen) and a dose of Benadryl. At 9:35 AM pt states she felt better. At 10 AM I checked on her one more time and she said she felt fine. She did ask for the ingredients in the vaccine. Showed her where to find on her paperwork. Advised she may want to get MD clearance before taking shot #2.
39 2021-01-04 rash Rash on form arms; This is a spontaneous report from a contactable healthcare professional. A 40-yea... Read more
Rash on form arms; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), at the age of 39-year-old, via an unspecified route of administration on 23Dec2020 at 02:30 at a single dose on the right arm for Covid-19 immunization. Medical history included diabetic type 1. Concomitant medications included insulin aspart (NOVOLOG) and levothyroxine sodium (SYNTHROID). The patient experienced rash on "form arms" on 28Dec2020 at 07:00. The patient received diphenhydramine hydrochloride (BENADRYL) as treatment for the event. Outcome of the event was recovering. The event was assessed as non-serious by the reporter.
39 2021-01-04 vaccination site pain, pain of skin burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had ho... Read more
burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had hot flashes; skin pain; joint pains; numbness of the whole arm; site pain; Headaches; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 39-years-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EJ1685, Expiration Date: 31Mar2021), via an unspecified route of administration in left arm on 28Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included obesity, asthma, hypothyroidism, vitamin D deficiency, multiple tendonitis, allergies to horses, cats, and dogs and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included mometasone furoate (ASMANEX), colecalciferol (VITAMIN D), levothyroxine sodium (SYNTHROID) and hydroxychloroquine, all received within 2 weeks of vaccination. The patient stated for hours post injection she had hot flashes but the worst was 12hrs after. She experienced severe muscle pain/ skin pain, joint pains, burning of eyes, Headaches, low grade fever, site pain, numbness of the whole arm, hot flashes followed by rigors. The events started on 28Dec2020 21:00. Treatment received for the events included Tylenol. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
39 2021-01-04 vaccination site pain in the arm where she received the shot, her hand and wrist go numb with pins and needles; in the arm... Read more
in the arm where she received the shot, her hand and wrist go numb with pins and needles; in the arm where she received the shot, her hand and wrist go numb with pins and needles; her arm is sore; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (left arm) on 20Dec2020 06:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other vaccine administered on same date of the Pfizer vaccine. The patient reported that she had the vaccine on Sunday (20Dec2020) and had a side effect that she didn't see listed. She stated that in the arm where she received the shot, her hand and wrist go numb with pins and needles, it was getting progressively less. She added that her arm is sore, but she expected that. She further stated that last night it just happened one time and it feels a lot better now. The patient asked if those were an expected side effect. The patent clarified that she received the COVID 19 vaccine on 20Dec2020 0600 in the left arm. On 21Dec2020 in the night at 0200 she woke up with pins and needles in her hand and wrist. It happened only when she was asleep and not moving her arm. She added that actually she feels it very faint off and on in the day but each night it has improved. She further clarified that the pins and needles are in her lower arm and wrist radiating up the arm. She added that she will be scheduled for the second dose. The outcome of event vaccination site pain was unknown, while the outcome of other events was recovering.
39 2021-01-05 itchy skin, hives, redness Erythema, itching and swelling wheal
39 2021-01-05 itchy skin PERIORBITAL AND SCALP ITCHING
39 2021-01-05 vaccination site pain extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left ar... Read more
extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left arm and up to behind left ear; pain radiating down left arm and up to behind left ear; neck tightness; mild headache; This is a spontaneous report from a non-contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 29Dec2020 10:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroid, PCOS (polycystic ovarian syndrome), sulfa allergies. Concomitant medications included unknown medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 29Dec2020 13:00, the patient experienced extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild headache. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild head ache was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
39 2021-01-06 rash 1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week... Read more
1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week after vaccine horrible migraines.
39 2021-01-06 skin warm Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and m... Read more
Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and my throat felt numb and a little swollen. I was still able to swallow and symptoms did improve after 15 minutes.
39 2021-01-06 hives, itchy skin Hives and Itchiness
39 2021-01-06 injection site pain Joint and Muscle pain, Fatigue, headache and soreness at injection site.
39 2021-01-06 rash fever, vomiting and rash
39 2021-01-06 injection site pain site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturban... Read more
site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturbance night of injection, elevated temp of 100deg (started at 0200 on the 6th and lasted for 24 hours), whole body aches esp neck and back pain (Started when temp started and has lasted after temp has stopped for a total of 31 hours). Migraine with sensitivity to light (started at 0400 on the 6th and lasted for 5 hours). Nausea and heartburn (started on the 6th at 1845 lasting 5 hours despite taking famotidine)
39 2021-01-07 rash 8:45 am 12/24 - severe rash on my left hand; and wrist; a mild rash went to my arm, chest and back h... Read more
8:45 am 12/24 - severe rash on my left hand; and wrist; a mild rash went to my arm, chest and back hairline and on my forehead. Benydryl - 25 mg. Went to ER after it spread at 11:00 am. Had another 25 mg benydryl and a pepsid 20 mg at ER. Rash lasted two days. Ended Dec. 26. It was also after I increased my seizure medicine on Monday 12/21. Received at 8:30 am today/8th - second dose of vaccine.
39 2021-01-07 rash macular At the 10-hour mark after receiving my second dose, I developed a blotchy rash on my chest and neck ... Read more
At the 10-hour mark after receiving my second dose, I developed a blotchy rash on my chest and neck (no discomfort or itching). At the 12-hour mark I developed severe chills and body aches and exhaustion which came on very quickly. At (approx.) the 13-hour mark my temperature was 103.3 but it never got any higher than that. For the next 24 hours my temperature hovered around 101-102.
39 2021-01-07 itchy rash, rash, redness Edematous, red, itchy rash all over body. It started on my face and bilateral arms and then went to... Read more
Edematous, red, itchy rash all over body. It started on my face and bilateral arms and then went to my neck, torso and legs.
39 2021-01-07 itchy skin, rash Fever/chills, left arm rash, itchy legs, myalgias. Tylenol/benadryl with good effect. No symptoms ... Read more
Fever/chills, left arm rash, itchy legs, myalgias. Tylenol/benadryl with good effect. No symptoms today.
39 2021-01-07 rash with redness, itchy rash Generalized itchy rash of red areas
39 2021-01-07 hives, itchy skin Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness. Pfi... Read more
Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness. Pfizer vaccine was given at 11:45 AM and reaction onset at 11:55. VS at 12:10: BP 132/67; HR: 100; O2 96%; Epi given at 12:22; Was taken to ED for observation. Patient has PMHx of RA and Asthma; Meds include Methotrexate, Advair, Omeprazole, Vit D; Allergies to PCN and Percocet; Had anaphylactic reaction to sucralose for fit test.
39 2021-01-07 rash, itchy skin Itchiness to multiple sites followed by rash and swollen eyes. Saw PCP placed on steroid course x 7... Read more
Itchiness to multiple sites followed by rash and swollen eyes. Saw PCP placed on steroid course x 7 days plus antihistamines.
39 2021-01-07 injection site redness, injection site pruritus, redness Itching/redness at injection site and up neck. 50mg Benadryl PO given. Rapid Response called and o... Read more
Itching/redness at injection site and up neck. 50mg Benadryl PO given. Rapid Response called and observed for 30 min. Discharged to husband's care.
39 2021-01-07 injection site pruritus, injection site redness, redness Itching/redness at injection site and up neck. Administered 50mg Benadryl PO . Staff called and ob... Read more
Itching/redness at injection site and up neck. Administered 50mg Benadryl PO . Staff called and observed for 30 min. Discharge to husband's care.
39 2021-01-07 injection site numbness, injection site tingling Left side numbness and tingling on same side vaccine administered. Mild swelling to arm and hand.
39 2021-01-07 rash Rash following first dose Second dose: rash, fatigue, body aches, fever
39 2021-01-07 injection site redness, injection site warmth, injection site pain Redness and swelling at the site of injection. The swelling was gradual and reached the size of a go... Read more
Redness and swelling at the site of injection. The swelling was gradual and reached the size of a golf ball. It was also warm and painful to touch. The pain has receded, but there is redness and it appears the swelling has just spread out over the arm, instead of out like a golf ball.
39 2021-01-07 itchy skin, hives UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left a... Read more
UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left and called staff and reported hives on upper and lower lips, lips warm to touch Narrative: Reported lip numbness c/ injection, reported to monitor no action taken. Employee left after 15mins. Employee reported hives on upper and lower lips, lips warm to touch ( text message) no action taken
39 2021-01-07 injection site swelling, injection site pain Vaccine was given above deltoid area, given in shoulder area. Right shoulder started to swell. Pain ... Read more
Vaccine was given above deltoid area, given in shoulder area. Right shoulder started to swell. Pain in right arm starting in shoulder and runs down the entire arm. Pain continues 1 week after receiving the injection. Mild swelling continues in right shoulder. Having numbness in right hand.
39 2021-01-07 injection site pain chills and body aches starting at 3:30 am lasting throughout the day. injection site soreness and ax... Read more
chills and body aches starting at 3:30 am lasting throughout the day. injection site soreness and axillary lymph node soreness
39 2021-01-07 hives hard time keeping blood sugar up; diarrhea; Hives; This is a spontaneous report from a contactable n... Read more
hard time keeping blood sugar up; diarrhea; Hives; This is a spontaneous report from a contactable nurse (patient's sister). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration, in Dec2020, at a single dose, for COVID-19 immunization. Medical history included diabetic. The patient's concomitant medications were not reported. Registered nurse called regarding COVID-19 vaccine. Her sister who is also a nurse got the vaccine before she did sometime in Dec2020. About 18 hours after receiving the COVID 19 vaccine, her sister got diarrhea and was having a hard time keeping her blood sugar up. The patient did not receive treatment for events diarrhea or the blood sugar. Patient also experienced hives and used Benadryl as treatment. Nurse stated that she has not talked to her; unsure if all of these events resolved or not but thinks the diarrhea was better. Outcome of the event diarrhea was recovering, while for other events was unknown. Seriousness of the events was not provided. No further information is provided. Information on the lot/batch number has been requested.
39 2021-01-08 itchy skin, redness One week after the injection my arm began itching. It is red, elevated and warm. Estimated date of... Read more
One week after the injection my arm began itching. It is red, elevated and warm. Estimated date of delivery: August 22, 2021
39 2021-01-08 rash, itchy skin tachycardia (130-140's), HTN 140/100's, near syncope, nausea, temp 99.0 within minutes. That evening... Read more
tachycardia (130-140's), HTN 140/100's, near syncope, nausea, temp 99.0 within minutes. That evening face rash and itching. Following day flu like symptoms as well as sore throat and congestion.
39 2021-01-09 injection site pain, injection site swelling My symptoms began approximately 14 hours after I received the vaccine. They started suddenly and in... Read more
My symptoms began approximately 14 hours after I received the vaccine. They started suddenly and included the following: -Intense dizziness that was also electric like and lasted 36 hours -Severe headache lasted 36 hours and mild for 48 hours -Fever last was intermittent for 48 hours. I only started recording it 24 hours after the vaccine was administered. My max temp was 101. -Nausea (1 episode of vomiting) lasted 36 hours -Muscle aches and joint pain lasted 36 hours -Extreme fatigue lasted 48 hours -Injection site pain and swelling are still present, but are now mild -Enlarged lymph node in armpit of the same arm that vaccine was administered. This was discovered about 24 hours after receiving the vaccine and is still present. It?s about 1 inch in diameter.
39 2021-01-10 itchy skin 10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours la... Read more
10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours later (03:30 the next day) fever up to 102, skin felt on fire all over my body, gi cramps, mild intermittent cough, myalgias, fatigue, extreme headache behind my eyes, occiput, and jaw pain, rigors.
39 2021-01-10 rash macular About 6hrs after administration, a flat red splotchy rash that resembled a mottling pattern appeared... Read more
About 6hrs after administration, a flat red splotchy rash that resembled a mottling pattern appeared on both arms from shoulder to elbow, I had moderate pain in all joints of both legs, and severe fatigue came on suddenly. I had to go to bed. The next morning, I had a headache, all joints felt mildly aches, moderate fatigue, and the splotchy rash remained on both arms still from shoulder to elbow. I took ibuprofen and rested in bed most of the day.
39 2021-01-10 injection site pain Arm pain at injection site. Fatigue and muscle aches for 24 hours. Swelling in armpit/lymph nodes on... Read more
Arm pain at injection site. Fatigue and muscle aches for 24 hours. Swelling in armpit/lymph nodes on injection site arm.
39 2021-01-10 injection site pain I had a slight headache while at work but was fine. I was home and was a little cold and my throat w... Read more
I had a slight headache while at work but was fine. I was home and was a little cold and my throat was scratchy. . Then about 9pm all of a sudden I started to get waves of chills. My hand were cold and my feet were frozen. I layered up with sweater and sweatpants to go to bed with a heavy comforter. I just could not get warm. About 1am, I woke up and put on my thick winter socks on because my feet were still frozen. I kept reminding myself to breathe in deeply. I checked my BPM and it was 80-82 and normally its about low 70s. I woke up about 5:30am and had a really bad headache, injection area and arm hurt, my body hurt and felt like I weighed several tons making me so slow. I didn't go to work the next day. My husband took my son to school and I took ibuprofen and went back to bed. Woke up again about 12:30 and felt better.
39 2021-01-10 injection site redness, injection site pain Post first dose of pfizer covid vaccine I had 2-3 days of intermittent headaches starting approximat... Read more
Post first dose of pfizer covid vaccine I had 2-3 days of intermittent headaches starting approximately 4 hours after dose and also 4-5 days of intermittent lightheadedness. I developed redness at injection site 4 days post dose and it is still present as of today even though it seems to be fading. Site is still painful to the touch.
39 2021-01-10 rash macular, redness, itchy skin Redness and itchiness to chest and lower neck around nose as well as minor tongue swelling. I was va... Read more
Redness and itchiness to chest and lower neck around nose as well as minor tongue swelling. I was vaccinated at 0710, waited my 15 minutes drove home ( 15 min) showered and then just before 9 am realized Inwas itchy. Checked chest area and had red blotches similar in pattern to an anaphylactic reaction I had a few years earlier to betadine exposure. The night of the vaccine Inwoke up with nasal congestion and rhinorhea, itchy ears and throat, watery eyes. This became worse throughout the following day where I continued benadryl 50mg q6 as well as alternating tylenol and ibuprofen for body aches
39 2021-01-10 injection site pain, injection site redness Redness, pain injection site, swollen armpit
39 2021-01-10 injection site swelling, injection site redness, injection site pain Swelling, tenderness and redness at the site of the vaccination
39 2021-01-10 hives Within an hour of the injection patient broke out in hives followed by numbness and tingling on the ... Read more
Within an hour of the injection patient broke out in hives followed by numbness and tingling on the left side of the face. Mild headache with body soreness started approximately 8 hours after injection and lasted for about 12 hours. Benadryl was taken to relieve the hives, Advil and Tylenol were alternated to relieve headache and body soreness. The numbness of the face was resolved about 12 hours after onset.
39 2021-01-10 rash fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, t... Read more
fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, took Tylenol and brought fever down to 101.7. Next day, woke up to sunburn rash on face, trunk to groin and legs, fatigue lasting all day. Next day 1/9, rash was still there, fever reached 100 lasting all day and fatigue.
39 2021-01-11 injection site pain Arm pain on the Injection site radiating to the left Armpit 3-4 hours after injection. Headache, ch... Read more
Arm pain on the Injection site radiating to the left Armpit 3-4 hours after injection. Headache, chills, Nausea, dizziness and fatigue for 2 days. January 10 is second covid vaccine date and January 12th woke up with a swollen left Armpit close to the breast. Left axillary lymph node swollen ? Not sure until I see a doctor. Will go to ER or Immediate Care to get it checked out.
39 2021-01-11 redness Chills, low grade fever up to 100.4, muscle aches, flushing red skin of neck and chest.
39 2021-01-11 hives, itchy skin Hives; Itching like a crazy person; This is a spontaneous report from a contactable other health pro... Read more
Hives; Itching like a crazy person; This is a spontaneous report from a contactable other health professional (Nurse Practitioner). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscular on 22Dec2020 at single dose on left arm for COVID-19 immunization. Medical history included heavy (Other medical conditions: Consumer stated, "No, I'm healthy other than being a little heavy"). There were no concomitant medications. Patient stated, "I filled out the 'app' after I got my Pfizer Vaccine the first one on 22Dec (Clarification Unknown) but I believe that I have been having a reaction to the vaccination and wanted some kind of guidance on moving forward with the booster and kind of what I should do?" The patient experienced hives and itching like a crazy person when she got the vaccine, 22Dec2020. Treatment in response to treatment, patient stated, "I have taken a lot. It's hives and itching like a crazy person. So I have been take Ibuprofen, and antihistamines like Claritin, Zyrtec and Benadryl." The outcome of the events was recovering ("I would say may be persistent, may be slight improvement"). The events were related to suspect drug as per reporter.
39 2021-01-11 injection site pain Injection site soreness and headache started on the evening of the day shot was given. The injectio... Read more
Injection site soreness and headache started on the evening of the day shot was given. The injection site pain was worse the next morning but Tylenol took care of the pain. The headache continued on despite tylenol & ibuprofen, and accompanied by nausea for 4 days, went away for 3 days then came back again until present.
39 2021-01-11 hives Pt. started having tachycardia immediately after vaccination and hives developed two hour after vacc... Read more
Pt. started having tachycardia immediately after vaccination and hives developed two hour after vaccination was given. Pt. took propanolol for tachycardia(already prescribed this medication by pcp) and bendryl for hives along with cold water. Pt. still experiencing hives today and just took loratadine and zaditor eye drops for crusty/itching eyes.
39 2021-01-11 injection site rash, rash, injection site pruritus, injection site redness Red, itch rash on forearm of the vaccinated arm, on 1/11/2021 the rash came back and was also on nec... Read more
Red, itch rash on forearm of the vaccinated arm, on 1/11/2021 the rash came back and was also on neck.
39 2021-01-11 injection site swelling, injection site pain Symptoms ? EE woke up at 01:00 with body aches, chills and HA. EE reports she went back to bed and ... Read more
Symptoms ? EE woke up at 01:00 with body aches, chills and HA. EE reports she went back to bed and when she woke up around 07:00 EE reports swelling and tenderness in L axilla region. EE reports complete resolution of body aches, chills and HA approximately 36 hours after vaccine. EE reports she continued with swelling and tenderness to L axilla region through today (1/12). Last day of work and shift - ? working today Home remedies? - rest and Tylenol (last dose Sunday 1/10 in the morning) Any improvement? ? improvement with time per EE Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns. EE verbalized back understanding and denied further questions at this time.
39 2021-01-11 injection site pain, injection site redness, injection site hardening, injection site warmth The day after the injection, the site became warm, red, sore and hard. Over time, the soreness has g... Read more
The day after the injection, the site became warm, red, sore and hard. Over time, the soreness has gone away, but the redness and hardness about a half dollar size around the injection site still remains. Today is day 11.
39 2021-01-11 vaccination site pain left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches... Read more
left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches; sick; she was shaking and shivering; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left deltoid), on 05Jan2021 at 11:00, at a single dose for COVID-19 immunization and preventative (prophylaxis). The patient has no relevant medical history and has no concomitant medications. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient is a registered nurse (RN) and received her first dose of the Pfizer COVID-19 vaccine yesterday. She had side effects from it. Last night (05Jan2021) she was kind of sick, she experienced fever and chills. She was in bed and trying to get cozy, but she was shaking and shivering, she does not know the exact time she experienced these since she was in bed. She checked her fever at 4am and it was 100.7 degrees Fahrenheit. She took Tylenol this morning and she does not think she has a fever as of now. She felt better and but she was still cold but not like last night. She still has body aches, but she is better now, and her body aches were worse when she had the fever. Now that her fever was down, she feels better, she does not know if she feels better since she took the Tylenol. She stated that none of her coworkers got sick. She just wanted to know if she will get better and if these were normal. She hopes she gets better since she never gets sick. She also reported that her left arm was really sore, there is no swelling. When she moves her arm, she can feel it was hurting and she was not able to sleep on her left side. She did not feel pain when she received the injection, she felt the pain after in her left arm. The events did not require emergency or physician visit. Outcome of the event body aches was not recovered, for event "left arm is really sore" was unknown, while for the remaining events was recovering. The reporter assessed the events as non-serious and related to the vaccine.
39 2021-01-11 vaccination site pain mild body aches; After first dose I only had pain at the injection site. After the second dose of th... Read more
mild body aches; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EJ1685, intramuscular at left arm from 16Dec2020 11:30 to 16Dec2020 11:30 at a single dose then (lot number: EK9231) via an unspecified route of administration at left arm from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history included supraventricular tachycardia. Concomitant medication included propranolol. After first dose on Dec2020, the patient only had pain at the injection site. After the second dose of the vaccine on 06Jan2021, the patient had pain at the injection site as well as mild body aches, chills and a fever of 101.5. The patient dis not received any treatment for the adverse events. The outcome of th events was recovering.
39 2021-01-11 skin discolouration swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch... Read more
swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch; swollen and stiff neck; swollen and stiff neck; chills; hot flashes; radiating pain of arms; numb fingers; blue hands and feet; joint pain; muscle aches; weakness; tirednes; lethargic; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EL0140, via an unspecified route of administration in the left arm on 04Jan2021 16:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, ADHD, overweight, asthma and known allergies to milk, cat, roach mix, dust mites and bermuda grass. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone and montelukast. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced swollen lymph nodes at neck and sore to the touch, swollen and stiff neck, chills, hot flashes, radiating pain of arms, numb fingers, blue hands and feet, joint paint, muscle aches, weakness, tiredness, and was lethargic, all on 04Jan2021 at 17:30 PM with outcome of recovering. The events were reported as non-serious with no treatment received. No follow-up attempts are possible. No further information is expected.
39 2021-01-12 skin irritation, itchy skin Dermatitis to left and right upper arms. Claritin and hydrocortisone used. No relief. Began getting ... Read more
Dermatitis to left and right upper arms. Claritin and hydrocortisone used. No relief. Began getting worse over the weekend. Zyrtec and hydrocortisone used and no relief. Now spreading to torso and lower arms. Very itchy. Primary care is starting prednisone. Claritin 1/8 zyrtec 1/11 hydrocortisone 1/8-1/11
39 2021-01-12 hives, rash papular, itchy skin I broke out into sever hives all over my legs. I noticed them around 5:00 pm, but I had been itchy p... Read more
I broke out into sever hives all over my legs. I noticed them around 5:00 pm, but I had been itchy prior to that I just did not notice the hives. Once I noticed the hives I took a shower, then contacted the pharmacy where I got the shot at, then took to Benadryl tablets. I also put some extra strength Benadryl cream on my legs as well. The hives were on both legs from the top to the bottom. Very red and blotchy in color, raised all over. I kept an eye on it through out the night and re-applied cream. I did not go to the hospital or the doctor.
39 2021-01-12 injection site warmth, injection site redness, injection site swelling Injection site was red and a little swollen the next day and has become increasingly larger. Today ... Read more
Injection site was red and a little swollen the next day and has become increasingly larger. Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; Injection site was red and a little swollen the next day and has become increasingly larger. Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; Injection site was red and a little swollen the next day and has become increasingly larger. Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; This is a spontaneous report from a contactable other HCP. A 39-yearsold female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included desvenlafaxine succinate (PRISTIQ), fluoxetine (FLUOXETINE), bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), etonogestrel (NEXPLANON) , ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), cyanocobalamin (VIT B12), and iron. On 05Jan2021, the patient experienced injection site was red and a little swollen and has become increasingly larger. 3 days later, on 08Jan2021, the injection site was red, warm, swollen, and about the size of a grapefruit. The outcome of the event was not recovered. Treatment included over the counter medications and ice. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported injection site reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-12 hives, redness, itchy skin Nearly one hour after administration of the vaccine, my hands became slightly tingly and itchy. When... Read more
Nearly one hour after administration of the vaccine, my hands became slightly tingly and itchy. When I woke the next morning, my hands were red, swollen and extremely itchy and had whelps around some of the joints. This progressed up into my wrists and elbows as the day went on. This is similar to the symptoms that I experience when I had fifths disease.
39 2021-01-12 injection site swelling, injection site pain Pain, swelling under arm that was injected with the vaccine. Pain and swelling was worse the next da... Read more
Pain, swelling under arm that was injected with the vaccine. Pain and swelling was worse the next day and the patient went to the ED to receive care. Tests were performed and she received morphine IV and Ketorolac IV. She was discharged to home after symptoms improved.
39 2021-01-12 redness Patient received her shot on 1/13/2021 at 11:20am. 12 minutes later she started getting very dizzy.... Read more
Patient received her shot on 1/13/2021 at 11:20am. 12 minutes later she started getting very dizzy. Her face was very red. She was extremely hot. Patient first bp was 140/101 with a pulse of 75. We continued to monitor her for the next 1 hour and 20 minutes until family arrived because she refused for us to call 911 because she did not want a bill. Every time we sat her up she was extremely dizzy. BP was 160/107 when she sat up on the bed. Her husband ended up taking her to the ER because she was still very hot and dizzy. Dr. was here. He listened to her breathing multiple times. There was no signs of allergic reaction. Patient reported a history of panic attacks.
39 2021-01-12 redness, itchy skin Pfizer-BioNTech COVID-19 Vaccine EUA - Lips tingled 2 minutes after injection, then moved to tongue.... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - Lips tingled 2 minutes after injection, then moved to tongue. Lips started to go numb along with tongue, face started to itch right after. Within 30 minutes of injection, eyelids were swelling, face and chest redness, whole body itching. Benadryl and Tylenol taken, symptoms were lessening within 1 hour of taking Benadryl.
39 2021-01-12 itchy skin, rash Rash, back neck, itching, two days after
39 2021-01-12 injection site swelling Site: Swelling at Injection Site-Medium, Systemic: Vomiting
39 2021-01-12 itchy skin, skin burning sensation at 7:30 pm Itching on arms and burning sensation on all over back with some swelling and tingling on... Read more
at 7:30 pm Itching on arms and burning sensation on all over back with some swelling and tingling on left top lip.. Took benadryl didnt subside then took 60 mg prednisone and it subsided.
39 2021-01-12 rash difficulty breathing, pale, rash on chest ,diaphoretic treated with diphenhydramine inj and dexame... Read more
difficulty breathing, pale, rash on chest ,diaphoretic treated with diphenhydramine inj and dexamethasone injection
39 2021-01-12 hives, injection site rash, redness, injection site redness, rash papular, itchy skin small red raised itchy rash at site of injection, hives to arms and legs within 24 hours. 2nd vaccin... Read more
small red raised itchy rash at site of injection, hives to arms and legs within 24 hours. 2nd vaccine worse. left arm redness and itching, general body itching, wheezing, entire upper left arm red and itching
39 2021-01-12 hives upper right lip swelling; hive on forearm above elbow on left arm; This is a spontaneous report from... Read more
upper right lip swelling; hive on forearm above elbow on left arm; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history included type 2 diabetes. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included metformin and glucosamine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 06Jan2021 17:00, the patient experienced hive on forearm above elbow on left arm then on 07Jan2021, the patient experienced upper right lip swelling. No treatment was received for the adverse events. Outcome of the events was unknown. The events were considered non-serious by the reporter.
39 2021-01-13 injection site hardening, injection site redness, injection site pruritus, injection site swelling, injection site warmth 1 week and a day after 1st dose was injected I started to feel swelling, itching, redness, and fever... Read more
1 week and a day after 1st dose was injected I started to feel swelling, itching, redness, and fever on the injection site. The swelled rapidly in an oval shape about 4 inches long and 2 inches wide. The lump lasted throughout the night. It was gone by the morning. I did not apply any type of treatment. It has not come back, and there have been no other symptoms.
39 2021-01-13 itchy skin Fever; chills; SOB; pain while taking a deep breath; swelling/itchiness left arm; swollen lymph node... Read more
Fever; chills; SOB; pain while taking a deep breath; swelling/itchiness left arm; swollen lymph nodes on left side under arm; generalized weakness
39 2021-01-13 itchy skin Itching of skin or arms, torso, legs. No hives or rash. Lasted 36 hours
39 2021-01-13 injection site pain Pain at injection site; body aches; headache; This is a spontaneous report from a contactable other ... Read more
Pain at injection site; body aches; headache; This is a spontaneous report from a contactable other health professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, on 06Jan2021 at SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included BNT162B2, intramuscular from 16Dec2020 to 16Dec2020 (1st dose; lot: PAA156051). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no concomitant medications. The patient experienced pain at injection site, body aches and headache. The outcome of event was recovering. No treatment received. No follow-up attempts possible. No further information expected.
39 2021-01-13 rash Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Ras... Read more
Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), intramuscular, in the left arm on 23Dec2020 at 10:30 AM (at the age of 39-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient previously took prochlorperazine edisylate (COMPAZINE) and experienced drug hypersensitivity. On 23Dec2020 at 8 PM, the patient experienced rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week. The events were reported as non-serious. The patient did not receive any treatment for the rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week. The clinical outcome of the events rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
39 2021-01-13 shingles Shingles under R breast Valtrex 1g tid x 7 days
39 2021-01-13 rash rash developed on 50% of her body; vomiting; nausea; headache; severe muscle aches; This is a sponta... Read more
rash developed on 50% of her body; vomiting; nausea; headache; severe muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 39-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via Intramuscular at left arm on 16Dec2020 at 01:00 PM at single dose (lot number: EK5730) for COVID-19 immunisation. Medical history was unknown. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), zolpidem tartrate (AMBIEN) and vitamins. The patient previously took dicycloverine hydrochloride (BENTYL), amlodipine and azithromycin (ZITHROMAX), all experiencing allergies. The patient experienced rash developed on 50% of her body, vomiting, nausea, headache, severe muscle aches 24 hours post vaccination on 17Dec2020 10:45 AM. The patient was treated with Benadryl, Tylenol, IM Solumedrol. The patient had Covid test post vaccination by Nasal Swab on 28Dec2020 and on 04Jan2021, both with negative results. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of all events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the rash and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-13 shingles shingles R s2 dermatone
39 2021-01-14 rash, itchy skin, hives Hives on face, shoulders and neck. Benadryl for the itching and hives
39 2021-01-14 vaccination site itchiness, vaccination site redness, itchy skin, redness Itching/redness at injection site; Itching/redness at injection site; Itching/redness up neck; Itchi... Read more
Itching/redness at injection site; Itching/redness at injection site; Itching/redness up neck; Itching/redness up neck; This is spontaneous report from a contactable pharmacist. A 39-year-old female patient (unknown if pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the Left arm on 06Jan2021 at 08:15 PM (at the age of 39-years-old) as a single dose for COVID-19 immunization, lot number: EL0142. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included anxiety and depression, coronary artery spasm, hyperlipidemia. Known allergies included latex allergy (anaphylaxis). Concomitant medications in two weeks prior to the vaccination included atorvastatin 20mg, isosorbide mononitrate 60mg extended release (ER), multivitamin, omperazole 20mg, sertraline 50mg and tizanidine 2mg for muscle spasm. On 06Jan2021 h 08:15 PM patient experienced Itching/redness at injection site and up neck. Oral (PO) diphenhydramine hydrochloride (BENADRYL) 50mg was given to treat the events. Rapid Response called and observed for 30 min. Discharged to husband's care. It was unknown if, since the vaccination, patient has been tested for COVID-19. Outcome of the events was unknown.
39 2021-01-14 rash RASH ON LEFT SIDE OF NECK FROM CHIN TO COLLAR BONE AND SWELLING OF LYMPH NODE AT EDGE OF COLLAR BONE... Read more
RASH ON LEFT SIDE OF NECK FROM CHIN TO COLLAR BONE AND SWELLING OF LYMPH NODE AT EDGE OF COLLAR BONE AND NECK.
39 2021-01-14 injection site redness, injection site swelling, injection site pain Slight joint pain in hips at 0700 on 1/9/21 progressing to severe pain in hips, back, and neck by 12... Read more
Slight joint pain in hips at 0700 on 1/9/21 progressing to severe pain in hips, back, and neck by 1200. Unable to move without pain rated 9/10. Tylenol and Motrin used PRN. Also noted fatigue and redness, swelling, pain at injection site. Called in to work 1/9/21 and 1/10/21. Pain continued rated at 8/10 until 1/12/21 when patient visited Urgent Care at 0930 . Provider gave 10mg oral Decadron and 30mg Toradol IM. Oral prednisone 50mg prescribed for 3 days starting 1/13/21. And continue regiment of tylenol, motrin, heat, bath for relief of symptoms. 1/13/21 patients lower back pain resolved. 1/14/21 patients left hip pain resolved. Right hip pain continues at same intensity, though somewhat more controlled with PRN tylenol, motrin, heating pad. Unable to work as of the submission of this report.
39 2021-01-14 skin hardening, redness Woke up on 01/10/2021 with tender left breast, under the breast was red and hard. Had to have area ... Read more
Woke up on 01/10/2021 with tender left breast, under the breast was red and hard. Had to have area drained and packed
39 2021-01-14 rash severe rash on breasts, neck, back and abdomen. No hives. No itching.
39 2021-01-16 itchy skin Immediately after the shot, felt very weak. took two tablets of Tylenol 500mg and went to bed. slept... Read more
Immediately after the shot, felt very weak. took two tablets of Tylenol 500mg and went to bed. slept for 9 hours. the next day began itching around the middle - stomach and back had to work so did not take anything for it. by the second day the itching was generalized. only temporarily relieved by application of cortisone - 10. the 3rd day I took cetirizine but it didn't seem to help much. the 4th day I took Benadryl and the itching reduced for the next few days. took another Benadryl on the 7th day. itching more localized to the stomach and back. Today, it came back to generalized again. from the scalp to the soles of the feet. I have to work so cannot take Benadryl at this time. Thought I would not need to see the Dr, hoping it would get better but as it stands today I will need to go see the Dr.
39 2021-01-16 itchy skin, hives Severe itching. Welts on chest and neck. Face itchy and flush. 4 days later I am still very itchy w... Read more
Severe itching. Welts on chest and neck. Face itchy and flush. 4 days later I am still very itchy with out allergy meds.
39 2021-01-16 injection site pain Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, head... Read more
Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, headache started 12/20/2020, 4 days post the vaccine. Went to the ER on the 12/21/20-12/22/20 due to increase headache, vomiting, diarrhea, dizzy, dry cough, weak/extremely fatigue. At the ER was given IV fluid, Zofran, Phenergan, tested for the Flu and Covid, also had blood work. All my blood work came back in normal ranges, FLU and Covid test were negative as well. Discharged from the ER with Phenergan, the next 3 days I had a migraine and had to be in a dark room with lights off, still very dizzy, tired, shortness of breath with movement, could not eat it made me nauseas. Called for follow up with PCP he then put me on steroids, for 7 days. 12/28 called PCP office again, was put on another round of steroid treatment with antibiotic. Was off work from 12/21/2020-01/02/21 due to the sickness post the vaccine
39 2021-01-17 skin irritation, shingles, rash Developed skin irritation and lymphadenopathy on left side of neck on evening of 1/14/21. Friday 15t... Read more
Developed skin irritation and lymphadenopathy on left side of neck on evening of 1/14/21. Friday 15th noted posterior left sided neck rash. Saturday 16th noted more pronounced lymphadenopathy and progression of irritating rash. Monday 18th made appointment with infectious disease, diagnosed with shingles (VZV), started on antivirals for treatment
39 2021-01-17 hives Patient received 0.3 mL of Pfizer COVID 19 vaccine into left deltoid at approximately 10 AM. Patient... Read more
Patient received 0.3 mL of Pfizer COVID 19 vaccine into left deltoid at approximately 10 AM. Patient was observed for 15 minutes to ensure no immediate adverse effects from vaccination. Patient later returned to vaccine clinic at 1:00 pm reporting hives on both the arms and chest, which shortly after progressed to swelling in the face. Patient reported having no shortness of breath and was immediately given 50 mg of diphenhydramine to help reduce allergic reaction. Due to severe swelling in the face, it was decided to call EMS and have patient transported to hospital to be observed and evaluated by medical provider.
39 2021-01-17 vaccination site pain Soreness at injection site Supraclavicular lymphadenopathy on side of injection; Soreness at injecti... Read more
Soreness at injection site Supraclavicular lymphadenopathy on side of injection; Soreness at injection site Supraclavicular lymphadenopathy on side of injection; This is a spontaneous report from a non-contactable other health care professional (patient). A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration (arm left) second dose on 08Jan2021 17:15 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included venlafaxine and levothyroxine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 for covid-19 immunisation (first dose, left arm, lot number EH9899). On 10Jan2021, the patient experienced Soreness at injection site, Supraclavicular lymphadenopathy on side of injection. No treatment was given. The outcome of the events was unknown. Facility where the most recent COVID-19 vaccine was administered was in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible. No further information is expected.
39 2021-01-17 hives reaction to Pfizer vaccine 39 y.o. female who presents with adverse reaction to receiving the COVID ... Read more
reaction to Pfizer vaccine 39 y.o. female who presents with adverse reaction to receiving the COVID vaccine. Patient described urticaria around her mouth, forehead, and anterior neck. She received IM epinephrine from staff at vaccination center (Occupational Health). She described significant improvement in her hives and urticaria. She denies ever having experienced any difficulty breathing or swallowing. She is otherwise in her usual state of health. Patient was discharged home with a prescription for diphenhydramine (25mg oral) and EPINEPHrine 0.3 mg/0.3 mL injection auto-injector. Possible link to vaccine could not be ruled out but the absence of systemic reaction is re-assuring. Tryptase was 5.4 ug/l (within normal limits). Other Labs are unremarkable. Pt was discharged home after observing for at least 2 hrs and she was advised to follow up with occupational health.
39 2021-01-18 itchy skin, rash 1/12/21 at 08:00 am patient started having intense itching throughout body which worsens at night, r... Read more
1/12/21 at 08:00 am patient started having intense itching throughout body which worsens at night, rash to abdomen, chest, bilateral lower legs. Pt. states that she started taking zyrtec which helped patient sleep better. Pt. states that symptoms have not resolved and are still there.
39 2021-01-18 hives I started out with hives on my lower legs, and then it spread up onto my arms and neck. I had a burn... Read more
I started out with hives on my lower legs, and then it spread up onto my arms and neck. I had a burning sensation.
39 2021-01-18 injection site pruritus, injection site warmth, injection site pain, injection site bleeding I started to feel fatigued and slightly dizzy at 12:30 pm the day I received the shot which would ha... Read more
I started to feel fatigued and slightly dizzy at 12:30 pm the day I received the shot which would have been about 5 hours after. I also had a low grade fever of 99.2 and arm pain at the injection site. That evening I began to have chills and fever, fatigue, body aches, and nausea. These symptoms lasted until the evening of 1/15/2021. Fever was on and off during that time and ranged from 99.2-100.7. My arm was very sore during this time and on 1/16/2021 it became very itchy and hot at the injection site so I took Zytrec which helped some with the itching and was like it this for about 24 hours then subsided. I did not go to the doctor because my symptoms were not severe and I recovered at home.
39 2021-01-18 itchy skin Metalic taste feeling of numbness in face with itching started within 25 min. I self medicated with ... Read more
Metalic taste feeling of numbness in face with itching started within 25 min. I self medicated with 25mg of Benadryl 15 min before injection because I had the same reaction to the first injection. However it did not prevent the reaction as I hoped it would this time. 30 min post injection I took another 25mg of Benadryl. Once med started working symptoms went away. At no time did I have difficulty breathing. By midnight I was woken by chills, body aches, and head ache (possibly secondary to the jaw clenching I woke up with too). I took tylenol which did not appear to help which is abnormal for me. Fever, chills, aches continued on throughout the night and through the day into the night. On tylenol fever was noted to be 100.6 Fahrenheit. I was finally able to sleep with tylenol and motrin by 10 pm on 18th for 8 hours. Next day temp was about 97.6 Fahrenheit with mild sweating throughout the day and aches had subsided. Today Jan. 19th all symptoms are gone.
39 2021-01-18 itchy skin, rash upper limb rash itch neck rash
39 2021-01-19 itchy skin, hives Day 2 broke out in hives and headache Day 3- starting feeling extremely fatigue Day started feelin... Read more
Day 2 broke out in hives and headache Day 3- starting feeling extremely fatigue Day started feeling sore, legs hurt, and muscle aches Today Day 9 legs still sore and muscle aches, and fatigue Taking Benadryl at night for itching due to hives and Tylenol for soreness and muscle aches
39 2021-01-19 injection site pain, injection site pain Fatigue, body aches, injection site pain, headache
39 2021-01-19 vaccination site warmth, itchy skin Immediately following vaccine dizziness, itching feeling in throat and skin, and nausea. A few hour... Read more
Immediately following vaccine dizziness, itching feeling in throat and skin, and nausea. A few hours after the vaccine, headache, nausea, dizziness continued. Face and left arm (vaccine site) felt like they were internally on fire. Twenty-four hours after the vaccine, flu-like symptoms (cold chills, fever, nausea, muscle aches to the point of it hurting to move, joint pain), headache, skin itching. Treatment was tylenol, ibuprofen, and benadryl.
39 2021-01-19 rash macular, itchy skin Itching started 01/13/2021 on left arm axillary area. Rash appeared 01/14/2021 to bilateral armpits,... Read more
Itching started 01/13/2021 on left arm axillary area. Rash appeared 01/14/2021 to bilateral armpits, bilateral antecubital areas, chest, below breasts, groin, bilateral wrists. Rash was blotchy and extremely itchy. Rash worsened and peaked on 01/17/2021. Rash is slowly going away
39 2021-01-19 itchy skin, redness Patient complained of itching and hands were red. Benadryl 25 mg po given and patient took her dail... Read more
Patient complained of itching and hands were red. Benadryl 25 mg po given and patient took her daily prednisone dose. After 30 minutes itching resolved.
39 2021-01-19 injection site redness, injection site pruritus, injection site warmth, injection site swelling Reddened raised area at injection site. Warm to touch. Itchy. Looks like hive. Did not get this with... Read more
Reddened raised area at injection site. Warm to touch. Itchy. Looks like hive. Did not get this with the first shot. Appeared sometime after shot but after 8 hours. Unsure of exact timing because I went to sleep and woke up with it at 0200.
39 2021-01-19 itchy skin itching
39 2021-01-20 injection site pain I received my second covid 19 vaccine on 1/18/21. I was 7 weeks pregnant at that time. About 14 ho... Read more
I received my second covid 19 vaccine on 1/18/21. I was 7 weeks pregnant at that time. About 14 hours after receiving the injection, I developed a fever of 100.4 accompanied by feeling unwell like I had the flu. Symptoms included local pain at the injection site, chills, malaise, headache, joint pains and fever with temp max of 102.6 at about 26 hours post vaccine. Tylenol 1000mg taken. Then I slept until the next morning. Symptoms improved by 36 hours post vaccine. Afebrile but feeling tired following throughout the next day.
39 2021-01-20 itchy skin Itchiness on b/l legs- 50mg IM benadryl given in R arm, vitals taken: 99%O2, HR 93, Temp 37.1, BP 13... Read more
Itchiness on b/l legs- 50mg IM benadryl given in R arm, vitals taken: 99%O2, HR 93, Temp 37.1, BP 136/85. Pt monitored for 1 hour. Pt denies rash.
39 2021-01-20 vaccination site redness, vaccination site warmth, vaccination site swelling, vaccination site pain Local injection site redness swelling heat and pain/local site is very painful and still red; Local ... Read more
Local injection site redness swelling heat and pain/local site is very painful and still red; Local injection site redness swelling heat and pain; Local injection site redness swelling heat and pain; Local injection site redness swelling heat and pain/local site is very painful; headache; extreme fatigue; diarrhea; This is a spontaneous report from a contactable Nurse (patient). A 39-year-old female patient received the second dose of BNT162b2 (Lot number: EL1284), intramuscular in left arm on 08Jan2021 15:00 at single dose for covid-19 immunization. Medical history included Hemeplegic migraines, wolff-parkinson-white syndrome (wpw), hypertension (htn), known allergies: Penicillin (PCN) and Sulfonamide (sulfa). The patient's concomitant medication was unspecified product. The patient previously received the first dose of BNT162b2 (Lot number: EH9899), at the age of 39-year-old, intramuscular in left arm on 18Dec2020 15:00 at single dose for covid-19 immunization. The patient experienced local injection site redness swelling heat and pain. Also noted was headache, extreme fatigue and diarrhea. But local site is very painful and still red day 3. The events were occurred at 12:00 on 09Jan2021. The patient did not receive the treatment for the events. The patient was not pregnant. The outcome of the events was recovering.
39 2021-01-20 injection site pain, injection site swelling Pain and swelling at injection site same day, next day 8/10 headache, fever 102.5, lightheadedness, ... Read more
Pain and swelling at injection site same day, next day 8/10 headache, fever 102.5, lightheadedness, profound fatigue, nausea, body aches which caused me to miss work
39 2021-01-20 itchy skin Patient began to have extreme itchiness in both arms and developed a rash on inner aspect of left el... Read more
Patient began to have extreme itchiness in both arms and developed a rash on inner aspect of left elbow within 10 minutes of vaccine. Patient was given 50mg Benadryl IM. Her itchiness and rash resolved after 40 minutes.
39 2021-01-20 itchy skin Patient with a history of having a rash and itching after receiving the flu vaccine. She stated she... Read more
Patient with a history of having a rash and itching after receiving the flu vaccine. She stated she discussed with her physician and he instructed her to get the covid-19vaccine. Received the vaccine. Received the vaccine and was sitting in observation and started to "feel itchy" at 1036. Denies difficulty breathing, did state that "her throat feels scratchy, and feeling a panicky" 1040 wheeled to ED, Checked into room for treatment.
39 2021-01-20 itchy skin Pt reported b/l itchy legs, pt was brought to observation room, given 50mg benadryl IM, vitals taken... Read more
Pt reported b/l itchy legs, pt was brought to observation room, given 50mg benadryl IM, vitals taken, O2 99%, HR 93, Temp 37.1, BP 136/85
39 2021-01-20 vaccination site redness, vaccination site swelling flu-like symptoms; Mainly flu-like symptoms such as chills, body aches, fatigue, headache; Mainly fl... Read more
flu-like symptoms; Mainly flu-like symptoms such as chills, body aches, fatigue, headache; Mainly flu-like symptoms such as chills, body aches, fatigue, headache; Mainly flu-like symptoms such as chills, body aches, fatigue, headache; Mainly flu-like symptoms such as chills, body aches, fatigue, headache; Feeling exhausted; Very swollen at injection site with redness; Very swollen at injection site with redness; Enlarged lymph nodes on right axilla with pain in left axilla; Enlarged lymph nodes on right axilla with pain in left axilla; This is a spontaneous report from a contactable Nurse (patient). This 39-year-old female Nurse (no pregnant) received the second dose of BNT162B2 (lot number=EL 1284) Intramuscular on 08Jan2021 05:45 PM on Left arm for covid-19 immunization. Medical history was High Blood Pressure, Depression. Concomitant drug included Labetalol, Lisinopril, bupropion hydrochloride (WELLBUTRIN). Past drug was the first dose of BNT162B2 (lot number=EH9899, vaccine location=Left arm) Intramuscular on 18Dec2020 01:30 PM. Patient experienced Mainly flu-like symptoms such as chills, body aches, fatigue, headache. Feeling exhausted. Very swollen at injection site with redness. Enlarged lymph nodes on right axilla with pain in left axilla on 09Jan2021 01:30 PM. Outcome of the event was recovering. No other vaccine in four weeks. No treatment. No covid prior vaccination. No covid tested post vaccination. Follow-up attempts are completed. No further information is expected.
39 2021-01-21 injection site pain -fever of 102.8 -body aches -pain under injected arm -chills -tired
39 2021-01-21 rash, itchy rash Extreme pain in entire L UE, nausea, fatigue, chills, hot flashes, headache, dizziness, brief and mi... Read more
Extreme pain in entire L UE, nausea, fatigue, chills, hot flashes, headache, dizziness, brief and mild SOB, itchy rash over entire torso worse on L side. Pain in UE gone in ~30 hours from injection, headache from 12 hours to 36 hours, rash 30 hours to 54 hours.
39 2021-01-21 injection site pain Headache/congestion nausea diarrhea body aches bone ache extreme fatigue very painful arm At inject... Read more
Headache/congestion nausea diarrhea body aches bone ache extreme fatigue very painful arm At injection site
39 2021-01-21 injection site swelling, itchy skin I noticed the night of 1/21/2021 that my arm was itchy. Looking at it there was a red raised bump at... Read more
I noticed the night of 1/21/2021 that my arm was itchy. Looking at it there was a red raised bump at the injection site that had not previously been there. Since having the vaccine the only other effect I had was arm soreness the day of and day after the shot.
39 2021-01-21 rash Immediately after receiving dose #2 developed a warm sensation from her arm that traveled to her che... Read more
Immediately after receiving dose #2 developed a warm sensation from her arm that traveled to her chest. HR 140bpm after receiving vaccine, BP also reported elevated but value not available. Also developed rash over chest. Was sent to ER for observation, given Benadryl, then discharged with epi pen.
39 2021-01-21 injection site tingling Patient began to complain of shortness of breath, tingling in left arm (in which she received the va... Read more
Patient began to complain of shortness of breath, tingling in left arm (in which she received the vaccine), dizziness, and "seeing spots" approximately 5 minutes after administration of COVID-19 vaccine. Patient was found to have low blood pressure of 86/58. A code blue was called by COVID clinic staff. Upon rechecking vitals, the patient's blood pressure had improved to 136/79 and her oxygen saturation on room air was 100%. The patient was advised to go to the emergency department for continued monitoring but refused.
39 2021-01-21 skin spots Petechial rash
39 2021-01-21 hives hives, swelling of upper lip, localized to one area. No SOB, no throat swelling. Observed for addi... Read more
hives, swelling of upper lip, localized to one area. No SOB, no throat swelling. Observed for additional 20 minutes and 1 dose (12.5 mg) of Benadryl given. Some improvement noted. Patient advised to call 911 if symptoms worsen. Will need 30 minutes of observation for second dose.
39 2021-01-22 skin swelling Significant eye pain, swelling, puffiness, blurry vision, and headache, disorientation. started 3 ho... Read more
Significant eye pain, swelling, puffiness, blurry vision, and headache, disorientation. started 3 hours after receiving second dose of covid/pfizer vaccine and continues 2 days later. Has NOT resolved
39 2021-01-22 injection site pain Sore arm at injection site a few hours after injection.-took ibuprofen. Around 12am was woken up wit... Read more
Sore arm at injection site a few hours after injection.-took ibuprofen. Around 12am was woken up with chills. Took my temperature and it was low grade (99.6)- took ibuprofen . Woke up at 6am with body aches, nausea and dizziness. Took temperature and it was 100.6-took ibuprofen. Symptoms cleared up around 3pm 1/22
39 2021-01-22 injection site pain The day of the shot about an hour and half I started feeling achy pain in my knee to my toes and my ... Read more
The day of the shot about an hour and half I started feeling achy pain in my knee to my toes and my leg went numb. I had a headache and felt confused, I couldn't remember what to do. The site was sore, I was dizzy, nausea and tired. This lasted for about 2-3 days .I took the next day off. The Dr. at my work said it should go away.
39 2021-01-23 injection site warmth, redness, injection site redness, hives Red, warm to the touch, welt surrounding injection site began to spread down left arm. Right side of... Read more
Red, warm to the touch, welt surrounding injection site began to spread down left arm. Right side of face became red, warm. Mildly feverish, mildly achy, mild nausea. After approximately 2 hours, symptoms resolved without medication. Redness around injection site resumed previous size.
39 2021-01-23 itchy skin, rash Scattered rash first noted on ankle area, right shin, right shoulder, neck, slightly around nose. G... Read more
Scattered rash first noted on ankle area, right shin, right shoulder, neck, slightly around nose. Generalized itching throughout the body.
39 2021-01-24 redness 1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdo... Read more
1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdominal cramping for the rest of the day. I took some ibuprofen. The following morning (Wednesday), the pain was on my right abdomen and right flank area only. It was persistent, achy, soreness. My insides felt very tender to put any pressure on my right abdomen or flank. The pain on the right side of my back became more intense as the day went on. I had sharp right flank pain when lifting my right leg after showering to get dressing and use lotion. When I was walking up the stairs I turned to the left and had a sharp pain in the right flank again, taking my breath away for a moment. Around 4pm I took ibuprofen. About an hour later my eyes felt hot and tired. My cheeks were pink. My temp was 99.2. I generally just didn't feel good from this achiness. I took Benadryl and went to bed at 7pm, and slept for about 12 hours, waking once at midnight. The following day (Thursday) I felt 99% better and contacted my doctors office. When putting pressure on the same areas I could feel very slight tenderness if I pushed hard. That evening and into the next morning (Friday) I was mildly achy on my right side but barely at all. I didn't feel any more discomfort until this past week on the 22nd or 23rd. During sexual intercourse I felt that same mild internal tenderness on my right side. At this time, I don't believe I have any pain. My urine seems unusually clear, light colored, and smaller volume but this is very subjective. I have some abdominal swelling but this has been present since my breast reconstruction in January of 2020 and seems to get worse or better depending on the days activities or meals so it's hard to know what causes what. Labs were done on 1/22 showing decreased kidney fuction. Pending tests include an ultrasound of the Right Ovary that remains after the hysterectomy, bladder, and kidney. In addition to a 24 hour urine and some other urine studies.
39 2021-01-24 hives, itchy skin, rash Approximately 7 days after vaccine individual developed skin eruptions that resembled drug-induce ur... Read more
Approximately 7 days after vaccine individual developed skin eruptions that resembled drug-induce urticaria and/or wheals on the hands, arms, legs, and in the buccal area, which was associated with significant itching, and prompted medical attention (PCP) to be seen. Prior to development of skin reaction, individual reported headache, nausea and dizziness.
39 2021-01-24 cellulitis CELLULITIS TO ARM ,TREATED WITH KEFLEX
39 2021-01-24 injection site swelling, injection site warmth Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fat... Read more
Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fatigue, achy, and nausea. Wake up at 11pm with fever 104.8, ears pounding, dizziness, swollen elbow and hand pain on same arm of injection. Fever over the next 24hrs went to 105.9. Nausea and extreme jaw pain and joint pain. fever resolved after 26hrs. Still having dizziness, arm around injection site is warm to touch, swollen, and joint painful. headache and neck pain still. treating with motrin and tylenol that was started 26hrs after the injection.
39 2021-01-25 rash, hives Dec 19 - One swollen lymph node to left neck Dec 25 - generalized rash/hives Dec 26 - urgent care... Read more
Dec 19 - One swollen lymph node to left neck Dec 25 - generalized rash/hives Dec 26 - urgent care for increased generalized rash/hives Jan 8 - received 2nd dose Jan 22 - 2 additional lymph node swollen left supraclavicular
39 2021-01-25 itchy skin FACIAL AND LEFT ARM ITCHING; LUMP IN THROAT. TREATED WITH BENADRYL, 50 MG PO AND SOLUMEDROL, 125 MG ... Read more
FACIAL AND LEFT ARM ITCHING; LUMP IN THROAT. TREATED WITH BENADRYL, 50 MG PO AND SOLUMEDROL, 125 MG IM.
39 2021-01-25 itchy skin FACIAL AND LEFT ARM ITCHING; LUMP IN THROAT; TREATED WITH BENADRYL AND SOLUMEDROL INJECTION
39 2021-01-25 itchy skin First vaccine on 12/30/20 almost immediately after receiving vaccine metallic taste in mouth, follow... Read more
First vaccine on 12/30/20 almost immediately after receiving vaccine metallic taste in mouth, followed by itchy throat and felt throat slightly thighten took Benadryl and received relief Second dose on 1/20/21 took a Zyrtec per doctor?s instruction prior to receiving vaccine about 15 minutes after receiving second dose tongue numbness and weird taste in mouth now and developed itchy face, managed with Zyrtec although itchiness not resolved, taking Zyrtec every day since second dose, yesterday 1/25 in afternoon still medicated under Zyrtec face began to swell on left side of face, persistent itchy face, itchiness went down to other areas including neck, chest, bumps on left hand now on an oral steroid per my doctor
39 2021-01-25 injection site rash, injection site warmth, injection site swelling General fatigue day of injection which resolved by morning. On day 6 after vaccination I developed a... Read more
General fatigue day of injection which resolved by morning. On day 6 after vaccination I developed a large well demarcated rash with warmth and swelling around the injection site. This has now mostly resolved this morning.
39 2021-01-25 injection site pain Injection site very sore, muscle very sore for 6 hours; injection site and muscle mildly sore for 6 ... Read more
Injection site very sore, muscle very sore for 6 hours; injection site and muscle mildly sore for 6 hours.
39 2021-01-25 rash with redness, itchy rash, hives One hive on my L side of my neck. Itchy, red, hot for at least 30 minutes. RN gave me Allegra after ... Read more
One hive on my L side of my neck. Itchy, red, hot for at least 30 minutes. RN gave me Allegra after 30 minutes of no new hives and no other symptoms.
39 2021-01-25 injection site pain SYMPTOMS LASTING 2 DAYS: MILD SKIN & MUSCLE SORENESS @ INJECTION SITE.. SEVERE CHILLS AND BODY ACHES... Read more
SYMPTOMS LASTING 2 DAYS: MILD SKIN & MUSCLE SORENESS @ INJECTION SITE.. SEVERE CHILLS AND BODY ACHES. FEVER FLUCTUATING BETWEEN 99.4 AND 101.2. TOOK IBUPROFEN EVERY 4 HRS AS NEEDED TO REDUCE FEVER.
39 2021-01-25 rash with redness chills; muscle ache; low grade fever up to 100.3; a red flushed rash on neck and chest; This is a sp... Read more
chills; muscle ache; low grade fever up to 100.3; a red flushed rash on neck and chest; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 09Jan2021 12:00 at single dose in left arm for covid-19 immunization. The patient had no other medical history and no known allergies. Concomitant medication included vitamin D3 and daily multivitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 20Dec2020 07:30 in left arm for covid-19 immunization. The patient had no covid prior vaccination and no covid tested post vaccination. The patient reported that on 10Jan2021 02:00 about 14 hours after 2nd vaccine she had chills, muscle aches, and low grade fever up to 100.3 for the next 12 hours. Then she experienced a red flushed rash on neck and chest for about 12 hours after the previous symptoms. All symptoms gone after about 24 hours. The patient did not receive any treatments for events. The outcome of the events was recovered on 11Jan2021.
39 2021-01-26 injection site pruritus, itchy skin An hour and a half after the injection I started feeling itchy at the site of injection and all over... Read more
An hour and a half after the injection I started feeling itchy at the site of injection and all over upper body/neck. I also started wheezing, had difficulty (not exptreme) breathing and was coughing . I called a medical professional that I know who has assisted at COVID19 vaccine sites about next steps and was advised to take a benadryl, so I did. About 45 minutes later felt fully recovered.
39 2021-01-26 skin warm, injection site swelling, injection site pain, redness Fatigue with insomnia. Skin turned red all over, not itchy, warm to touch. Swelling all over. Benadr... Read more
Fatigue with insomnia. Skin turned red all over, not itchy, warm to touch. Swelling all over. Benadryl seemed to help. Palm of left hand, pain in muscle near thumb. Joint pain in wrist and fingers, not unbearable but consistently noticeable so far. Pain at injection sight, swelling.
39 2021-01-26 injection site pain I woke up around 2am with chills, an intense headache and body aches. I have pain at my injection si... Read more
I woke up around 2am with chills, an intense headache and body aches. I have pain at my injection site.
39 2021-01-26 hives, itchy skin Patient rec'd Pfizer #1 on 1/22/21 (L deltoid) @ 3:30 p.m. 1/22 @ 4 p.m. - Hives & itching started ... Read more
Patient rec'd Pfizer #1 on 1/22/21 (L deltoid) @ 3:30 p.m. 1/22 @ 4 p.m. - Hives & itching started after obs, "feeling unwell" so patient returned to obs for additional 15 min. Cleared to RTW. After eating, @6 p.m. patient noted difficulty swallowing in evening & change in voice so she thought she had throat swelling. Took Benadryl 25 mg PO and Tylenol rapid release for HA. Hives resolved that evening and patient went to sleep. Over the weekend, had flu like symptoms, nausea, fatigue, HA. Took Benadryl 12.5 mg PO on 1/23 and continued Tylenol through weekend. 1/26 - 1/27: Signs and symptoms resolved
39 2021-01-26 itchy skin approx. 1.5 hours after the vaccine, i started having slight difficulty breathing, wheezing, coughin... Read more
approx. 1.5 hours after the vaccine, i started having slight difficulty breathing, wheezing, coughing and itchiness all over the upper body. I took a benadryl and the symptoms subsided about 45 minutes after taking the benadryl.
39 2021-01-26 injection site pain, bruising diarrhea at 3pm same day of vaccine till Saturday night. Friday night Pain to arm/injection site ar... Read more
diarrhea at 3pm same day of vaccine till Saturday night. Friday night Pain to arm/injection site around 10pm. Took Tylenol. Had slight pain to forehead around 8pm started to bruise. Saturday woke up with slight pain to arm/left side of neck. Bruise larger today. Saturday evening swollen. Lots of pain and trouble turn head. Left side neck/shoulder area pain. Applied ice/took Advil. At times hard to move arm, neck. bone pain by injection site. Now had pain from elbow to neck area, and shoulder on left arm for about 5 days now. At times pain feels like my bones hurt in those areas. Still swollen with bruising. Using pain meds ever 4 hours. And placing hot/cold packs with little relief.
39 2021-01-27 redness, itchy skin 39 yo female was noted ~40 minutes after vaccine to appear flushed. Her face, neck and upper arms we... Read more
39 yo female was noted ~40 minutes after vaccine to appear flushed. Her face, neck and upper arms were red. Upon questioning she reported she felt hot and itchy. Upon request she removed her jacket. Vital signs normal. She self-administered 25 mg of Benadryl. About 10 minutes later she reported developing a headache but otherwise reported some improvement in feeling hot and her facial/arm redness improved. She was originally given discharge instructions including home precautions and released to self, however a few minutes after leaving the patient walked back into the vaccination site and reported itching in throat with clearing throat. Patient was administered epinephrine 0.3mg IM and transferred to ER via EMS.
39 2021-01-27 hives, redness After the first COVID19 shot I got very red and very hot. I had a blinding headache for days. I re... Read more
After the first COVID19 shot I got very red and very hot. I had a blinding headache for days. I received the shot on a Wednesday afternoon and by Saturday I felt like I could claw my eye out, that I had something in it. I went to the eye doctor Monday morning and was diagnosed with a corneal ulcer. After the second COVID19 shot I was watched for 30 minutes based on my first reaction. I again turned very red and very hot. I had hives on my arms, neck, and behind my ears. I felt lightheaded and dizzy. I received 25 mg Benadryl by mouth and was observed for another 45 minutes. At that time I walked outside and felt worse. My throat became very itchy and I kept coughing. I went back in to tell provider and received an epi pen injection into my right leg, they took my vitals, and sent me to the hospital by ambulance.
39 2021-01-27 vaccination site redness, vaccination site swelling swelling on injection site for the first pfizer covid vaccine, it was red; swelling on injection sit... Read more
swelling on injection site for the first pfizer covid vaccine, it was red; swelling on injection site for the first pfizer covid vaccine, it was red; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received 1st dose of BNT162B2 (lot# EH9899), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications was not reported. On an unspecified date, she did experience swelling on injection site for the first pfizer covid vaccine, it was red. They had her draw a circle around it and monitor that it did not expand out of the circle. It did not and went down on its own. The outcome of events was recovered.
39 2021-01-28 injection site redness, injection site pruritus 1/8/21 (evening): Feeling weakness and tiredness 1/9/21: Itching and redness around the injection si... Read more
1/8/21 (evening): Feeling weakness and tiredness 1/9/21: Itching and redness around the injection site, all joints aching badly (8/10 pain scale) 1/10/21: White ring around injection site; Itching continued 1/11/21: White ring around injection site; Itching continued *Itching continued through 1/15/21. * White ring around injection site currently still visible on 1/29/21. No treaments given; advise by clinic to report via V-Safe.
39 2021-01-28 injection site mass, injection site pruritus, injection site rash 10 hrs after I received 1st dose of Pfizer I started feeling my heart beating rapidly and hard. I w... Read more
10 hrs after I received 1st dose of Pfizer I started feeling my heart beating rapidly and hard. I was short of breath and had nausea and a headache. This lasted for 1.5 hrs. then I laid down. As I was falling asleep I couldn't shake a scary "vision: I was having of myself like my eyes turning bright blue and electricity going through my body and my body ascending into the air. I had nightmares all night. I have never had hallucinations or whatever that was. And nightmares are rare for me. I woke up fine on day 2, just a stiff sore arm. Day 3 I was fine. Day 4 I am developing an itchy, bumpy, rash on my right arm at site of injection and around it. I reported this online on my health chart and will go in if I keep getting strange reactions.
39 2021-01-28 rash Body/ trunk and neck rash, no itching, burning, puss, etc. Completely asymptomatic. Hydrocortisone ... Read more
Body/ trunk and neck rash, no itching, burning, puss, etc. Completely asymptomatic. Hydrocortisone cream, Benadryl ineffective. Spoke with physicians assistant, she was unsure and referred me to an allergist currently waiting on call back for blood test appointment. Rash still present after 13 days.
39 2021-01-28 injection site pain Injection site pain- first dose and second dose Second dose only: Significant body aches for 24 hou... Read more
Injection site pain- first dose and second dose Second dose only: Significant body aches for 24 hours (started at 3:30 am after 1:30 pm vaccine given) Low grade fever Reduced appetite Nausea (started at 5 am on 1/29/2021)
39 2021-01-28 vaccination site pain Tiredness; painful swollen lymph nodes/lymph nodes on base of her neck started to become swollen and... Read more
Tiredness; painful swollen lymph nodes/lymph nodes on base of her neck started to become swollen and tender; injection site soreness; painful swollen lymph nodes/Lymph nodes on base of my neck started to become swollen and tender; kind of a side effect it was worst; my right deltoid is really very sore and my neck has really become sore.; my right deltoid is really very sore and my neck has really become sore.; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Brand=Pfizer; lot number: EL3248) via an unspecified route of administration at right arm on 13Jan2021 at 09:15 AM at a single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. No other vaccine in four weeks. Other medications in two weeks included hydrochlorothiazide/losartan potassium (LOSARTAN/HYDROCHLOROTHIAZIDE), pantoprazole sodium sesquihydrate (PROTONIX), multivitamins/plain (reported as MVI), biotin, docusate sodium (COLACE), Adde (to be clarified). The patient was not pregnant. Facility type vaccine was at Hospital. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced adverse events included tiredness, painful swollen lymph nodes, injection site soreness; all with start date on 13Jan2021 and with outcome of not resolved. No treatment received for events. It was also reported right deltoid had been sore, lymph nodes on base of her neck started to become swollen and tender; kind of a side effect it was worst, and neck had really become sore; all on 13Jan2021 and with outcome of unknown. The patient stated she had the vaccine on 13th and her right deltoid had been sore. Yesterday (15Jan2021) her lymph nodes on base of my neck started to become swollen and tender, she knew it's a kind of a side effect but it was worst today than it was yesterday and she just wanted to know how long those side effect last because her right deltoid was really very sore and her neck had really become sore.
39 2021-01-28 vaccination site pain fatigue; Pain at injection site; chills; body aches; headache; neck pain; joint pain; nausea; This i... Read more
fatigue; Pain at injection site; chills; body aches; headache; neck pain; joint pain; nausea; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 13Jan2021 09:45 at single dose in left arm for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient had no covid prior vaccination and no covid tested post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), via an unspecified route of administration on 23Dec2020 14:45 at single dose in left arm for COVID-19 immunization. The patient experienced pain at injection site, chills, body aches, headache, neck pain, joint pain, nausea, fatigue on 14Jan2021 02:00. The outcome of the events was recovered in Jan2021. The patient did not receive treatment for the events. No follow-up attempts are possible. No further information is expected.
39 2021-01-28 injection site swelling the right side swelling, swelling underneath armpit, swelling of collarbone and neck; This is a spon... Read more
the right side swelling, swelling underneath armpit, swelling of collarbone and neck; This is a spontaneous report from a contactable Nurse reporting for herself. A 39-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL0142) vaccine, intramuscular on 12Jan2021 15:30 at single dose for Covid-19 immunisation. Medical history included deep vein thrombosis, provoked DVT, and moderate asthma . There were no concomitant medications. The patient received the first dose of BNT162B2 vaccine on 23Dec2020. The patient experienced right side swelling on 12Jan2021 some hours after injection. On 13Jan2021 swelling underneath armpit was significant, swelling of collarbone and neck was also present. The reported event was considered Important Medical event. The outcome of the event was recovering. The event was treated with Round the clock Ice pack. Antihistamine and NSAIDs. Followup information has been requested. Lot number already provided.; Sender's Comments: Based on the compatible temporal association, a contributory role of suspect vaccine BNT162B2 in the development of "the right side swelling, swelling underneath armpit, swelling of collarbone and neck" cannot be excluded. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-29 pain of skin At 6 hours after shot, I developed fever to 101, sever chills, body aches, joint pain, my skin hurt... Read more
At 6 hours after shot, I developed fever to 101, sever chills, body aches, joint pain, my skin hurt, headache and extreme fatigue. This lasted for 24 hours resulting in loss of work the next day. Then 6 days later, I am still tired and achy, have soreness in my upper arms, and have a severe headache.
39 2021-01-29 hives, redness Extreme urticaria (itchiness). Mild hives on arm and redness on neck and arm. Numb lips. Took 50 mg... Read more
Extreme urticaria (itchiness). Mild hives on arm and redness on neck and arm. Numb lips. Took 50 mg diphenhydramine mild relief slept overnight normal in am, arm only sore
39 2021-01-29 itchy skin hoarseness, cough, pruritus, treated with IV solumedrol and diphenhydramine
39 2021-01-30 injection site pain Body aches started around 11pm day of the shot. I was up off and on all night due to them. These la... Read more
Body aches started around 11pm day of the shot. I was up off and on all night due to them. These lasted through the following day but decreased a bit over time. Sore arm at injection site started the next (saturday) morning. It is still sore today (sunday) but isn't as bad. Low grade fever on Saturday around lunch time. Took tylenol a couple of times during the day and fever is gone today (sunday)
39 2021-01-31 injection site mass, injection site rash Injection site developed a large lump and a 2 inch diameter rash that continued after 2 days post va... Read more
Injection site developed a large lump and a 2 inch diameter rash that continued after 2 days post vaccination. It has not resolved yet.
39 2021-01-31 itchy skin Severe swelling, itching and pain in right side of mouth, chin and cheek. Swelling inside the mouth... Read more
Severe swelling, itching and pain in right side of mouth, chin and cheek. Swelling inside the mouth, itching, slight swollen tip of the tongue on the right side
39 2021-01-31 injection site numbness, injection site reaction Two minutes post injection her arm went numb at site & then shot down to finger tips. At times ther... Read more
Two minutes post injection her arm went numb at site & then shot down to finger tips. At times there is throbbing (like punch) just at the site. Feels like her arm went to sleep.
39 2021-02-01 rash papular, rash, cellulitis, itchy skin Mild pimple looking rash started on 1/5/21. Felt better after few days. Rash/ papules looks like pim... Read more
Mild pimple looking rash started on 1/5/21. Felt better after few days. Rash/ papules looks like pimple started spreading rapidly all over the body with itching on 1/14. Benadryl PO x 1 dose. Valacyclovir and Zyrtec started on 1/16. Prednisone started on 1/21. Cellulitis 1/22. Keflex PO. Started tapering down prednisone but rash started coming back 1/29.
39 2021-02-01 itchy skin, hives Patient reported itching, hives on neck and arms and headache within 20-25 minutes of receiving her ... Read more
Patient reported itching, hives on neck and arms and headache within 20-25 minutes of receiving her vaccine. Patient was evaluated in the EC and treated with Benadryl, Pepcid, Prednisone and Tylenol. Patient was discharged from EC at 4:45pm.
39 2021-02-01 rash Started with a rash to my neck and chest. A day or a rash started to develop on my forehead, eye lid... Read more
Started with a rash to my neck and chest. A day or a rash started to develop on my forehead, eye lids and under one eye. Lymph node in my neck was also swollen. A week later my lips are slightly swollen, rash is better on my neck but is worse on my face.
39 2021-02-02 itchy skin, hives, redness I received COVID vaccine #1 on 6 Jan 21. Shortly following the vaccine I turned very red and felt v... Read more
I received COVID vaccine #1 on 6 Jan 21. Shortly following the vaccine I turned very red and felt very hot. The next few days I experienced a very bad headache and flu like symptoms. On 9 Jan 21 my left eye felt very irritated and had redness. I was seen by optometry on 11 Jan 21 and was diagnosed with a corneal ulcer. I received COVID vaccine #2 on 27 Jan 21. I was observed for 30 minutes based on the first vaccine experience. I got very flushed, red, and hot and very itchy. I felt lightheaded and not right. I had hives behind my ears and on my chest. I notified one of the vaccine staff who gave me 25mg Benadryl by mouth and took my vitals. The staff observed me for another 45 minutes. Once I went outside the back of my throat felt very itchy. I felt like I had something in my throat and I had to keep trying to clear my throat. I got very red, hot, and itchy again. I went back inside to tell the staff. They gave me an epi pen injection into my right thigh and called the ambulance. I was taken to the ER to be evaluated. Two days later I noticed the back of my throat was very red and my uvula was large and elongated. I called the clinic and was given cough drops and Cepacol. I have been experiencing hives, redness, and feeling very itchy. To a point I have been having to take Benadryl. I took the 5 days of steroids and ended them on Monday. Yesterday, 2 Feb 21 I woke up and my right eye was bloodshot, irritated, and uncomfortable. I was seen at Urgent Care and prescribed Ofloxacin 4x a day for 10 days. They did not notice any scratches or anything. My right eye is still uncomfortable and red. I am currently on day two of the eye drops.
39 2021-02-02 injection site pain Injection site pain, starting approximately 2 hours after receiving shot and continuing for the next... Read more
Injection site pain, starting approximately 2 hours after receiving shot and continuing for the next 24 hours. Headache starting around 10am the day after receiving the vaccination, continuing for approximately the next 12 hours. Chills and body aches starting around 10am the day after receiving the vaccination, worsening over the next 3 hours, continuing for approximately an additional 10 hours. No pharmaceutical treatment taken. All adverse events were resolved upon waking the following day (approximately 40 hours after vaccine administration).
39 2021-02-02 redness Patient voiced having metallic taste in mouth and had mild redness on chest and stated chest felt wa... Read more
Patient voiced having metallic taste in mouth and had mild redness on chest and stated chest felt warm. Patient denied any itching.
39 2021-02-02 itchy skin approximately 10 min after receiving the vaccine I became very itchy. I notified the nurse and was g... Read more
approximately 10 min after receiving the vaccine I became very itchy. I notified the nurse and was given 50 mg of oral benydrl and then taken to the Emergency department. In the ED I was given Epinephrine, Medrol prednisone IV , benydrl, famotidine, and nebulizer treatments. I was also placed on )2 due to falling saturation levels.
39 2021-02-03 rash -Palpitations -Rash -Tingling of Hands and Feet
39 2021-02-03 itchy skin @ approximately 0850 itching which lead to anaphylactic reaction was sent to the ED O2 Saturation 71... Read more
@ approximately 0850 itching which lead to anaphylactic reaction was sent to the ED O2 Saturation 71%, SOB, nausea, emesis x1, fatigue, coughing. CG given Epi, Benadryl, Steroids, Neb tx. D/c'd to home w/ Epi pen, steroids, and Benadryl. Advised possible reoccurrence anaphylactic symptoms. Advised to f/u w/PCP.
39 2021-02-03 rash, redness Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following ... Read more
Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: flush feeling. She was already in her car. She looked in the mirror and noted redness on her neck. She then came back to the clinic. redness on her neck and chest Lot: EL3247 Time of Administration: 01/29/2021 1106am Time Symptoms Began: 15-20+ minutes _____ When arriving back in the clinic, she was taken to the medical observation area. Initial Assessment @ _1141am_: Patient is AAO. The employee sat on the sofa. The employee is pink and does not appear to be in distress. They are talking and making conversation. She has some redness on her neck. Vitals @:1142 HR: 107 BP: O2: 98 Given a water to drink. NO itching, tingling, scratchy feeling. Vitals @: 1145 HR: 94 BP: O2:99 Allergies: Percocet. Started as a rash on her chest. Then she had facial swelling. Was treated with prednisone. No anaphylaxis ever. Employee was discharged without treatment. Advised to take a benadryl when she gets home. She lives about 15 minutes from the clinic.
39 2021-02-03 rash Pfizer-BioNTech COVID-19 Vaccine EUA---At Approximately 1030 PM on 2/2/21 I began having muscle ache... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA---At Approximately 1030 PM on 2/2/21 I began having muscle aches. 2/3/21 @ 0800Am temp was 100.7. Throughout the day 2/3/21 I had a temp of >99.7 but <101, muscle aches (1day) HA(1day) and a rash on the trunk area. The fever stopped at approximately 1100PM 2/3/21.
39 2021-02-03 injection site pain Sustained tachycardia from 0900 until 1800 on Feb 2nd while laying in bed or on the couch. Ranged fr... Read more
Sustained tachycardia from 0900 until 1800 on Feb 2nd while laying in bed or on the couch. Ranged from 97-109. The average was 103. Tightness in chest, sweating, generally feeling unwell. Additionally, standard symptoms were present. Pain at injection site, pain under the left arm (lymph nodes), body aches, headache, fatigue. No fever and no shortness of breath.
39 2021-02-04 redness I woke up the following morning feeling extremely drowsy. Swelling of lymph node under my arm and fi... Read more
I woke up the following morning feeling extremely drowsy. Swelling of lymph node under my arm and fingers and every so often my arm will swell showing my veins. Redness. extreme cramping. Cramping on the 2nd and 3rd day in the lower extremities. 2nd, 3rd and 4th day had headache. I still still get the drowsiness every once in a while as well as other symptoms.
39 2021-02-04 injection site swelling, injection site redness, injection site pruritus The site where I got the shot was red, swollen, and itchy when I woke up this morning. It feels much... Read more
The site where I got the shot was red, swollen, and itchy when I woke up this morning. It feels much better now, but I wanted to report it.
39 2021-02-05 itchy skin Facial swelling, neck swelling, dizziness, shortness of breath, nausea, warm feeling, lips itchy, fa... Read more
Facial swelling, neck swelling, dizziness, shortness of breath, nausea, warm feeling, lips itchy, face itchy
39 2021-02-05 injection site pruritus, injection site hardening, injection site swelling, injection site redness, injection site warmth Itching at injection site, hard, hot to touch, red the size of a dollar coin. No treatment.
39 2021-02-05 rash, bruising, rash macular, hives Rash/welt on shot arm developed 2 days later underneath arm not at injection site. Red blotchy not i... Read more
Rash/welt on shot arm developed 2 days later underneath arm not at injection site. Red blotchy not itchy but very tender and bruised feeling.
39 2021-02-05 skin warm Reported signs and symptoms of aches and chills same as after first does. Significant nausea and dia... Read more
Reported signs and symptoms of aches and chills same as after first does. Significant nausea and diarrhea, arm pain and warmth, unable to turn neck without pain, temperature 100.5.
39 2021-02-06 rash, hives About an hour after receiving the vaccine I had a rash (hives?) on my left shoulder and chest. I too... Read more
About an hour after receiving the vaccine I had a rash (hives?) on my left shoulder and chest. I took a Benadryl and some Ibuprofen and it went way after a couple of hours.
39 2021-02-07 hives Hives
39 2021-02-07 rash Rash on both forearms and back. Flat red spots about the size of pencil erasers. Not itchy.
39 2021-02-07 cellulitis, injection site swelling, injection site warmth cellulitis in arm; Dizzy head; sore; a few lymph nodes reacted; This is a spontaneous report from a ... Read more
cellulitis in arm; Dizzy head; sore; a few lymph nodes reacted; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient was pregnant. The patient received the first dose of BNT162B2 (lot number: EL0140) on 28Dec2020 for covid-19 immunization. On an unknown date in Jan2021, the patient experienced Dizzy head and sore. Then injection site swelling and was hot to the touch and a few lymph nodes reacted. Two days of 102+ fever, diagnosis of cellulitis in arm. Antibiotics received for cellulitis. Adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Information on the lot/batch number has been requested.
39 2021-02-07 vaccination site pain injection site (arm) soreness; This is a spontaneous report from a contactable consumer. This consum... Read more
injection site (arm) soreness; This is a spontaneous report from a contactable consumer. This consumer reported a 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on arm single dose for COVID-19 immunization on 20Jan2021 at 39-year-old. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had injection site (arm) soreness on 20Jan2021 and was reported as non-serious. No treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving. Information on the lot/batch number has been requested.
39 2021-02-08 skin warm, hardening, redness 20 hours after shot, persistent fever maintained at 102.7 while covered by Tylenol 1 gram and Motrin... Read more
20 hours after shot, persistent fever maintained at 102.7 while covered by Tylenol 1 gram and Motrin 800 mg being taken every 6 hours. Severe chills, shaking, body soreness, and fatigue. Left Arm swelling, redness the size of a softball, hard and hot skin. Arm swelling lasted for 6 days.
39 2021-02-08 itchy skin, vaccination site warmth, vaccination site swelling 8 days after vaccine I had a red raised spot on my arm at the site of the vaccine. It was itchy and... Read more
8 days after vaccine I had a red raised spot on my arm at the site of the vaccine. It was itchy and warm to the touch. It was not painful and I did not have to take any medication. It went away around 24 hours after I noticed it.
39 2021-02-08 injection site pain Around 6am on Sunday, the day after I received the vaccine, I woke up with the following symptoms: ... Read more
Around 6am on Sunday, the day after I received the vaccine, I woke up with the following symptoms: injection site pain, fatigue, headache, chills, fever, nausea, swelling in my under arm and loss of taste. I was out for the entire day. On Monday, I woke up with the same symptoms but they were milder than the day before. I called to schedule an appointment with my doctor today, Tuesday, to go over my reaction to the vaccine. I still have swelling under my arm and loss of taste and fatigue.
39 2021-02-08 bruising Pfizer-BioNTech Covid -19 Vaccine EUA 2/6/21 mild headache, body aches around 1800 hours. Insomnia,... Read more
Pfizer-BioNTech Covid -19 Vaccine EUA 2/6/21 mild headache, body aches around 1800 hours. Insomnia, vivid dreams, body aches and feeling cold around 2300 hours. 2/7/21 fatigued, body aches 2/8/21 severe fatigued, stronger headaches, body aches, swollen lymph nodes - contacted primary care (waiting for nurse to return my call. I was able to get an appointment online for March) 2/9/21 mild headaches, a large purple bruise on left inner thigh. Lymph nodes are still painful. (I called my primary care and I?m waiting again for the call back)
39 2021-02-08 injection site rash, injection site pain, rash Site: Pain at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild, Systemic: Chills... Read more
Site: Pain at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild, Systemic: Chills-Medium, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Other- slight pain in left thoracic area followed by chills and fluctuation in blood pressure and pulse-Medium; lasted 1 day.
39 2021-02-09 redness, skin warm, rash Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the... Read more
Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the body aches were progressively worse and concentrated on left side of body. Joints were affected including left wlbow, wrist, shoulder. Hot viral rash appeared on arm right above left elbow that became painful with swelling and erythema. In Sunday through the following Wednesday, joint pain continued to worsen and settle in additional joints including first 2 metacarpal bones of both hands almost like arthritic pain. Fingers and joints red and swollen. Pain and swelling next settled in toes of both feet, right side elbow, shoulder and knee. On Monday following vaccine I called employee health and they advised me to come and take covid test. I described symptoms and was told they were side effects of the vaccine and to follow up with a doctor if it continues. My covid test was negative. On the following Thursday I went to urgent care and described my persisting symptoms. I was prescribed a methylprednisolone pack and hydroxyzine. I was told to use naproxen as needed. Yesterday the urgent care sent a check up message. I am still experiencing joint pain although the intensity has decreased but it is still significant pain that is disabling my grip and strengrh overall. The joint pain is mostly just in my upper extremities, hands, fingers and shoulders now consistently. The np prescribed a 10 day pack of meloxicam to try and help minimize the pain.
39 2021-02-09 redness Migraine headache within 3 hours of vaccine. This was the exact same headache I had described a coup... Read more
Migraine headache within 3 hours of vaccine. This was the exact same headache I had described a couple days after my first COVID-19 vaccine on 12/24/20. The pain started in the base of my skull, and radiated up around the outside and back of my head and in the front by my eyes. This lasted about 6 hours this time. I used iced, heat, and Excedrin Migraine. That did help this time. I also had hot flashes for about a week afterwards. My face, ears, chest and palms of my hands turned bright red off and on during the day. I took some Benadryl and that seemed to help.
39 2021-02-09 itchy rash Mild itchy rash on neck and chest; This is a spontaneous report from a contactable healthcare profes... Read more
Mild itchy rash on neck and chest; This is a spontaneous report from a contactable healthcare professional (patient). This 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration in the right arm on 21Jan2021 at 10:30 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have any allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine, omeprazole, and birth control. The patient did not have any other vaccines within 4 weeks prior to the vaccine. On 22Jan2021, the patient experienced a mild itchy rash on the neck and chest. The patient did not receive any treatment for the event. The outcome of the rash was recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
39 2021-02-09 vaccination site pain body aches; She feels like she has shortness of breath; feeling really tired/fatigued; chills and sw... Read more
body aches; She feels like she has shortness of breath; feeling really tired/fatigued; chills and sweats; chills and sweats; sore at injection site; lost sense of smell; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), intramuscular in left deltoid on 23Jan2021 15:35 at SINGLE DOSE for covid-19 immunisation. She typically got sick when she got the flu vaccine or any vaccine in general for immunization, she got deathly sick. She always got the flu after getting the flu vaccine. She did not get the flu shot this year and she did not get the flu. She did not know the name of the flu vaccine or any vaccine that she was referring to and she did not have lot number to provide. Other medical history was reported as none. There were no concomitant medications. Relevant Tests were reported as none. The patient experienced lost sense of smell on 23Jan2021 with outcome of not recovered, feeling really tired on 24Jan2021 with outcome of not recovered, chills and sweats on 24Jan2021 with outcome of recovered on 25Jan2021, sore at injection site on 24Jan2021 with outcome of not recovered, body aches and Shortness of breath on an unspecified date with outcome unknown. Details were as follows: the patient had a list of the expected side effects and she did not see loss of sense of smell on the list. Reported she completely lost her sense of smell, she cannot smell anything at all. She was asking if she should be concerned. On Friday prior to getting the vaccine she could smell everything. She thought the loss of smell started Sunday, reported it may have started Saturday (23Jan2021). She noticed when she put her body spray on Sunday and she was washing her hands that she could not smell. She can taste fine. She can handle the body aches and all the other stuff. She clarifies she was experiencing body aches, she was feeling really tired, fatigued. She was feeling better. She could not call earlier because she was so tired. She had the chills and sweats that started Sunday evening and recovered today (25Jan2021). Reported her sheets were drenched with sweat when she woke up. She did not have a fever. She thought most of her side effects started Sunday night. Reported the injection site was sore and that started the day after receiving her injection, it was still sore. She did not go to work today (25Jan2021). She felt like she had shortness of breath but she was checking her oxygen level and it was fine, stated it just felt like she was short of breath and it was ongoing and persisting. No additional vaccines Administered on Same Date. The events did not require a visit to Emergency Room and Physician Office.
39 2021-02-09 vaccination site pain muscle pain in her arm where she received the injection; cough; hoarseness in her voice; clearing of... Read more
muscle pain in her arm where she received the injection; cough; hoarseness in her voice; clearing of the throat; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. Medical history included has ongoing allergies and has to take an "allergy pill" every day for this condition, diabetes and hypothyroidism. Concomitant medication included levothyroxine, ertugliflozin pidolate (STEGLATRO), loratadine, montelukast, metformin, atorvastatin, lisinopril, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), dulaglutide (TRULICITY) and ongoing allergy pill. She reported that she received her vaccine in a mass Covid vaccination. The reporter stated that she developed muscle pain in her arm where she received the injection, which she states that she understands this is a commonly reported side effect. She also developed a cough, hoarseness in her voice, and noticed that the cough was worse when she went to bed. She mentioned that her cough started on Wednesday, she felt like it was little bit worse on last night (unspecified date), than it was on Saturday, so she means it was only Sunday after that [pending clarification]. The reporter was heard clearing her throat multiple times on the phone during the conversation. She would like to know if the cough, hoarseness and clearing of the throat are commonly reported symptoms. The patient was informed that the injection side pain was reported last on average between 1-3 days. Per the EUA Prescribing Information, "Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days" and that we did not have information on how long her mild respiratory symptoms may last and referred her to her HCP. The patient was encouraged to contact her healthcare professional if her symptoms did not go away or if they became worrisome and she verbalized understanding. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included blood work showed normal on 15Jan2021. The outcome of the event cough was not recovered while the outcome of the other events was unknown. Information about Batch/Lot number has been requested.
39 2021-02-09 rash red, raised, pimp rash to chest and back 2 days after injection continued up neck and face 1 week in... Read more
red, raised, pimp rash to chest and back 2 days after injection continued up neck and face 1 week into rash. 2 weeks into rash was suggested to use nizoral anti-dandruff shampoo and let set for 5 mins. 2-3 days later rash was resoved.
39 2021-02-10 injection site pain I had a migraine beginning Feb 9 AM. I have chronic migraines that almost always occur on the left s... Read more
I had a migraine beginning Feb 9 AM. I have chronic migraines that almost always occur on the left side of my head, but this one was on the right side, which is unusual for me. The migraine pain was more severe than normal. I also had a stiff right jaw and eye pain primarily on the right side. I took 100 mg Imitrex in the afternoon of Feb 9 and it reduced the pain very effectively (which is also unusual for me). On Feb 10 AM, the migraine returned or a new one started. The pain was also in the right side. I took 100 mg Imitrex and it reduced the pain somewhat effectively. The migraine pain returned Feb 11 AM and hurt on both sides of my head. I took 100 mg Imitrex this evening (Feb 11) and it is helping so far. In addition, my left arm was sore around the injection site beginning when I got the shot and stopped this morning.
39 2021-02-10 hives, rash Patient received her 1st dose of Pfizer vaccine around 1810 on 2/9. Approximately 10-15 mins later h... Read more
Patient received her 1st dose of Pfizer vaccine around 1810 on 2/9. Approximately 10-15 mins later her arm was shaking uncontrollably, she felt that her throat was closing and had chest pressure. Medics noted hives and a rash on her chest and administered Epi and Benadryl. She began exhibiting stroke-like symptoms of expressive aphasia and dysarthria in the medic?s truck around 1850. She was crying and unable to speak. She had right sided facial droop, right sided grip weakness, and right sided arm drift. Patient was transferred to MC. Patient Update: Patient received tPA on 2/9 at 1949. CT revealed no hemorrhage or large territory stroke and no large vessel occlusion. NIHSS on admission to MC was a 3. Patient was also assessed by speech pathology. Patient appears to have been discharged home on 2/10. Patient to follow up with Outpatient Neuro PT Rehab as she is having some issues with mobility, gait, and overall functional mobility. She is using a 2 wheeled walker at this time.
39 2021-02-11 vaccination site redness, vaccination site rash I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headach... Read more
I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headache; had nightmares all night; stiff, sore arm; stiff, sore arm; my arm has a bumpy, red mild rash at and around injection site; my arm has a bumpy, red mild rash at and around injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 39 years) as a single dose in the right arm for COVID-19 vaccination. Medical history included fatty liver. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications were not reported. The patient reported that on 27Jan2021 at 12:30 AM, approximately ten hours after the vaccine, the patient experienced a rapid and hard heartbeat, shortness of breath, nausea and headache. These lasted for one and one half hours. As she lay down falling asleep she got a strange vision/hallucination (this had never happened to her before) of her eyes turning lightning blue and her body rising up in the bed. She stated that she does not take medications or drugs and does not have a history of mental illness. She could not shake the vision. She fell asleep and had nightmares all night and nightmares are rare for her. One day two she woke up fine just a stiff, sore arm. On day three her arm has a bumpy, red mild rash at and around injection site. The patient did not receive any treatment for the events. Lab data included a COVID SARS CoV-2 positive test on an unspecified date. The clinical outcomes of hallucination, heart rate increased, shortness of breath, nausea, headache, nightmares, pain in arm, limb stiffness and vaccination site rash were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
39 2021-02-11 skin warm at 4am started with severe shaking chills, severe nausea that worsened until around 8am (temperature... Read more
at 4am started with severe shaking chills, severe nausea that worsened until around 8am (temperature was measured at 97.7 degrees F). at 8am had vomiting x 4 episodes over the next 20-30 minutes. chills and nausea continued. at 10:30am changed to feeling warm concern for fever - temperature measured at 100.2 degrees F, sweating, malaise and severe fatigue. Took 1gm oral acetaminophen at around 10:45/11am and fever-ish feelings resolved around 2pm.
39 2021-02-14 injection site redness, injection site pain, injection site swelling Lymphadenopathy to Right axilla, fever, body aches, chills, injection site erythema/pain/swelling
39 2021-02-14 redness Red face and chest pain started on 2/9/2021. Resolved by 2/10/2021.
39 2021-02-15 injection site pain, injection site swelling, injection site warmth Adverse effects: fatigue/dizziness/headache, resolved after 24 hours, left arm pain and swelling ar... Read more
Adverse effects: fatigue/dizziness/headache, resolved after 24 hours, left arm pain and swelling around injection site persist for 2-3 days, swelling is continue getting bigger, warm and tender to touch. Tx: possible post-vaccination cellulitis (left arm), given Keflex 500mg tid for 7 days, OTC NSAID prn for pain, swelling edge marked and advised monitor swelling edge, seek immediate care if getting worse, follow up with PCP.
39 2021-02-15 itchy skin Patient experienced facial itching approx 5 minutes after vaccination. Denies swelling in throat, mo... Read more
Patient experienced facial itching approx 5 minutes after vaccination. Denies swelling in throat, mouth. BP 141/90, Sp02: 98%. RRT called and patient refused ED transport. Sat for approx 30 minutes in obs area before leaving on her own. Airway assessed by RRT and no concern for respiratory compromise.
39 2021-02-16 itchy skin Anaphylaxis: After my second dose of the vaccine within 3-5 minutes I stared feeling swelling of th... Read more
Anaphylaxis: After my second dose of the vaccine within 3-5 minutes I stared feeling swelling of the thong, itchy throat, head, neck, sob. I immediately reported my symptoms to the MD that was in the room monitoring the recent vaccinated employees. Immediately he administered 50mg of Benadryl, 20mg of Pepcid, and salbutamol. I was rushed to the ED and stayed there for couple of hours headed back to my unit and then sent home by my manager.
39 2021-02-16 redness, itchy skin Pt stated that 5 minutes after receiving the vaccine her chest and neck became itchy. Pt presented w... Read more
Pt stated that 5 minutes after receiving the vaccine her chest and neck became itchy. Pt presented with redness and no hives. Pt denied any difficulty breathing or swallowing. Pt was given 50mg of Benadryl orally. Pt was monitor for an hour and a half. Pts vitals remained stable. Pt stated she is no longer feeling itchy. Pt no longer has any rash on her chest or around her throat. Pt refused transport to hospital.
39 2021-02-16 rash, shingles Shingles rash 5 days after 2nd shot. First two days after the shot I felt ill with general unwell, l... Read more
Shingles rash 5 days after 2nd shot. First two days after the shot I felt ill with general unwell, lymph nodes hurt, headache, tired. Day 4 noticed pain on stomach and back area and day 5 noticed rash. Day 6 rash was significantly worse and painful. Confirmed shingles on day 6 from doctor.
39 2021-02-18 injection site pain About ten minutes after administration, the patient developed transient left hand tingling, numbness... Read more
About ten minutes after administration, the patient developed transient left hand tingling, numbness, and weakness, as well as pain at the injection site. The patient was monitored for another 15 minutes, but it appears that her symptoms, other than the injection site pain, was abating. She denied systemic symptoms.
39 2021-02-18 itchy skin, hives Hives, severe itching, leg pain
39 2021-02-18 hives, itchy skin I had a reaction about 3 or 4 hrs later and was very itchy. I had hives on trunk and arms. I was itc... Read more
I had a reaction about 3 or 4 hrs later and was very itchy. I had hives on trunk and arms. I was itching in my throat and ears. I took a couple doses of Benadryl and Pepcid. I also felt like I was experiencing SOB. I went to the doctor the next day and was prescribed steroids. I continued taking everything for the next few days and was unable to work.
39 2021-02-18 injection site pain Injection site arm pain, headache, grabbing low back pain first on 2/11, resolved on 2/13. Then repe... Read more
Injection site arm pain, headache, grabbing low back pain first on 2/11, resolved on 2/13. Then repeated on 2/16 with injection site arm pain followed by back pain & headache. Arm pain gone on 2/18, but back pain and headache persisting.
39 2021-02-18 injection site pain Mild dull continuous headache(6:30am-at least 8:50pm while completing survey) Lethargic/tired (appro... Read more
Mild dull continuous headache(6:30am-at least 8:50pm while completing survey) Lethargic/tired (approximately 10 hours so far) Sore arm at injection site. Started about 15-30 minutes after injection.
39 2021-02-18 rash On the 3rd/4th day AFTER I was vaccinated with Pfiser, I became very swollen all over my body, but a... Read more
On the 3rd/4th day AFTER I was vaccinated with Pfiser, I became very swollen all over my body, but ankles and legs, arms and writst, face (not throat) were effected. I also had a rash on my arms and upper chest area. I was told to start taking 10 mg a day of prednisone and it has finally cleared up.
39 2021-02-18 injection site pain Sore arm at injection site, for 24 hours after administration
39 2021-02-18 rash, rash maculo-papular, skin spots The patient was admitted to the hospital on February 10, 2021 for evaluation of jaundice. This is a... Read more
The patient was admitted to the hospital on February 10, 2021 for evaluation of jaundice. This is a healthcare worker (direct patient care) and she received the first dose of Covid 19 vaccine in January 13 2021, then subsequently developed some abnormalities of the liver enzymes and thrombocytopenia. Because of this, her second vaccine was held. She also subsequently noticed scleral jaundice. She reports that it was 5 days since the COVID-19 vaccine on January 13 when she developed a rash which was present in the legs anterior abdomen and arms. Then 8 days after the vaccine, she developed a different rash on top of the original which was less petechial and more maculopapular. The rash is pruriginous, its been intermittently worsening and improving. She had no fever associated with the rash, although she reports that the day before admission February 9, she had some chills and sweats. She had some mild abdominal pain and cramps. No prior history of hepatitis. She also developed a petechial rash predominantly in the lower extremities. Results of ancillary studies showed that her AST is currently (02/12/21) 196 ALT of 61, her bilirubin total was 7.9 with a direct of 5.5, and on admission her AST was 183 ALT 40, with a total bilirubin of 14. Her platelet count on admission was 111, currently is 93. She has some mild microcytic anemia and no leukopenia and in the differential she has increased monocytosis. Her viral hepatitis serology panel shows hepatitis a IgM that is negative hepatitis B surface antigen and core antibody negative, hepatitis B surface antibody positive consistent with previous vaccination, and hepatitis C antibody negative. COVID-19 antigen was negative on admission 2/10/2021 she reports that she had a Covid PCR done in her office 5 days or so before admission that was also negative. She has been seen by our GI who evaluated her liver abnormalities. Imaging studies including a CT scan of 2/10/2021 showed chronic changes in the colon that could be consistent with inflammatory process such as ulcerative colitis, and a diffuse heterogeneous enhancement of the liver with nodularity that could be consistent with cirrhosis. She has a splenic varices and gastric varices which would make the diagnosis of cirrhosis certainly possible. An MRI of her abdomen on 2/11/2021 shows confirmation of the cirrhotic changes in the liver biliary dilatation or gallbladder abnormalities. There is evidence of portal hypertension. He also had a liver ultrasound that shows findings consistent with possible cirrhosis, including splenomegaly, hepatomegaly, and GB sludge. Alpha 1 antitrypsin, LKM antimitochondrial and anti-smooth muscle antibodies are negative. ANA and ANCA are pending. CMV and EBV PCR are pending. Given the unclear underlying etiology of her liver abnormalities, she had a liver biopsy. Result-Suggestive of NASH and confirms F4 cirrhosis. The patient was a started on Cipro and Flagyl empirically because of the findings on the colon suggestive of possible cholangitis. She has normal renal function. She has had no tick bites, no exposure to animals, no external factors consistent with atopic dermatitis or allergic type of rash. She reports that before admission, she had normal platelets about 1 or 2 years ago when she was tested, as well as normal liver function test. She reports that she has had some mild epistaxis as well as bleeding from her lips. She has some anorexia, she has had some looser stools but has been clear without obvious blood and she has had no hematuria. EGD on 15FEB2021- mild portal hypertensive gastropathy. Low risk esophageal varices. Labwork 15FEB2021- AST 173/ALT 64/Alk Phos 235/Plt 109/ Discharged on 02/15/2021 to home with plans for follow-up with GI and PCP. Prescribed Prednisone with taper off after 28 days. Follow-up appointment has not yet occurred as of the day this report is submitted(2/19/2021).
39 2021-02-21 redness, itchy skin, rash macular Patient reported itching on chest, red blotchy spots present. Reported itching in palms and all over... Read more
Patient reported itching on chest, red blotchy spots present. Reported itching in palms and all over. Patient evaluated by RN. Denied Shortness of breath or respiratory distress. Medical director was notified and Benadryl 50 mg was given. Patient tolerated this well. Vital signs were taken. Heart rate was-80, SPO2 -100 %, Blood Pressure was 118/72. Itching improved and patient was released after being observed.
39 2021-02-21 injection site swelling The day after receiving the vaccine the patient experienced swelling from the site of the injection ... Read more
The day after receiving the vaccine the patient experienced swelling from the site of the injection upward into her neck and face. Patient took Benadryl which relieved some of the swelling but slight neck edema and anterior cervical lymphadenopathy remains.
39 2021-02-21 itchy skin, hives Welts on trunk, generalized pruritus, tingling on lips. Trapsorted to ED. Contacted by allergy - dec... Read more
Welts on trunk, generalized pruritus, tingling on lips. Trapsorted to ED. Contacted by allergy - declined consult.
39 2021-02-22 itchy skin 2/2/2021- 1 day after vaccination, Pt. noted swollen upper lip (swelling greater than lower lip). Sl... Read more
2/2/2021- 1 day after vaccination, Pt. noted swollen upper lip (swelling greater than lower lip). Slight itching. 2/3/2021- patient noted blister on top lip open with blood and body aches started and lasted until 2/16. Pt. did mention during clinic that she does develop a similar reaction when she eats salmon- but does not have blisters on her lip. She has also never had a cold sore before.
39 2021-02-22 hives, itchy rash, rash Headache for 2 days Body aches for 3 days Striking Nerve pain in my keloid under right breast after... Read more
Headache for 2 days Body aches for 3 days Striking Nerve pain in my keloid under right breast after first injection and second injection Body aches for 3 days Nauseous day 3 Dizzy day 2 and 3 Hives/itchy rash started day 2 and currently still have itching rash all over body.
39 2021-02-22 injection site pain Pain at injection site, immediate but worsened w time, mild the next day. Nausea, chills, malaise, ... Read more
Pain at injection site, immediate but worsened w time, mild the next day. Nausea, chills, malaise, muscle and joint pain-started 15 hours after vaccine and lasted about 4-5 hours Fever up to 101.2- after nausea mostly resolved, lasted overnight Headache -24 hours
39 2021-02-23 itchy skin, redness, hives, skin warm 1 Welt/hive (redness, hot, itching, some raised area in center). Mild scratchy throat but unable to ... Read more
1 Welt/hive (redness, hot, itching, some raised area in center). Mild scratchy throat but unable to tell if from thirst from 45 min drive with no fluids or from vaccine. Observed for 30 min instead of standard 15. Given bottled water to drink. Released to work. Symptoms lasted about an hour from vaccination.
39 2021-02-23 injection site rash, rash with redness, redness, rash 2 days after the vaccine I developed a rash around the injection site 2/6/2021. After three days the... Read more
2 days after the vaccine I developed a rash around the injection site 2/6/2021. After three days the rash was gone without treatment. Then on 2/14/2021 I started feeling burning pain all over my neck and chest. It was slightly red that night. The next morning my chest, neck, and upper back had a red rash . My chest was the worst of it. Felt like a chemical burn . I went to the Doctor on 2/17/2021 and was told it was a delayed hypersensitivity reaction to the vaccine. I continued to take Benadryl, Zyrtec and was given Kenalog. On Sunday 2/21/2021 the pain was so pain and the rash was only getting worse and now on my face so I went to urgent care. There I was given a steroid ( prednisone) , derma smoothe and Pepcid. It has been 10 days and no improvement yet.
39 2021-02-23 itchy skin tongue numbness; weird taste; persistent allergies; itchy face; This is a spontaneous report from a ... Read more
tongue numbness; weird taste; persistent allergies; itchy face; This is a spontaneous report from a contactable health care professional (patient). A 39-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982, expiry date unknown), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included pre-diabetes and allergies to penicillin both from an unknown date and unknown if ongoing. The patient concomitantly received cetirizine hydrochloride (ZYRTEC) as pre-medication and Lexi pro (as reported). The patient received the first dose of BNT162B2 (lot number: EL0142, expiry date unknown), intramuscular on 30Dec2020 at 10:30 AM on the left arm for COVID-19 immunization where the patient immediately after experienced metallic taste in mouth followed by itchy throat that felt constricted. Prior to vaccination, the patient has not had COVID-19. The patient has not been tested for COVID-19 post vaccination. The patient was premedicated with Zyrtec and 15 minutes after second dose had tongue numbness and weird tast on 20Jan2021 at 16:15 and itchy face started hours later and then continued with persistent allergies every day since the second dose until present was placed on oral steroid. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received oral steroid and Benadryl as treatment for the events. The outcome of the events was recovering.
39 2021-02-24 injection site pain Pain at the injection site - evening of injection and 2 days following; Headache - morning after inj... Read more
Pain at the injection site - evening of injection and 2 days following; Headache - morning after injection, continuing 48+ hours after onset
39 2021-02-25 injection site pruritus, injection site pain 11 hrs post vaccination - intense fatigue, fever (up to 101.3F), chills, migraine, myalgia, joint pa... Read more
11 hrs post vaccination - intense fatigue, fever (up to 101.3F), chills, migraine, myalgia, joint pain and mild injection site pain 30 hrs post vaccination - most of above side effects resolved expect for migraine and occasional myalgia; however, began to experience nausea, bloating, stomach cramps, slight itchiness at injection site 52 hrs post vaccination - finally felt well enough to get out of bed but was still experiencing stomach cramps and migraine The day of the vaccination, I was able to work a full 8 hrs without experiencing side effects as they began 11 hrs post vaccination. I had to call off work for the following 2 days as I barely ate or slept during that time. Seventy-two hrs post vaccination, I was able to return to work with only one remaining side effect: lingering stomach cramps. Self treated with alternating doses of OTC Extra-strength Tylenol and Excedrin Migraine while I was experiencing migraine, fever, myalgia and joint pain. Also took Ultra-strength Rolaids as needed for bloating and stomach cramps.
39 2021-02-25 hives First, I got an extremely sore arm. The arm was so sore I could not sleep because every time I move... Read more
First, I got an extremely sore arm. The arm was so sore I could not sleep because every time I moved it hurt enough to wake me up. The next day (~midday) I broke out in severe hives. At around 12.20 I became very, very sleepy and I lost my voice. At around 12.30 my partner noticed my face was swelling (around my jaw and cheeks).
39 2021-02-25 injection site pain Rapid heartbeat (104-110) shortly after injection, arm hurt at injection site a few hours later (las... Read more
Rapid heartbeat (104-110) shortly after injection, arm hurt at injection site a few hours later (lasted for 2 days), fatigue and felt off the next day, felt anxiety and short periods of racing heart for 1.5 weeks after dose.
39 2021-02-25 rash convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her... Read more
convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her throat felt like it was on fire; shaking uncontrollably/ arms and legs were shaking; Her speech was slurred, she could not communicate; Stuttering; dysphagia; tongue was falling to the side/mile was droopy on the right side/right arm- she would try to move it but it would not go/right leg was almost paralyzed; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 09Feb2021 18:10 at a single dose for COVID-19 immunization. The patient had no relevant medical history. She was healthy and takes no medications. The patient got the vaccine Tuesday night at 6:10 PM. She waited in the parking lot where she got it, which was through (School Name). She had a severe reaction and had to receive an Epi Pen. This reaction occurred maybe 10 minutes after she got it. She had not left the parking lot yet, so it was prior to the 15 minutes. She broke out in a rash, her chest felt really heavy like someone was sitting on it, like an elephant, and her throat felt like it was on fire which is what is started as, then it went to her ears. From there, it escalated. She had gotten out of her car and took her sweatshirt off, she thought she was just hot. As soon as she got back in the car and as soon as she got in she started convulsing uncontrollably and shaking uncontrollably. Two ladies she works with had parked next two her on both sides and they noticed this and went to get the emergency squad. She did not lose consciousness. She could still hear everything but her arms and legs were shaking, and her right leg was shaking and stuck. The emergency squad had to help her out of the car. The ambulance gave her an Epi Pen injection and the squad took her to the hospital. Her speech was slurred, she could not communicate. She was stuttering the same thing over and over. She had a CAT scan with contrast and the stroke team decided she needed TPA - the stoke medication. They administered that and admitted her to the hospital Tuesday night. Wednesday she had an MRI, echocardiogram and another CAT scan and they released her to come home last night. She is still having lingering effects. Her speech is back. Her arm movement is back. The reason they treated her as a stroke patient, they said, is because when they told her to stick her tongue out, she had dysphagia - her tongue was falling to the side, and her smile was droopy on the right side. Her right arm- she would try to move it but it would not go. And her right leg too. She could do everything on her left side and nothing on her right side. She was conscious and could hear but could not get anything to work. After receiving the TPA, Wednesday when she woke up, she was being checked on every 30 minutes throughout the night, she was able to speak and communicate. She will still stutter and have slow words but it is way better and she can communicate. Her right arm is able to move and she can use it but her fine motor is hard. Like writing stuff is a challenge. She also has a walker. Her right leg is almost paralyzed, it drags beside her as she walks. She can move but has to really concentrate to get going. She has not reached out to her doctor yet. She was admitted to the hospital and had a bunch of tests done. The Epi Pen gave her stroke like symptoms. They were not sure in the hospital if it was actually a stroke based on her 2 MRI's and CAT scans. It did not look like a stroke from those but they think that the Epi Pen and the stress it puts into your body made her body shut down. Which the Epi Pen they said can cause stroke like symptoms. They were unsure as they have seen multiple things with the vaccine come in over the last few weeks. They told her she would need to work on the therapies out-patient. She will have to have PT/OT for lingering effects she was suffering from. Outcome of events was recovered with sequelae.
39 2021-02-25 hives ~10 minutes after the vaccine I broke out in hives which spread over by body and continued for ~ 5 d... Read more
~10 minutes after the vaccine I broke out in hives which spread over by body and continued for ~ 5 days.
39 2021-02-26 dry skin, injection site pruritus, skin peeling, injection site redness Entire deltoid where I received the injection is red, itchy, and is suffering from dry peeling skin.... Read more
Entire deltoid where I received the injection is red, itchy, and is suffering from dry peeling skin. I still went for my second dose since I read about covid arm and they still recommend getting a second dose. I received my second dose on 2/23/21. The symptoms are persisting and have increased.
39 2021-02-27 redness 4-6 painful swollen lymph glands in left armpit. Can see redness as well as a physical lump of sever... Read more
4-6 painful swollen lymph glands in left armpit. Can see redness as well as a physical lump of several. Treating with advil & hot compress to relieve pain. Noticed tenderness in armpit 1-2 days after vaccine #2, then went away. But has since returned worse than previously.
39 2021-02-27 hives On third day after 2nd vaccine was given, urticaria appeared throughout my body, along with tongue ... Read more
On third day after 2nd vaccine was given, urticaria appeared throughout my body, along with tongue swelling, wheezing, flushing, and eye irritation. Because my daughter suffers from allergic reactions, I knew to immediately administer Benadryl. I also took an additional dose of Zyrtec and Pepcid, which helped temporarily and symptoms subsided when I called my primary care doctor. I had a virtual visit, and she then prescribed Medrol.
39 2021-02-27 skin warm, rash with redness, itchy skin Patient c/o left arm itching and feeling "hot" noted to have erythematous rash left neck no SOB, it... Read more
Patient c/o left arm itching and feeling "hot" noted to have erythematous rash left neck no SOB, itching, chest pain, or stridor.
39 2021-02-27 injection site pain Started feeling flu-like symptoms close to 10 hours after I got the 2nd Pfizer shot, specifically ac... Read more
Started feeling flu-like symptoms close to 10 hours after I got the 2nd Pfizer shot, specifically aches and pains, chills, sharp shooting pains in parts of body, and headache. Had a low-grade fever (between 100-101) over 36 hour-period. Still feeling achy and tired within 48 hours of receiving the vaccine, but my fever is gone. I also have arm soreness and my lymph nodes under the armpit of the arm where I received the shot is swollen.
39 2021-02-28 shingles, pain of skin 36 hours after vaccination was received, I woke with painful stiffness on left side of neck and back... Read more
36 hours after vaccination was received, I woke with painful stiffness on left side of neck and back of head. Swollen occipital lymph node on left side. As time progressed, pain spread across scalp and neck. Swelling and pain followed. I went to visit my primary care physician today (Monday, March 1st) and was diagnosed with SHINGLES.
39 2021-02-28 itchy skin, hives Itchy neck, arms, lower half of face; Hives on both arms.; Burning headache; This is a spontaneous r... Read more
Itchy neck, arms, lower half of face; Hives on both arms.; Burning headache; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL8982), via an unspecified route of administration in the right arm on 27Jan2021 08:45 at a single dose for covid-19 immunization. Medical history included hypothyroid, allergies to nausea medication and COVID 19. Concomitant medication included levothyroxine. On 27Jan2021 12:00, the patient experienced itchy neck, arms, lower half of face., hives on both arms and burning headache. The patient did not receive treatment for the events. The events were assessed non-serious. The outcome of the events was not recovered.
39 2021-02-28 itchy skin, hives Within 24h of 2nd dose of vaccine experienced chills, fatigue. 3 days post vaccine (2hours after ta... Read more
Within 24h of 2nd dose of vaccine experienced chills, fatigue. 3 days post vaccine (2hours after taking first dose of drospirenone) experienced itching of neck, face, hives on face, facial swelling, mild nausea/abdominal pain that resolved with BM. Facial swelling, itching, hives took 3-4 days to improve abd required oral steroids, Benadryl, zyrtec, famotidine.
39 2021-03-01 rash All over rash that started on hands and covers most of the body. No new detergents, soaps, foods. ... Read more
All over rash that started on hands and covers most of the body. No new detergents, soaps, foods. No history of allergies to anything. At present, steroids are not working. IM steroid given 2/25 with oral medrol dospak.
39 2021-03-01 redness Burning and redness in both armpits, fever of 100.0 Fahrenheit, headache, fatigue.
39 2021-03-01 redness breast infection; left breast pain/breast became sore; breast became red, sore, warm and had a line ... Read more
breast infection; left breast pain/breast became sore; breast became red, sore, warm and had a line traveling to my armpits; breast became red, sore, warm and had a line traveling to my armpits; breast became sore, warm and had a line traveling to my armpits; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second single dose (BNT162B2, Pfizer, Solution for injection, lot number: EL3249, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 19Jan2021 06:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient medical history was not reported. There were no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There were no other medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (Pfizer, lot number: EL1284) on 30Dec2020 06:00 (vaccine location: left arm). On 24Jan2021, the patient started to have left breast pain. Her breast became red, sore, warm and had a line traveling to the armpit. The doctor stated the red area felt full. The patient was treated for a breast infection. Treatment received for the adverse events included: Clindomycin. The events were considered non-serious by the reporter. The events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient had not been tested for COVID-19. The events recovered on an unspecified date in 2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2and the event mastitis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-03-02 injection site discomfort Client c/o a nerve discomfort from the vaccine site to the side of Left neck up to the jaw area. Adv... Read more
Client c/o a nerve discomfort from the vaccine site to the side of Left neck up to the jaw area. Advised client for another 15 minutes of observation. Client stated OK. NP was made aware and NP spoke with client. BP was taken at 146/84. Ox at 98% HR at 76, temp 98.7. Client was monitored for another 15 minutes BP was taken 10 minutes later with 143/83, Ox at 98, HR 75. Patient stated that she is okay. stated that the nerve discomfort is no longer present. Client left clinic stable with steady gait.
39 2021-03-02 itchy skin, redness One week after each vaccine, my skin beneath my right eye started swelling, getting very red, and ve... Read more
One week after each vaccine, my skin beneath my right eye started swelling, getting very red, and very itchy. I look like I've been punched in the face. The first time, it lasted about 4-5 days before it went away. My vaccine date for dose #1 was Friday 1/29/21 and the swelling started on 2/5 (the following Friday). My second vaccine date was Monday 2/22 and the skin beneath the eye started reacting 3/2 (Tuesday). It itches a huge amount. The skin beneath the eye is dark red, and puffy. The skin beneath the left eye is normal.
39 2021-03-02 hives Tachycardic, hr 112; hives on both arms, chest, face.; Lips were tingly; This is a spontaneous repor... Read more
Tachycardic, hr 112; hives on both arms, chest, face.; Lips were tingly; This is a spontaneous report from a contactable other hcp. A 39-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 16:00 at single dose, right arm for covid-19 immunization. Medical history included Anti Myelin oligodendrocyte glycoprotein(MOG) disease. Known allergies included prednisone, methyl prednisolone. Concomitant medication included cyclobenzaprine, celecoxib and duloxetine hydrochloride (CYMBALTA). There were no other vaccine in four weeks. The patient previously received first dose of bnt162b2 for covid-19 immunization. The patient had hives on both arms, chest, face. Lips were tingly. Tachycardic, HR 112. The patient took 75 mg diphenhydramine hydrochloride(BENADRYL) and became slightly better. Adverse events start date was 25Feb2021 16:30. Events resulted in [Life threatening illness (immediate risk of death from the event)]. The outcome of the events were recovering. The patient had no COVID prior vaccination. There was no COVID tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
39 2021-03-02 itchy skin VACCINE GIVEN @ 111O AM. APPROXIMATELY 10 MINS POST INJETION PT C/O ITCHING TO FACE. NO EDEMA, SOB,... Read more
VACCINE GIVEN @ 111O AM. APPROXIMATELY 10 MINS POST INJETION PT C/O ITCHING TO FACE. NO EDEMA, SOB, VERTIGO REPORTED. 50MG PO BENADRYL GIVEN TO PATIENT. PATIENT KEPT 50 MINUTES FOR OBSERVATION LEFT IN STABLE CONDITION.
39 2021-03-02 injection site pain post vaccine - c/o pain to right arm and back, feeling tired and weak. and "out of it"
39 2021-03-03 hives, injection site hives Hives developed overnight. She woke up and notices hives at injection site, on neck and on face. She... Read more
Hives developed overnight. She woke up and notices hives at injection site, on neck and on face. She took zyrtec and put benadryl ointment on hives. Hives went away. Employee states she felt tired and achy mid day 3/4/21. Employee has follow up schedule with PCP 3/4/21.
39 2021-03-04 itchy skin Coughing, diffuse itching and feeling of tightness in chest. Started at 7:15 pm and was persistent.
39 2021-03-04 injection site pain I had a very sore arm the night following my injection. Then I woke up with chills, fever, and could... Read more
I had a very sore arm the night following my injection. Then I woke up with chills, fever, and couldn?t sleep. The next day I had chills, fever, tired, sore arm, and spit on my left breast that hurt more than the injection sight. That night I had a headache that was not going away with medicine and couldn?t sleep. I also continued to have fever. The next day I still have breast pain, fatigue, and dizziness.
39 2021-03-04 rash with redness, blister Less than 48 hours after I suddenly noticed a raised blister on the inside of my cheek. When I showe... Read more
Less than 48 hours after I suddenly noticed a raised blister on the inside of my cheek. When I showed my mom she said it looked bright red. It was a symmetrical about the size of a pencil eraser raised spot. It didn?t hurt or itch. That evening raised blister went away and looked like asymmetrical blood rash under the skin. The next day you couldn?t see anything on inside of cheek at all.
39 2021-03-05 rash, itchy skin, hives Rash, hives, and itchy rash on core body. Spread from neck down all the way to lower back. On both s... Read more
Rash, hives, and itchy rash on core body. Spread from neck down all the way to lower back. On both sides of core and front and back. Did not extend to arms or legs. Hives lasted 72 hours despite taking Benadryl and Claritin.
39 2021-03-05 hives The morning after I broke out in hives on my legs after taking a run. I?ve never had hives before in... Read more
The morning after I broke out in hives on my legs after taking a run. I?ve never had hives before in my life. I took Benadryl and they went away. On Tuesday the 2nd after a run again, I had a smaller outbreak of hives again. They went away on their own.
39 2021-03-05 rash, redness, rash with redness The shot was given well and I waited for 30 minutes after at the facility. No issues at that time. A... Read more
The shot was given well and I waited for 30 minutes after at the facility. No issues at that time. About 2.5 hours later I got a red rash on both arms and hands ( looks and feels like sunburn but it?s not). Rash persists off and on since ( even today). I?ve had a temperature of about 99 off and on for several days. Only my head and face are flushed and hot, but rest of me cold. I have soreness in both breasts. My left shoulder and breast had small sores ( looks like small scrape but no injury occurred). Those areas sting internally with some pain and redness. Feels like bruise but nothing visible. I?ve had fatigue almost every day. I have brain fog ( can?t spell simple words, forgetting words, lack of focus).
39 2021-03-05 injection site redness, injection site warmth, injection site swelling, injection site pain, injection site mass, injection site hardening Very hard, swollen, hot, red lump around injection site. It is VERY painful and continues to grow. I... Read more
Very hard, swollen, hot, red lump around injection site. It is VERY painful and continues to grow. It is approximately 3 1/2 inches by 3 inches. And about 1/2 inch out from my muscle.
39 2021-03-06 injection site swelling At injection site no redness or visible swelling, but when I touch it I can feel it is swollen direc... Read more
At injection site no redness or visible swelling, but when I touch it I can feel it is swollen directly underneath the spot where the vaccine was injected.
39 2021-03-07 rash macular During end of 30 minute observation time veteran's arms appeared erythemic and splotchy. During ass... Read more
During end of 30 minute observation time veteran's arms appeared erythemic and splotchy. During assessment, she stated that she was feeling like her heart was racing, blurry vision, and dizzy. Denies SOB, no facial swelling noted, swallowing water without difficulty. Vital signs completed at approx. 1344: 194/116, 113 bpm, 16 rr. Repeated 5 minutes later as 176/113, 105 bpm. She later reported that symptoms first began about 15 minutes into timer. She was taken to ER, given IV Benadryl, monitored, and discharged home.
39 2021-03-07 bruising, rash Erythema Nodosum, both knees/legs. Red, swollen bumps. Hot to touch, painful. Bruising and swelli... Read more
Erythema Nodosum, both knees/legs. Red, swollen bumps. Hot to touch, painful. Bruising and swelling
39 2021-03-07 bruising, injection site bruising Massive bruising at the injection site that is still there almost three weeks after vaccination. Oth... Read more
Massive bruising at the injection site that is still there almost three weeks after vaccination. Other mysterious bruises on my other arm and now legs.
39 2021-03-07 hives did not have full anaphylaxis; a sense of her throat swelling; hives; This is a spontaneous report f... Read more
did not have full anaphylaxis; a sense of her throat swelling; hives; This is a spontaneous report from a contactable physician. A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced "a sense of her throat swelling" and hives 1 hour after the vaccination occurred. The patient received 1 dose of Benadryl and Tylenol and "felt ok." The physician commented that the patient did not have full anaphylaxis and was asking if it would be safe for the patient to receive the second dose of the vaccine at the time of report. The outcome of the events was recovering. Information on the lot/batch number has been requested.
39 2021-03-08 hives 30 minutes after pain in arm and shoulder, an hour and half later headache and fever 101, by 2:30pm ... Read more
30 minutes after pain in arm and shoulder, an hour and half later headache and fever 101, by 2:30pm hives behind right ear, 30 minutes later hives behind left ear. Applied Benadryl cream on areas and went away in 30 minutes but then hives appeared in face around eyes and eyebrows. Applied cream there and within 30 minutes hives went away. An hour later they reappeared on cheeks. Applied cream and hives went away. However fatigue worsened but fever reduced to 99.
39 2021-03-08 rash Patient experienced rash and tachycardia after receiving vaccine. Patient was given Benadryl 50 mg ... Read more
Patient experienced rash and tachycardia after receiving vaccine. Patient was given Benadryl 50 mg and Epinephrine 0.3mg. Patient responded well to medications and sent home with Prednisone Rx.
39 2021-03-09 hives, itchy skin At 16:07, 12 minutes following administration of the Pfizer COVID-19 vaccine (dose #2), patient pres... Read more
At 16:07, 12 minutes following administration of the Pfizer COVID-19 vaccine (dose #2), patient presented with a swollen lip, hives, and itching. Patient denied shortness of breath, difficulty breathing, tightness in throat. 25 mg diphenhydramine was administered orally at 16:08. Patient was admitted to ED for care where IV methylprednisolone, IV diphenhydramine, and IV famotidine were administered between 16:30-16:36. Patient reported decreased swelling and itching at 17:15. Provider at bedside and cleared for discharge with home meds at 18:00.
39 2021-03-09 itchy skin, rash Flu like symptoms; Full body rash with itching; Full body rash with itching; localized arm pain with... Read more
Flu like symptoms; Full body rash with itching; Full body rash with itching; localized arm pain with ancillary edema x 5 days; localized arm pain with ancillary edema x 5 days; This is a spontaneous report from a contactable nurse (patient). The nurse reported 2 reports for same patient, same product. This is the second report. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ3246), intramuscular in the right arm on 12Jan2021 08:30 AM at single dose for covid-19 immunisation. Known allergies included Tramadol and Lexapro. No other medical history. Concomitant medication (Other medications in two weeks) included VITAMIN B complex (B COMPLEX), collagen marine, methylsulfonylmethane (MARINE COLLAGEN PEPTIDES WITH MSM), saw palmetto [serenoa repens] and zinc. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685, administrator route=Intramuscular, vaccine location=Left arm) on 22Dec2020 at age of 39-year-old for covid-19 immunisation and experienced general malaise with nausea and diarrhea, localized pain 3-4/10 after first dose x 5 days. The patient experienced full body rash with itching, localized arm pain with ancillary edema x 5 days. Flu like symptoms. After second dose in 2021. Treatment for events included Antihistamine. No Covid prior vaccination. The outcome of events was recovering. Unknown if Covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123153 same patient, same product (first dose), different events.
39 2021-03-09 bruising, rash Vaccine was administered in left arm on Sunday. Rash/bruising occurred 2 days later on Tuesday morni... Read more
Vaccine was administered in left arm on Sunday. Rash/bruising occurred 2 days later on Tuesday morning on opposite right arm. There is no pain or itching to the impacted area, Resembles bruising or a birth mark.
39 2021-03-09 injection site warmth When the injection was placed I experienced deep pain inside my shoulder. Within 3 hours my shoulder... Read more
When the injection was placed I experienced deep pain inside my shoulder. Within 3 hours my shoulder was frozen in pain and unable to move. I used ice and anti-inflammatory medication with no relief. I was unable to move my shoulder and could not complete daily self care tasks like brushing hair, changing clothes, cooking or driving. I could not drive to work the next day and had to use sick leave. I was in a high level of pain. I woke up crying throughout the night for three nights due to pain. I sought care at unspecified Urgent Care and was told that it was just sore and I need to keep moving the shoulder and apply heat. I was given an RX for Cephalexin, an antibiotic. Dr. indicated the injection site was warm to the touch. By Wednesday morning, there has been a slight improvement in pain and mobility. I am able to hold my arm straight down as opposed to keeping the elbow bent and tucked in. Still cannot raise my arm at all from the shoulder joint.
39 2021-03-09 rash Within 4 hours a rash between my inner thighs appeared.; This is a spontaneous report from a contact... Read more
Within 4 hours a rash between my inner thighs appeared.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration in the left arm on 04Feb2021 at 14:15 (02:15 PM) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no other vaccine in four weeks. The patient's medical history included diabetes, and the patient had Covid prior to vaccination. The patient had no known allergies. Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), semaglutide (OZEMPIC), and prenatal vitamin. Within 4 hours (on 04Feb2021 at 06:30 PM) a rash between her inner thighs appeared. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included steroid cream and diphenhyramin HCl (BENADRYL). The patient has not been tested for Covid post vaccination. The outcome of the event was not recovered. Information on the batch/lot number has been requested.
39 2021-03-09 rash with redness, itchy skin Within 5 minutes of injection,, Red rash strip down middle of face from forehead to chin, Face Flush... Read more
Within 5 minutes of injection,, Red rash strip down middle of face from forehead to chin, Face Flushing, Face itching. Within 1 hour of injection,, Sore joints. Treated with OTC benadryl and Ibuprophen Symptoms Resolved in 2 hours
39 2021-03-10 injection site pain Approximately 2.5 hours after injection, a fiery pain started at the injection site, went up to the ... Read more
Approximately 2.5 hours after injection, a fiery pain started at the injection site, went up to the shoulder, and down the left side of my chest. This was accompanied by chest tightening and slight shortness of breath. The pain ended after about a minute while I was getting my phone to call an ambulance because it was so bad. I chose not to complete the call as the pain began to fade. The chest tightening and breathing issue resolved a couple minutes later. My arm was extremely painful the rest of the day (achy, not the fiery sensation). I have never had a reaction like this to any vaccine or medication.
39 2021-03-11 hives, itchy skin After about 18 minutes (patient under observation for 30 minutes) the patient started to complain of... Read more
After about 18 minutes (patient under observation for 30 minutes) the patient started to complain of itching on face, arms, and swelling feeling in mouth. she also c/o shortness of breath. On observation her oxygen saturation and blood pressure remained stable. she was brought into the office from the waiting area and given 25 mg benadryl IM. SHe was observed for 15 minutes and vitals were monitored and remained stable. she subsequently continued to have itching in throat and around mouth and hives were noted on arms and neck. her lips appeared starting to have edema. She was given one dose of epipen 0.3mg im in thigh and 911 was called. she was transported to er for further treatment and observation. she reported to us several hours later that she remained stable and was discharged on prednisone, famotidine, and cetirizine.
39 2021-03-11 injection site pain I experienced: fever, tiredness, feeling unwell, headache, muscle pain, joint pain, injection site ... Read more
I experienced: fever, tiredness, feeling unwell, headache, muscle pain, joint pain, injection site pain, rapid heartbeat. These gradually subsided. By about 6 p.m. on March 11, I was just tired. On March 12, I felt better. The only treatment pursued was rest.
39 2021-03-11 rash, itchy skin Rash and itching all over body. First was given Benadryl, Zyrtec and famotidine. Second trip to er w... Read more
Rash and itching all over body. First was given Benadryl, Zyrtec and famotidine. Second trip to er was given hydroxyzine hcl
39 2021-03-11 injection site pain, injection site warmth, injection site rash, injection site redness Started having symptoms the next morning with nausea, then that same night had soreness at injection... Read more
Started having symptoms the next morning with nausea, then that same night had soreness at injection site with rash (red) around the injection site and warm to touch, vomiting, diarrhea, fever (102), chills, severe muscle and joint pain, fatigue. Just took tylenol and rest as much as I can. Felt better 3/12, just have the sore arm, redness, and warm to touch around the injection site.
39 2021-03-13 injection site swelling, hives, injection site redness Covid arm, large red swollen welt on arm 8 days after injection
39 2021-03-13 hives I developed hives from head to toe. It didn't really itch or feel uncomfortable. Went to immediate... Read more
I developed hives from head to toe. It didn't really itch or feel uncomfortable. Went to immediate care and got a steroid shot and some steroid pills. It started to disappear on Tuesday morning.
39 2021-03-14 hives 12 minutes floowing vaccination (16:07) patient presents with swollen lips, hives on neck and compla... Read more
12 minutes floowing vaccination (16:07) patient presents with swollen lips, hives on neck and complaint of mouth numbness. Patient denied difficulty breathing, swollen throat or SOB. Pharmacist adminsted 25 mg diphenhydramine po at 16:08. Patient transferred to ED where she received Solumedrol 125 mg IV x1, Famotidine 20mg IV x1 and DIphenhydramine 25 mg IV x1. Patient stabilized and discharged home at 18:00.
39 2021-03-15 injection site reaction Muscle soreness at site of injection Muscle fatigue General fatigue
39 2021-03-15 skin burning sensation felt intense heat in her armpit lymph nodes on the right side; streaks of heat along the back of her... Read more
felt intense heat in her armpit lymph nodes on the right side; streaks of heat along the back of her scalp; heat in her chest; right side felt numb from her leg to her shoulder; hot flashes; This is a spontaneous report from a contactable consumer. A non-pregnant 39-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 19Jan2021 at 39-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient's medical history included heart murmur, Latex allergy; both from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications were not reported; and no other medications were received within two weeks of the suspect vaccine. On 19Jan2021, the patient experienced: felt intense heat in her armpit lymph nodes on the right side (non-serious), streaks of heat along the back of her scalp (non-serious), heat in her chest (non-serious), right side felt numb from her leg to her shoulder (non-serious), hot flashes (non-serious). The clinical course was reported as follows: The patient, ten minutes after the vaccination, felt intense heat in her armpit lymph nodes on the right side. This was followed by streaks of heat along the back of her scalp, and heat in her chest. After about an hour, the right side felt numb from her leg to her shoulder. The patient's "body stayed that way for about 20 hours." The patient also experienced hot flashes, which was not something that she ever had before. The patient feared getting the second dose because her body felt so off after the first dose. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination with the suspect vaccine. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
39 2021-03-16 injection site redness Big red circle at injection site, still there and growing larger 13 days later.
39 2021-03-16 redness Left sided arm and facial redness and numbness for 2 hours that then went away with no other issues
39 2021-03-16 injection site discomfort, injection site tingling, injection site numbness Within minutes of receiving the vaccine (I was on the phone at the time and noted that my left inner... Read more
Within minutes of receiving the vaccine (I was on the phone at the time and noted that my left inner wrist felt internally hot). My left arm from injection to fingertips felt internally as if I was injected with peppermint oil. A hot/overly cold prickly feeling started and then proceeded to feel hotter and my arm felt tingly, numb, as if an epidural was put on my left arm or it fell asleep. These feelings were internal (no rash or external redness). I also felt a bit of this same on my lower left jaw (again no outside rash or redness just inside feeling). I reported it immediately to the pharmacist who administered the shot and he said there looks to be no redness and that after my 15 minutes was up it was ok to go home. It is 5 hours now after the shot and it feels as if a nerve has been hit - my arm feels very internally cold. Fingers and arm functions fine, but it feels like its slightly detached from myself (none of this occurs anywhere other than the injection site down to fingertips and left jaw bone).
39 2021-03-16 rash with redness, rash macular flu-like (no fever) for 24 hours, rash on stomach (not raised, just red & blotchy) lasted 2.5 weeks
39 2021-03-16 rash with redness, hives rash with hives and redness.
39 2021-03-18 rash Rash all over body , especially neck
39 2021-03-18 hardening Right lymph node under collar bone is swollen, hard, and tender. Muscles on top of right thigh are ... Read more
Right lymph node under collar bone is swollen, hard, and tender. Muscles on top of right thigh are painful to touch (feels like a very deep bruise).
39 2021-03-19 injection site warmth, injection site swelling, injection site redness Day 2 Chills Muscle Aches through entire body including fingers and toes Headaches Nausea Temperatur... Read more
Day 2 Chills Muscle Aches through entire body including fingers and toes Headaches Nausea Temperature 102.4 Completely unable to move and take care of my children Day 3 Headaches Arm Swelling all the way under armpit Red and Warmth under skin at injection site
39 2021-03-19 redness, hives, bruising Generalized urticaria, diffuse erythematous, blue bruise like marks on legs.
39 2021-03-19 hives Hives on both arms, abdomen, back, legs, chest, neck. Not responsive to Benadryl .
39 2021-03-20 injection site tingling, injection site warmth At exact time of infection, whole left arm started getting tingly and warm, especially from crook ... Read more
At exact time of infection, whole left arm started getting tingly and warm, especially from crook of elbow down through fingers. My usual comfortable watch felt tight and annoying. Was able to walk to observation area, then started getting dizzy and light- headed. Still had warm, tingly feeling in arm that received injection. My normal resting heart rate is 61 but now it was up to 111 per smart watch (possibly 121 but can't confirm since I was dizzy and blurry-eyed). In addition to tingly arm, racing heart, dizziness, I felt immediate fatigue and wanted to lay down and sleep. Also, had dull headache on left-side. Nurse sat me down and elevated my feet. Also got me some frozen peas for my forehead and neck. After 12-13 mintues, I started feeling better. She kept me under observation for full hour. Got better and went home. Heart rate remained elevated at 78-89 rest of evening. Dull headache remained on left- side only. Similar feeling to when wearing a tight pony tail and you take it out.
39 2021-03-20 vaccination site swelling, vaccination site rash, vaccination site pain, vaccination site redness The patient experienced redness, swelling, pain at injection site; The patient experienced redness, ... Read more
The patient experienced redness, swelling, pain at injection site; The patient experienced redness, swelling, pain at injection site; The patient experienced redness, swelling, pain at injection site; Skin rash;Red tender swollen hot itchy rash developed at the injection site; Fatigue; Body aches; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the left arm on 05Feb2021 12:15 (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunization. Patient had no other medical history. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included macrogol 3350 (MIRALAX) taken for an unspecified indication, start and stop date were not reported; OTC multivitamins and BCP. Six (6) hours after injection, (05Feb 2021 18:15) patient experienced fatigue and body aches lasting less than 12 hours. On 13Feb2021 12:00, the patient experienced redness, swelling, pain at injection site lasting about 4 days. Delayed skin rash. appeared starting on day 8 (13Feb2021 12:00), described as a red tender swollen hot itchy rash developed at the injection site. The outcome of events was reported as "not recovered". Patient did not receive any treatment due to these events. No follow-up attempts are possible. No further information is expected.
39 2021-03-21 itchy rash, rash, shingles - patchy, itchy rash developed. Diagnosed by dermatologist as shingles - 1 year old daughter had re... Read more
- patchy, itchy rash developed. Diagnosed by dermatologist as shingles - 1 year old daughter had received chickenpox vaccine on 3/12 as well
39 2021-03-21 injection site pain Day 0:Within a few hours, I felt extremely dizzy and had numbness in my extremities. I had trouble c... Read more
Day 0:Within a few hours, I felt extremely dizzy and had numbness in my extremities. I had trouble concentrating. By the evening, i felt like I had a mastiff sitting on my chest and was having trouble filling my lungs. I took a benadryl and tylenol before bed. Day 1: In the morning, I felt somewhat better, feeling like I had a 20lb dog on my chest. Severe fatigue (slept for 5 hours in the afternoon/evening). Headache. Day 2: Continued pressure in chest. Feeling of something stuck in esophagus. More severe fatigue (slept another 5 hours in the afternoon). Injection site still tender. Cough began at bedtime and continued through morning. Day 3 (today): continued pressure in chest and feeling of something stuck in esophagus. Loss of appetite. Severe fatigue. Ache down injection arm to wrist.
39 2021-03-21 itchy skin INITIALLY FELT AN ITCHING NEAR HER FOREHEAD/EYES. NO S/S OF ANGIOEDEMA. NO SOB, NO SCRATCHY THROAT. ... Read more
INITIALLY FELT AN ITCHING NEAR HER FOREHEAD/EYES. NO S/S OF ANGIOEDEMA. NO SOB, NO SCRATCHY THROAT. BLOOD PRESSURE AND HEART RATE ELEVATED. AFTER INITIAL ANXIETY OVER POSSIBLE REACTION, HER HEART RATE WAS DECREASED BUT BP REMAINED IN HYPERTENSIVE URGENCY RANGE.
39 2021-03-21 skin warm Immediately after injection I had a sore arm in a warm spot. And the following days I had a headache... Read more
Immediately after injection I had a sore arm in a warm spot. And the following days I had a headache and felt very under the weather with a low-dose fever. On Saturday 3/20, I started to get achy muscles and joints. On 3/21, I had around five incidents of diarrhea. Today, 3/22 I called my doctor about the joint and muscle pain. We decided constantly taking ibuprofen for a few dates is the course of treatment for now. I would consider it moderate pain, I?m struggling doing daily activities without pain intervention. Most of the pain is in my hips, knees, ankles, toes, and hands.
39 2021-03-22 redness 3:20 Client stated she felt hot and her neck was red. We took her out observation area and took bloo... Read more
3:20 Client stated she felt hot and her neck was red. We took her out observation area and took blood pressure. BP 130/88- P 75. The redness in her neck had spread to her face and ears. At the time a whelp had started forming on her right cheek. We put an ice pack on her neck and started to fan her. She stated that her face felt like it was swelling. 3:45 her redness had started to recede and she felt that her face was feeling better. We continued to monitor her symptoms and at 4:10 her spouse arrived to drive her home and the whelp was gone or right cheek, the redness had receded from her cheeks and ears. Her neck was not as red and she stated that she was not hot and she was able to return home.
39 2021-03-23 skin tightness Feeling tightness on the face for around 45 min. Blurred vision, very dizzy and unable to have good ... Read more
Feeling tightness on the face for around 45 min. Blurred vision, very dizzy and unable to have good balance for 6 days.
39 2021-03-23 injection site mass ROUND LUMP/MASS DEVELOPED ANTERIOR TO THE INJECTION SITE (LEFT DELTOID)
39 2021-03-23 injection site pruritus, skin discolouration, injection site swelling, injection site pain Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Cutaneous skin reaction on chest and thighs yellow and purple color
39 2021-03-23 itchy skin Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
39 2021-03-24 rash Feverish feeling with body temperature change of about 1 degree that lasted for about 6 hours on 3/1... Read more
Feverish feeling with body temperature change of about 1 degree that lasted for about 6 hours on 3/14/2021. Skin rash developed at the same time across face, neck and chest. Skin rash was not hives, but small pimple-like bumps. The rash lasted for about 7-8 days, with the 7th day starting to see the rash recede.
39 2021-03-24 itchy skin, rash Itching, swelling/rash 12-14h after first Pfizer vaccine. Second dose cancelled
39 2021-03-24 itchy skin Patient became itchy all over.
39 2021-03-24 itchy skin, injection site pruritus Patient reported feeling lightheaded and her left deltoid was itchy. At 1000 she had a sublingual 10... Read more
Patient reported feeling lightheaded and her left deltoid was itchy. At 1000 she had a sublingual 10 mg Zyrtec, at 1022 itching progressed to her abdomen, upper and lower back, more dizzy, lips felt heavy. At 1030 50mg Benadryl IM given. At 1100, itching, rash, and dizziness resolved.
39 2021-03-24 rash To whomsoever it may concern, I am writing to report a reaction to covid-19 Pfizer vaccine second d... Read more
To whomsoever it may concern, I am writing to report a reaction to covid-19 Pfizer vaccine second dose. My first dose was administered on feb 10th at the community College at 11:30 AM. My second dose was administered on March 2nd at 11:30 am at the same facility. On March 4th evening a rash started developing near my throat and it became prominent on March 5th. Attached please find the pictures of the day the rash started developing and subsequent days of it getting worse. It has been 20 days and the rash has not subsided despite applying local corticosteroid cream. Furthermore, it has extended to my face (left eye). Additionally, I have not changed my food intake , or used any new facial creams. I also only use hypoallergenic creams. Worried I showed my rash to a doctor who suspects that this could be an allergic reaction to the vaccination and asked me to report it to you as this may be considered important information. Therefore the email. Please let me know if there is anything I can do to be of further help. Sincerely
39 2021-03-25 redness, skin burning sensation About 45 minutes post vaccine my chest, neck, and face started to turn bright red and I had a horrib... Read more
About 45 minutes post vaccine my chest, neck, and face started to turn bright red and I had a horrible burning sensation as well as a scratchy throat. I went to a walk in minor care clinic and they gave me a steroid shot. The following day around 11:00 am the reaction spiked again and I went to the ER. While at the ER they gave me more steroids, benadryl, and pepcid and observed the reaction for a couple hours. The redness got better and the burning subsided but my skin was still a pinkish tone. Today, the third day, I have a tingling feeling in my skin where the reactions occurred and they are bright pink. I am on oral steroids and pepcid for a week.
39 2021-03-25 itchy skin Client received her first dose of Pfizer vaccine and during the post-vaccination wait period, she re... Read more
Client received her first dose of Pfizer vaccine and during the post-vaccination wait period, she reporting itching on her arms and upper chest. On examination, she did not have any hives, redness or swelling of the skin. Vital signs: BP=173/116, Pulse=98, regular respiration ? not labored. Client stated that she has high blood pressure, but had taken her medication in the afternoon. She was asked to wait for an additional 15 minute to see if her symptoms would improve, but it remained the same. She did not want the EMT to be called but stated that she preferred a friend to pick her up, after she was advised that it was prudent to be evaluated at the hospital. ?911? was called and Medic arrived, evaluated her and transported her away at 16:45 hours.
39 2021-03-25 itchy skin, redness Pt received Covid-1 vaccine. About 15 minutes after shot was given pt waved down parking attendant a... Read more
Pt received Covid-1 vaccine. About 15 minutes after shot was given pt waved down parking attendant and asked for a nurse. 2 nurses arrived at pt's car. Pt reported that she first started feeling itchy on a bug bite on her arm which was red. She then stated it went from her bug bite to feeling tingly/burning on her lips. Pt reported she hadn't eaten much today and had drank hardly any water today. Pt's vitals were 152/92 to which pt stated she takes BP meds and her BP is at times higher than that. Her HR was 64, resp 22, SpO2 98%. Pt stayed for an extra 15 minutes then stated she was feeling better and wanted to go home.
39 2021-03-25 injection site pain Sore arm at injection site- 7:00PM 3/24/2021 Headache - 1:00PM 3/25/2021 Swollen left armpit- 6:00PM... Read more
Sore arm at injection site- 7:00PM 3/24/2021 Headache - 1:00PM 3/25/2021 Swollen left armpit- 6:00PM 3/25/2022 Fatigue & body aches - 6:00PM 3/25/2021
39 2021-03-26 bruising Symptoms showed up one at a time. Arm soreness was gone by Tuesday. Tuesday night with right upper ... Read more
Symptoms showed up one at a time. Arm soreness was gone by Tuesday. Tuesday night with right upper back dull pain. Headache, chills, swollen lymph nodes to neck and left armpit, body ages, fatigue, multiple bruising to both legs associated with soreness and pain. Went to ED 0300 am Thursday. 2 liters IV bills plus IV Toradol. Had minimal relief at the time so released with Tylenol #3. Takes pain away but comes right back once med wore off. Added Ibuprofen. Helps but pain comes back with bad chills and headache.
39 2021-03-27 injection site pain Fever, chills, headache, nausea, vomiting, dizziness like I was going to pass out. Sensitive to lig... Read more
Fever, chills, headache, nausea, vomiting, dizziness like I was going to pass out. Sensitive to lightens arm pain near injection sight.
39 2021-03-27 injection site pain Severe vomiting, diarrhea, chills, fever, muscle ache, headache, fatigue and sore arm at shot locati... Read more
Severe vomiting, diarrhea, chills, fever, muscle ache, headache, fatigue and sore arm at shot location. Continued nausea
39 2021-03-27 hives, itchy rash Welts and rash, very itchy all over my body.
39 2021-03-29 rash Fatigue; rash on my front torso, left side.; patient accidently may have received the vaccine withou... Read more
Fatigue; rash on my front torso, left side.; patient accidently may have received the vaccine without being diluted/I was the victim of a medication error; patient accidently may have received the vaccine without being diluted/I was the victim of a medication error; arm sore/right arm soreness; Headache; This is a spontaneous report from a contactable pharmacist and nurse (patient) and consumer via Medical information team. A 39 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: 01Mar2021), via intramuscular in the right arm (deltoid) on 19Jan2021 09:30 at 1.8 mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 19Jan2021 and stated that she was a victim of a medication error and needed some guidance on how to move forward. An RN (registered nurse) injected her with a 1 ml syringe and then proceeded to say that she didn't give her the diluent and proceeded to give the patient a 3 ml syringe in the same deltoid. She was having some side effects including arm sore and a headache, so the patient was assuming that she at least got some medicine, but she was not sure how much or what was in either injection she received. She was not sure what kind of dose she received. The patient accidently may have received the vaccine without being diluted. The patient wanted to know what to do now for getting the correct dosage of the vaccine and if she should repeat the series or continue with the second dose and get antibody tests. The patient wanted to know what her options are. Upon follow up on 01Feb2021 and 10Feb2021, it was reported that COVID-19 vaccine was administered incorrectly to the patient and was reported as medically significant serious event. The patient reported that she tried to place a report a couple of weeks ago regarding the vaccine potentially being administered incorrectly. She was not able to reach anyone when she contacted us previously. She reached medical information, but she is unsure if she was able to make a report. The patient further clarified COVID 19 vaccine being administered incorrectly as they had an immunization nurse come to help with their vaccine clinic. For some unknown reason the nurse was giving people two shots at that vaccine administration. Nurse administered one shot that was of the diluted vaccine and one was of the diluent. Caller stated she does not know why the nurse did it this way. The patient has had no side effects from this occurrence that she is aware of. The pharmacist considered the event initially as serious then later provided as medically significant. She feels this way as the patient did not get the full dose and may not fully be protected against COVID. The patient did not directly show the immunization nurse the process of how to administer. The pharmacist was informed by the patient that she got two shots in one setting. The patient received the diluent first the 1.8ml injected and then another injection, the actual vaccine. The diluent was sodium chloride 0.9%. The facility where the most recent COVID-19 vaccine was administered was in the Pharmacy/Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The nurse was given a vial of Pfizer COVID vaccine and a vial of sodium chloride 0.9% (2mL single dose vial, NDC 63323-186-04). It was explained to the nurse to dilute the active vaccine with 1.8 mL (using 3mL 23G x 1" syringe/needle) of diluent and draw shots from this mixture (using 1mL 25G x 1") vanish point syr/needle). 1.8mL of diluent was injected into the vaccine vial and the nurse was told to draw up vaccine with the smaller needles. She asked if the patients should expect 2 doses. Assuming she meant the two-dose COVID vaccine series (21 days apart), the reported said yes, each patient gets two shots. Based on the report, the nurse then drew up 0.3mL of diluted vaccine into a new syringe/needle (23G) and filled up the other smaller syringe with diluent. Since there were two vials of Pfizer COVID vaccine to be reconstituted, the original fear was that she used the undiluted Pfizer COVID vial to draw up the first dose, but based on the volume in the second COVID vial (had not been used or added to), the only opened vial at the time was the vial already mixed with diluent. So the patient received 0.3mL of diluted vaccine in the 23G syringe and then received 0.3mL of diluent as a second injection. The patient was not admitted to the hospital. The patient provided information to the nurse regarding the reported adverse events with the use of BNT162B2. It was unknown if the nurse considered the Pfizer product had a causal effect to the adverse event. No treatment was given to the patient for the events. The patient stated, "I received my first dose of Pfizer COVID-19 vaccine on Tuesday, 19Jan2021. I was injected with a 1 mL syringe in the right deltoid by the Registered Nurse administering the vaccine. I was then injected with a 3 mL syringe in the right deltoid by the Registered Nurse administering the vaccine. I am unable to validate the dose because it was not administered according to Pfizer's instructions and because there are discrepancies in the documentation. These discrepancies include, order of the injections and the amount of fluid present in the 3mL syringe. Since the injections received on 19Jan2021, I have experienced the following symptoms: headache, fatigue, right arm soreness and a 1" x 0.5" rash on my front torso, left side. I contacted Pfizer on Thursday, 21Jan2021. Pfizer had no previous record of a medication error of this nature and was unable to offer guidance since the medications administered could not be verified. Pfizer was not able to provide guidance on an invalid dose because there was no recommendations for an invalid dose of Pfizer COVID-19 vaccine at this time. The outcome of the events was unknown. Information on the lot/batch number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: suspect product data (lot number was unknown). Follow-up (28Jan2021 and 28Jan2021): New information received from contactable pharmacist and consumer in response to HCP telephonic follow up activity includes: reporter's fax number added and clinical information updated. Information about lot and batch number was requested. Follow-up (06Mar2021): This follow up report contains no new safety information. Follow-up (15Mar2021): This is a follow-up report combining information from duplicate reports 2021057789 and 2021045475. The current and all subsequent information will be reported under manufacturer report number 2021045475. New information included: new reporter, product details, upgrade the case to serious (patient accidently may have received the vaccine without being diluted upgraded from non-serious to serious), new events (arm sore/right arm soreness, Headache, Fatigue, rash on my front torso, left side.).; Sender's Comments: The patient accidently may have received the vaccine without being diluted. It was noted that "An RN (registered nurse) injected her with a 1 ml syringe and then proceeded to say that she didn't give her the diluent and proceeded to give the patient a 3 ml syringe in the same deltoid."
39 2021-03-29 vaccination site pain sore injection site arm; This is a spontaneous report from a non-contactable consumer, the patient. ... Read more
sore injection site arm; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown) via an unspecified route of administration on an unspecified date (at the age of 39-years-old) as a single dose for COVID-19 immunization. The patient had no medical history and no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included escitalopram oxalate (LEXAPRO). On 26Feb2021, the patient experienced sore injection site arm. The patient was not treated for sore injection site arm. The clinical outcome of sore injection site arm was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
39 2021-03-30 bruising Anaphylactic reaction (I could not swallow, I was short of breath, I got 2 bruises on my face, nause... Read more
Anaphylactic reaction (I could not swallow, I was short of breath, I got 2 bruises on my face, nausea, tachycardia) at the first dose of the Pfizer vaccine, which I was treated immediately in the emergency room with Epinephrine, Benadryl, Decadron y Albuterol. I was discharged the same day. I was treated in observation at hospital.
39 2021-04-01 injection site pain Pain at injection site and into armpit Headache Slight chills Aches Fatigue
39 2021-04-01 injection site pain Symptoms started about 2pm. Abdominal pain, nausea, diarrhea, headache, fatigue, muscle soreness, in... Read more
Symptoms started about 2pm. Abdominal pain, nausea, diarrhea, headache, fatigue, muscle soreness, injection site discomfort/pain. Breakthrough bleeding
39 2021-04-04 hives 12 hours after receives the vaccine I experienced heart palpatations, high blood pressure, hives ins... Read more
12 hours after receives the vaccine I experienced heart palpatations, high blood pressure, hives inside mouth (on tongue and throat), numbness in arm, numbness in left side of face, numbness in left neck and ear. Primary care doctor advised I was having a reaction and to go to the ER/Hospital. I was admitted and treated for reaction at the hospital.
39 2021-04-09 hives decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Al... Read more
decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Allergic reaction which included hives, itchy throat, eyes, nose, and ears, and hives; fast heart rate; flushing; lightheaded; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; This is a spontaneous report from a contactable other HCP (patient). A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma, allergies, inflammatory bowel disease. There was no COVID prior vaccination, no other vaccine within 4 weeks prior to the COVID vaccine, and no COVID tested post vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); lisdexamfetamine mesilate (VYVANSE); breo all within 2 weeks of vaccination. The patient experienced allergic reaction which included hives, itchy throat, eyes, nose, and ears; mild vasovagal reaction which included flushing, fast heart rate, lightheaded, and decreased hearing all on 26Mar2021 17:15 and resulted in Doctor or other healthcare professional office/clinic visit. Treatments included antihistamines and steroids. The events outcome was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the contributory role of the suspect product is possible.
39 2021-04-14 injection site pain, injection site pruritus I immediately felt dizzy, like I was drunk. At around 4pm, I started feeling wheezy. It felt like th... Read more
I immediately felt dizzy, like I was drunk. At around 4pm, I started feeling wheezy. It felt like there was a mastiff sitting on my chest. I took some benadryl, which helped. The next day, the feeling persisted and I had a mild cough, especially while lying down. More benadryl. Same on the third day. I did not seek medical attention because I didn't think it was an extraordinary reaction and I have had much worse reactions to other things in the past that have been managed with benadryl. I thought what I was experiencing was an expected side effect based on the information I had been given. The feeling started to ease by the 4th day, but then the insomnia, mood swings, exhaustion and body aches set in. The cough was sporadic, but still present. Today, I still get the heavy chest feeling intermittently, activity doesn't seem to have any effect or cause. My arm still itches at the injection site and hurts when touched. I went back to get my second dose on 4/9. When the nurse asked me if I had had any adverse reactions to the first one, I told her about the chest heaviness and coughing and the other symptoms. She stopped what she was doing and called her medical director. They both decided that the first response was enough of an anaphylactic reaction to be a caution for the second. They refused to give me the second dose because they thought the second would elicit a much worse reaction - possibly to the point of intubation. They told me that I would have to be evaluated by a physician and that I would need a "doctor's note" in order to get the second vaccine.
39 2021-04-14 injection site redness Large red ring around the injection site still there after 48 hours, severe chills, headache and bod... Read more
Large red ring around the injection site still there after 48 hours, severe chills, headache and body aches, tingling mouth and some tightness of throat immediately after injection
39 2021-04-14 injection site pain, injection site swelling Myalgia for about 24 h. injection site pain and swelling. Lymphadenopathy on the underarm of injecti... Read more
Myalgia for about 24 h. injection site pain and swelling. Lymphadenopathy on the underarm of injection site (left arm) that lasted for about 5 days
39 2021-04-14 rash Red rash on chest and face, tingling feet, tongue swollen (patient said), child. Drove home. Refuse... Read more
Red rash on chest and face, tingling feet, tongue swollen (patient said), child. Drove home. Refused transportation to hospital.
39 2021-04-15 itchy skin, rash Starting getting a rash in the form of chicken pox like bumps that itched all over my body.; Startin... Read more
Starting getting a rash in the form of chicken pox like bumps that itched all over my body.; Starting getting a rash in the form of chicken pox like bumps that itched all over my body.; This is a spontaneous report received from a contactable consumer (patient). A 39-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: El1284, Expiration date was not reported), via an unspecified route of administration in Arm Left on 16Jan2021 15:30 as single dose for covid-19 immunization. The patient had no relevant medical history and had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC), buspirone HCL and Yeast Gard supplement. On 26Jan2021, the patient started getting a rash in the form of chicken pox like bumps that itched all over my body. The patient's adverse event resulted in emergency room/department or urgent care. The patient received treatment with steroid pill and topical cream. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovering.
39 2021-04-17 vaccination site redness increased intracranial pressure; Pseudotumor Cerebri; Transverse sinus stenosis; left sided pulsatil... Read more
increased intracranial pressure; Pseudotumor Cerebri; Transverse sinus stenosis; left sided pulsatile tinnitus; severe headache; Postural Orthostatic Tachycardia Syndrome; dizzy and light headed; Then I developed a red circle around the injection site a week after the injection; This is a spontaneous report received from contactable consumer (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 18Mar2021 12:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. No known drug allergies. The patient received other concomitant medications within 2 weeks of vaccination (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 18Mar2021 13:15. The patient became dizzy and light headed within 30 minutes of receiving the first dose. The patient believed this was related to her postural orthostatic tachycardia syndrome (POTS). The symptoms lasted for approximately 12 hours. She also developed symptoms of increased intracranial pressure the morning after she received the first dose. The patient believed this was related to her pseudotumor cerebri (PTC) and transverse sinus stenosis (TSS). The symptoms included left sided pulsatile tinnitus and a severe headache. These symptoms lasted for approximately one week. Then she developed a red circle around the injection site a week after the injection. The patient contacted her neurologist as a result of all of symptoms. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. Information about lot/batch number has been requested.
39 2021-04-23 vaccination site swelling, vaccination site pain The injection site swollen and painful; The injection site swollen and painful; That side felt a lit... Read more
The injection site swollen and painful; The injection site swollen and painful; That side felt a little heavy; This is a spontaneous report from a contactable consumer(patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration at left arm on 09Feb2021 11:30 as single dose for Covid-19 immunization. Patient was 39 years old at the time of vaccination. Medical history included Lupus, autoimmune arthritis, vitamin D deficiency, anemia and high blood pressure. Patient was tested positive for covid-19 prior to vaccination. The patient previously took Reglan and experienced allergy. On 09Feb2021 at 05:30 PM the patient had injection site swollen and painful and that side felt a little heavy. Outcome of the events was recovering.
39 2021-04-26 itchy skin Itchiness all over her body; Weird taste in her mouth; dizzy; The initial safety information receive... Read more
Itchiness all over her body; Weird taste in her mouth; dizzy; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 12Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8735) via an unspecified route of administration, administered on the left deltoid on 31Mar2021 18:00 at a single dose for COVID-19 immunization. The patient had no medical history. Family medical history included that her dad has severe allergies. There were no concomitant medications. On 31Mar2021, after 1st dose of the Pfizer covid vaccine, she experienced weird taste in mouth and felt little dizzy both went away immediately, not too concerned. Saturday 03Apr2021 until Saturday 10Apr2021, had itchiness all over her body, she was asking since she had a mild reaction, when she goes next week, if it will be really bad. It was really bad itching, she didn't think it would go away. Patient thought she had a reaction to the first dose of the covid vaccine, it was not deadly. She was trying to figure out if it was safe to her to get the second dose of the covid vaccine next week. Itchiness all over her body: The only place she did not itch was her hands and feet. Her scalp, back and everything itched. She mostly itched on her torso and scalp. She even itched inside of her ears. She does not take any medications. She was healthy. She has no known drug allergies. She has not started any new products. She kept going about her business, but the itching was getting worse and worse until this weekend. Last Wednesday, 07Apr2021, the itching was so bad that she took a Benadryl to see if it would help. She does not like to take medications. She also used calamine lotion. She took Benadryl children's dose and it did not help the itching. She thinks that the dose was 10mg, but she does not know for sure. It was a new package, she had just bought it. Benadryl children's dose did not help at all. All of a sudden, the itching resolved on Saturday, 10Apr2021. She was out a lot in the sun all day Saturday. The sun seemed to help, she does not know if it was related. She did not have any hives. It felt like chicken pox to her but with no pustules. The itchiness all over her body was awful. She does not know. She has never had anything like this happen to her before. Her concern was if she had a mild reaction to the first dose of the covid vaccine, what was going to be like whenever she goes next week for her second dose of the covid vaccine. She was asking if it will be really bad. She was itching so bad that she took a Benadryl to see if it would help. She took Benadryl children's dose and it did not help the itching. Event itching was reported as serious, medically significant. After reviewing call recording, patient reported when she was at the vaccine facility nothing really major happened, she had a little bit of a weird taste in her mouth, nothing strange. She did get a little bit dizzy but nothing that did not wear off shortly thereafter, so she went about her life normally. The weird taste and dizzy feeling started within minutes of receiving the vaccine. The events did not require a visit to emergency room and physician office. She was lucky enough to work with doctors, so she just talked to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was in a pharmacy. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the event itchiness all over her body was recovered on 10Apr2021, while the other events recovered on 31Mar2021.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported pruritus cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
39 2021-04-30 shingles Hepatitis c 0.9 positive; Herpes or shingles on groin; Extreme fatigue; Fever; This is a spontaneous... Read more
Hepatitis c 0.9 positive; Herpes or shingles on groin; Extreme fatigue; Fever; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 24Mar2021 13:30 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient experienced Hepatitis c 0.9 positive, Herpes or shingles on groin, extreme fatigue, and fever on 11Apr2021. The patient underwent lab tests and procedures which included nasal swab: negative (covid tested post vaccination) on 15Apr2021 and Hepatitis C 0.9 positive on 11Apr2021. Therapeutic measures were taken as a result of the events which included Valtrex, cough syrup, antibiotics as treatment. The patient received the second dose of BNT162B2, administered in arm right on 14Apr2021 08:00. The outcome of the events was not recovered. Information on the lot/batch number has been requested.